LABELS · 440beed5-a673-423d-84e8-4f3432c37ee8

Renova

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Preserved label snapshot, not confirmation of a current approved indication. Approval/withdrawal status must be checked for the exact disease, setting and regimen.

Label effective date: 2026-02-24
Captured: 2026-09-09T23:37:44.904352+00:00
Current indication reconciliation: Not reconciled

Indications and usage: exact source text

INDICATIONS AND USAGE (To understand fully the indication for this product, please read the entire INDICATIONS AND USAGE section of the labeling.) RENOVA (tretinoin cream) 0.02% is indicated as an adjunctive agent (see second bullet point below) for use in the mitigation (palliation) of fine facial wrinkles in patients who use comprehensive skin care and sunlight avoidance programs. RENOVA (tretinoin cream) 0.02% DOES NOT ELIMINATE WRINKLES, REPAIR SUN-DAMAGED SKIN, REVERSE PHOTOAGING, or RESTORE MORE YOUTHFUL or YOUNGER SKIN. In double-blind, vehicle-controlled clinical studies, many patients in the vehicle group achieved desired palliative effects on fine wrinkling of facial skin with the use of comprehensive skin care and sunlight avoidance programs including sunscreens, protective clothing, and non-prescription emollient creams. • RENOVA (tretinoin cream) 0.02% has NOT DEMONSTRATED A MITIGATING EFFECT on significant signs of chronic sunlight exposure such as coarse or deep wrinkling, tactile roughness, mottled hyperpigmentation, lentigines, telangiectasia, skin laxity, keratinocytic atypia, melanocytic atypia, or dermal elastosis. • RENOVA (tretinoin cream) 0.02% should be used under medical supervision as an adjunct to a comprehensive skin care and sunlight avoidance program that includes the use of effective sunscreens (minimum SPF of 15) and protective clothing. • Patients with visible actinic keratosis and patients with a history of skin cancer were excluded from clinical trials of RENOVA (tretinoin cream) 0.02%. Thus the effectiveness and safety of RENOVA (tretinoin cream) 0.02% in these populations are not known at this time. • Neither the safety nor the effectiveness of RENOVA (tretinoin cream) 0.02% for the prevention or treatment of actinic keratoses or skin neoplasms has been established. • Neither the safety nor the efficacy of using RENOVA (tretinoin cream) 0.02% daily for greater than 52 weeks has been established, and daily use beyond 52 weeks has not been systematically and histologically investigated in adequate and well-controlled trials (see WARNINGS ). Clinical Trials Four adequate and well-controlled multi-center trials and one single-center randomized, controlled trial were conducted involving a total of 324 evaluable patients treated with RENOVA (tretinoin cream) 0.02% and 332 evaluable patients treated with the vehicle cream on the face for 24 weeks with a comprehensive skin care and sun avoidance program, to assess the effects on fine and coarse wrinkling, mottled hyperpigmentation, tactile skin roughness, and laxity. Patients were evaluated at baseline on a 10-unit scale and changes from that baseline rating were categorized as follows: Worsening: Increase of 1 unit or more. No improvement: No change. Minimal improvement: Reduction of 1 unit. Mild improvement: Reduction of 2 units. Moderate improvement: Reduction of 3 units or more. In these trials, the fine and coarse wrinkling, mottled hyperpigmentation, tactile roughness, and laxity of the facial skin were thought to be caused by multiple factors which included intrinsic aging or environmental factors, such as chronic sunlight exposure. Two of the five trials provided adequate demonstration of efficacy for mitigation of fine facial wrinkling. No two of the five trials adequately demonstrated efficacy for mitigation of coarse wrinkling, mottled hyperpigmentation, tactile skin roughness, and laxity. Data for fine wrinkling (the indication for which RENOVA (tretinoin cream) 0.02% demonstrated efficacy) from all five trials (four studies in lightly pigmented subjects with Fitzpatrick Skin Types I-III and one study in darkly pigmented subjects with Fitzpatrick Skin Types IV-VI) is provided below: FINE WRINKLING IN LIGHTLY PIGMENTED SUBJECTS Subjects Using RENOVA (tretinoin cream) 0.02% + CSP * (N=279) Vehicle + CSP * (N=280) A single-center study (N=107) in darkly pigmented, mostly African-American, subjects with Fitzpatrick Skin Types IV-VI demonstrated minimal or mild improvement in fine facial wrinkling in 43% of patients using Vehicle + CSP* compared to 29% of subjects using RENOVA (tretinoin cream) 0.02% + CSP*. Although fewer darkly pigmented subjects improved with RENOVA (tretinoin cream) 0.02% than with vehicle, these findings may reflect the small size of this study. * CSP = Comprehensive skin protection and sunlight avoidance programs including use of sunscreens, protective clothing, and non-prescription emollient creams. Worsened 1% 3% No Change 40% 58% Minimal Improvement 35% 27% Mild Improvement 15% 9% Moderate Improvement 10% 3% Self-assessment of fine wrinkles after 24 weeks of treatment with either RENOVA (tretinoin cream) 0.02% or Vehicle from the four studies in lightly pigmented patients showed the following: No studies have been conducted comparing the facial irritation or efficacy of RENOVA (tretinoin cream) 0.02% to RENOVA (tretinoin cream) 0.05% (older marketed formulation). Patients may lose some of the mitigating effects of RENOVA (tretinoin cream) 0.02% after 12 weeks of discontinuation of RENOVA (tretinoin cream) 0.02% from their comprehensive skin care and sunlight avoidance program. figure1.jpg

Full extracted label fields

application numbers

NDA021108

boxed warning exact

brand names

Renova

current indication status

not_reconciled

dailymed set url

https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=9f0a0e8d-1051-48a4-80c5-1bd260dd9c36

generic names

TRETINOIN

440beed5-a673-423d-84e8-4f3432c37ee8

indications and usage exact

INDICATIONS AND USAGE (To understand fully the indication for this product, please read the entire INDICATIONS AND USAGE section of the labeling.) RENOVA (tretinoin cream) 0.02% is indicated as an adjunctive agent (see second bullet point below) for use in the mitigation (palliation) of fine facial wrinkles in patients who use comprehensive skin care and sunlight avoidance programs. RENOVA (tretinoin cream) 0.02% DOES NOT ELIMINATE WRINKLES, REPAIR SUN-DAMAGED SKIN, REVERSE PHOTOAGING, or RESTORE MORE YOUTHFUL or YOUNGER SKIN. In double-blind, vehicle-controlled clinical studies, many patients in the vehicle group achieved desired palliative effects on fine wrinkling of facial skin with the use of comprehensive skin care and sunlight avoidance programs including sunscreens, protective clothing, and non-prescription emollient creams. • RENOVA (tretinoin cream) 0.02% has NOT DEMONSTRATED A MITIGATING EFFECT on significant signs of chronic sunlight exposure such as coarse or deep wrinkling, tactile roughness, mottled hyperpigmentation, lentigines, telangiectasia, skin laxity, keratinocytic atypia, melanocytic atypia, or dermal elastosis. • RENOVA (tretinoin cream) 0.02% should be used under medical supervision as an adjunct to a comprehensive skin care and sunlight avoidance program that includes the use of effective sunscreens (minimum SPF of 15) and protective clothing. • Patients with visible actinic keratosis and patients with a history of skin cancer were excluded from clinical trials of RENOVA (tretinoin cream) 0.02%. Thus the effectiveness and safety of RENOVA (tretinoin cream) 0.02% in these populations are not known at this time. • Neither the safety nor the effectiveness of RENOVA (tretinoin cream) 0.02% for the prevention or treatment of actinic keratoses or skin neoplasms has been established. • Neither the safety nor the efficacy of using RENOVA (tretinoin cream) 0.02% daily for greater than 52 weeks has been established, and daily use beyond 52 weeks has not been systematically and histologically investigated in adequate and well-controlled trials (see WARNINGS ). Clinical Trials Four adequate and well-controlled multi-center trials and one single-center randomized, controlled trial were conducted involving a total of 324 evaluable patients treated with RENOVA (tretinoin cream) 0.02% and 332 evaluable patients treated with the vehicle cream on the face for 24 weeks with a comprehensive skin care and sun avoidance program, to assess the effects on fine and coarse wrinkling, mottled hyperpigmentation, tactile skin roughness, and laxity. Patients were evaluated at baseline on a 10-unit scale and changes from that baseline rating were categorized as follows: Worsening: Increase of 1 unit or more. No improvement: No change. Minimal improvement: Reduction of 1 unit. Mild improvement: Reduction of 2 units. Moderate improvement: Reduction of 3 units or more. In these trials, the fine and coarse wrinkling, mottled hyperpigmentation, tactile roughness, and laxity of the facial skin were thought to be caused by multiple factors which included intrinsic aging or environmental factors, such as chronic sunlight exposure. Two of the five trials provided adequate demonstration of efficacy for mitigation of fine facial wrinkling. No two of the five trials adequately demonstrated efficacy for mitigation of coarse wrinkling, mottled hyperpigmentation, tactile skin roughness, and laxity. Data for fine wrinkling (the indication for which RENOVA (tretinoin cream) 0.02% demonstrated efficacy) from all five trials (four studies in lightly pigmented subjects with Fitzpatrick Skin Types I-III and one study in darkly pigmented subjects with Fitzpatrick Skin Types IV-VI) is provided below: FINE WRINKLING IN LIGHTLY PIGMENTED SUBJECTS Subjects Using RENOVA (tretinoin cream) 0.02% + CSP * (N=279) Vehicle + CSP * (N=280) A single-center study (N=107) in darkly pigmented, mostly African-American, subjects with Fitzpatrick Skin Types IV-VI demonstrated minimal or mild improvement in fine facial wrinkling in 43% of patients using Vehicle + CSP* compared to 29% of subjects using RENOVA (tretinoin cream) 0.02% + CSP*. Although fewer darkly pigmented subjects improved with RENOVA (tretinoin cream) 0.02% than with vehicle, these findings may reflect the small size of this study. * CSP = Comprehensive skin protection and sunlight avoidance programs including use of sunscreens, protective clothing, and non-prescription emollient creams. Worsened 1% 3% No Change 40% 58% Minimal Improvement 35% 27% Mild Improvement 15% 9% Moderate Improvement 10% 3% Self-assessment of fine wrinkles after 24 weeks of treatment with either RENOVA (tretinoin cream) 0.02% or Vehicle from the four studies in lightly pigmented patients showed the following: No studies have been conducted comparing the facial irritation or efficacy of RENOVA (tretinoin cream) 0.02% to RENOVA (tretinoin cream) 0.05% (older marketed formulation). Patients may lose some of the mitigating effects of RENOVA (tretinoin cream) 0.02% after 12 weeks of discontinuation of RENOVA (tretinoin cream) 0.02% from their comprehensive skin care and sunlight avoidance program. figure1.jpg

indications and usage tables exact

<table width="70%"><col width="35%"/><col width="33%"/><tbody><tr><td styleCode="Toprule " valign="top"><paragraph>Worsening:</paragraph></td><td styleCode="Toprule " valign="top"><paragraph>Increase of 1 unit or more.</paragraph></td></tr><tr><td valign="top"><paragraph>No improvement:</paragraph></td><td valign="top"><paragraph>No change.</paragraph></td></tr><tr><td valign="top"><paragraph>Minimal improvement:</paragraph></td><td valign="top"><paragraph>Reduction of 1 unit.</paragraph></td></tr><tr><td valign="top"><paragraph>Mild improvement:</paragraph></td><td valign="top"><paragraph>Reduction of 2 units.</paragraph></td></tr><tr><td styleCode="Botrule " valign="top"><paragraph>Moderate improvement:</paragraph></td><td styleCode="Botrule " valign="top"><paragraph>Reduction of 3 units or more.</paragraph></td></tr></tbody></table>
<table width="100%"><col width="30%"/><col width="29%"/><col width="38%"/><thead><tr><th align="center" colspan="3" styleCode="Rrule Botrule Lrule Toprule " valign="top"><content styleCode="bold">FINE WRINKLING IN LIGHTLY PIGMENTED SUBJECTS</content></th></tr><tr><th align="left" styleCode="Rrule Lrule Toprule Botrule " valign="top"/><th align="center" styleCode="Rrule Toprule Botrule " valign="middle"><content styleCode="bold">Subjects Using</content> <content styleCode="bold">RENOVA</content> <content styleCode="bold">(tretinoin cream)</content> <content styleCode="bold">0.02% + CSP<sup>*</sup></content> <content styleCode="bold">(N=279)</content></th><th align="center" styleCode="Rrule Toprule Botrule " valign="middle"><content styleCode="bold">Vehicle + CSP<sup>*</sup></content> <content styleCode="bold">(N=280)</content></th></tr></thead><tfoot><tr><td align="left" colspan="3" valign="top">A single-center study (N=107) in darkly pigmented, mostly African-American, subjects with Fitzpatrick Skin Types IV-VI demonstrated minimal or mild improvement in fine facial wrinkling in 43% of patients using Vehicle + CSP* compared to 29% of subjects using RENOVA (tretinoin cream) 0.02% + CSP*. Although fewer darkly pigmented subjects improved with RENOVA (tretinoin cream) 0.02% than with vehicle, these findings may reflect the small size of this study.</td></tr><tr><td align="left" colspan="3" valign="top"><sup>*</sup> CSP = Comprehensive skin protection and sunlight avoidance programs including use of sunscreens, protective clothing, and non-prescription emollient creams.</td></tr></tfoot><tbody><tr><td styleCode="Rrule Lrule Toprule Botrule " valign="top"><paragraph>Worsened</paragraph></td><td align="center" styleCode="Rrule Toprule Botrule " valign="middle"><paragraph>1%</paragraph></td><td align="center" styleCode="Rrule Toprule Botrule " valign="middle"><paragraph>3%</paragraph></td></tr><tr><td styleCode="Rrule Lrule Botrule " valign="top"><paragraph>No Change</paragraph></td><td align="center" styleCode="Rrule Botrule " valign="middle"><paragraph>40%</paragraph></td><td align="center" styleCode="Rrule Botrule " valign="middle"><paragraph>58%</paragraph></td></tr><tr><td styleCode="Rrule Lrule Botrule " valign="top"><paragraph>Minimal Improvement</paragraph></td><td align="center" styleCode="Rrule Botrule " valign="middle"><paragraph>35%</paragraph></td><td align="center" styleCode="Rrule Botrule " valign="middle"><paragraph>27%</paragraph></td></tr><tr><td styleCode="Rrule Lrule Botrule " valign="top"><paragraph>Mild Improvement</paragraph></td><td align="center" styleCode="Rrule Botrule " valign="middle"><paragraph>15%</paragraph></td><td align="center" styleCode="Rrule Botrule " valign="middle"><paragraph>9%</paragraph></td></tr><tr><td styleCode="Rrule Botrule Lrule " valign="top"><paragraph>Moderate Improvement</paragraph></td><td align="center" styleCode="Rrule Botrule " valign="middle"><paragraph>10%</paragraph></td><td align="center" styleCode="Rrule Botrule " valign="middle"><paragraph>3%</paragraph></td></tr></tbody></table>

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Source passages and status connections

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Passage 1 · positive indication candidate

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exact text: INDICATIONS AND USAGE (To understand fully the indication for this product, please read the entire INDICATIONS AND USAGE section of the labeling.) RENOVA (tretinoin cream) 0.02% is indicated as an adjunctive agent (see second bullet point below) for use in the mitigation (palliation) of fine facial wrinkles in patients who use comprehensive skin care and sunlight avoidance programs. RENOVA (tretinoin cream) 0.02% DOES NOT ELIMINATE WRINKLES, REPAIR SUN-DAMAGED SKIN, REVERSE PHOTOAGING, or RESTORE MORE YOUTHFUL or YOUNGER SKIN. In double-blind, vehicle-controlled clinical studies
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Passage 2 · unclassified context

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exact text: ated as an adjunctive agent (see second bullet point below) for use in the mitigation (palliation) of fine facial wrinkles in patients who use comprehensive skin care and sunlight avoidance programs. RENOVA (tretinoin cream) 0.02% DOES NOT ELIMINATE WRINKLES, REPAIR SUN-DAMAGED SKIN, REVERSE PHOTOAGING, or RESTORE MORE YOUTHFUL or YOUNGER SKIN. In double-blind, vehicle-controlled clinical studies, many patients in the vehicle group achieved desired palliative effects on fine wrinkling of facial skin with the use of comprehensive skin care a
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exact text: rehensive skin care and sunlight avoidance programs. RENOVA (tretinoin cream) 0.02% DOES NOT ELIMINATE WRINKLES, REPAIR SUN-DAMAGED SKIN, REVERSE PHOTOAGING, or RESTORE MORE YOUTHFUL or YOUNGER SKIN. In double-blind, vehicle-controlled clinical studies, many patients in the vehicle group achieved desired palliative effects on fine wrinkling of facial skin with the use of comprehensive skin care and sunlight avoidance programs including sunscreens, protective clothing, and non-prescription emollient creams. • RENOVA (tretinoin cream) 0.02% has NOT DEMONSTRATED A MITIGATING EFFECT on significant signs of chronic sunlight exposure such as coarse or deep wrinkling, tactile roughness, mottled hyperpigmentat
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Passage 4 · limitation of use

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exact text: tive effects on fine wrinkling of facial skin with the use of comprehensive skin care and sunlight avoidance programs including sunscreens, protective clothing, and non-prescription emollient creams. • RENOVA (tretinoin cream) 0.02% has NOT DEMONSTRATED A MITIGATING EFFECT on significant signs of chronic sunlight exposure such as coarse or deep wrinkling, tactile roughness, mottled hyperpigmentation, lentigines, telangiectasia, skin laxity, keratinocytic atypia, melanocytic atypia, or dermal elastosis. • RENOVA (tretinoin cream) 0.02% should be used under medical supervision as an adjunct to a comprehensive skin care and sunlight avoidance program that includes the use of effective sunscreens (mini
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exact text: • RENOVA (tretinoin cream) 0.02% has NOT DEMONSTRATED A MITIGATING EFFECT on significant signs of chronic sunlight exposure such as coarse or deep wrinkling, tactile roughness, mottled hyperpigmentation, lentigines, telangiectasia, skin laxity, keratinocytic atypia, melanocytic atypia, or dermal elastosis.
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Passage 5 · unclassified context

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exact text: Worsening: Increase of 1 unit or more. No improvement: No change. Minimal improvement: Reduction of 1 unit. Mild improvement: Reduction of 2 units. Moderate improvement: Reduction of 3 units or more. In these trials, the fine and coarse wrinkling, mottled hyperpigmentation, tactile roughness, and laxity of the facial skin were thought to be caused by multiple factors which included intrinsic aging or environmental factors, such as chronic sunlight exposure. Two of the five trials provided adequate demonstration of efficacy for mitigation of fine facial wrinkling. No two of the five trials adequately demonstrated efficacy for mitigation of coarse wrinkli
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exact text: In these trials, the fine and coarse wrinkling, mottled hyperpigmentation, tactile roughness, and laxity of the facial skin were thought to be caused by multiple factors which included intrinsic aging or environmental factors, such as chronic sunlight exposure.
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exact text: igmentation, tactile roughness, and laxity of the facial skin were thought to be caused by multiple factors which included intrinsic aging or environmental factors, such as chronic sunlight exposure. Two of the five trials provided adequate demonstration of efficacy for mitigation of fine facial wrinkling. No two of the five trials adequately demonstrated efficacy for mitigation of coarse wrinkling, mottled hyperpigmentation, tactile skin roughness, and laxity. Data for fine wrinkling (the indication f
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exact text: which included intrinsic aging or environmental factors, such as chronic sunlight exposure. Two of the five trials provided adequate demonstration of efficacy for mitigation of fine facial wrinkling. No two of the five trials adequately demonstrated efficacy for mitigation of coarse wrinkling, mottled hyperpigmentation, tactile skin roughness, and laxity. Data for fine wrinkling (the indication for which RENOVA (tretinoin cream) 0.02% demonstrated efficacy) from all five trials (four studies in lightly pigmented subjects with Fitzpatrick Skin Types I-
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exact text: No two of the five trials adequately demonstrated efficacy for mitigation of coarse wrinkling, mottled hyperpigmentation, tactile skin roughness, and laxity.
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exact text: for mitigation of fine facial wrinkling. No two of the five trials adequately demonstrated efficacy for mitigation of coarse wrinkling, mottled hyperpigmentation, tactile skin roughness, and laxity. Data for fine wrinkling (the indication for which RENOVA (tretinoin cream) 0.02% demonstrated efficacy) from all five trials (four studies in lightly pigmented subjects with Fitzpatrick Skin Types I-III and one study in darkly pigmented subjects with Fitzpatrick Skin Types IV-VI) is provided below: FINE WRINKLING IN LIGHTLY PIGMENTED SUBJECTS Subjects Using RENOVA (tretinoin cream) 0.02% + CSP * (N=279) Vehicle + CSP * (N=280) A single-center study (N=107) in darkly pigmented, mostly African-American, subjects with Fitzpatrick Skin Types IV-VI demonstrated minimal or mild improvement in fine facial wrinkling in 43% of patients using Vehicle + CSP* compared to 29% of subjects using RENOVA (tretinoin cream) 0.02% + CSP*. Although fewer darkly pigmented subjects improved with RENOVA (tretinoin cream) 0.02% than with vehicle, these findings may reflect the small size of this study. * CSP = Comprehensive skin protection
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exact text: Data for fine wrinkling (the indication for which RENOVA (tretinoin cream) 0.02% demonstrated efficacy) from all five trials (four studies in lightly pigmented subjects with Fitzpatrick Skin Types I-III and one study in darkly pigmented subjects with Fitzpatrick Skin Types IV-VI) is provided below: FINE WRINKLING IN LIGHTLY PIGMENTED SUBJECTS Subjects Using RENOVA (tretinoin cream) 0.02% + CSP * (N=279) Vehicle + CSP * (N=280) A single-center study (N=107) in darkly pigmented, mostly African-American, subjects with Fitzpatrick Skin Types IV-VI demonstrated minimal or mild improvement in fine facial wrinkling in 43% of patients using Vehicle + CSP* compared to 29% of subjects using RENOVA (tretinoin cream) 0.02% + CSP*.
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exact text: ick Skin Types IV-VI demonstrated minimal or mild improvement in fine facial wrinkling in 43% of patients using Vehicle + CSP* compared to 29% of subjects using RENOVA (tretinoin cream) 0.02% + CSP*. Although fewer darkly pigmented subjects improved with RENOVA (tretinoin cream) 0.02% than with vehicle, these findings may reflect the small size of this study. * CSP = Comprehensive skin protection and sunlight avoidance programs including use of sunscreens, protective clothing, and non-prescription emollient creams. Worsened 1% 3% No Change 40% 58% Minimal
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exact text: Although fewer darkly pigmented subjects improved with RENOVA (tretinoin cream) 0.02% than with vehicle, these findings may reflect the small size of this study.
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exact text: ENOVA (tretinoin cream) 0.02% + CSP*. Although fewer darkly pigmented subjects improved with RENOVA (tretinoin cream) 0.02% than with vehicle, these findings may reflect the small size of this study. * CSP = Comprehensive skin protection and sunlight avoidance programs including use of sunscreens, protective clothing, and non-prescription emollient creams. Worsened 1% 3% No Change 40% 58% Minimal Improvement 35% 27% Mild Improvement 15% 9% Moderate Improvement 10% 3% Self-assessment of fine wrinkles after 24 weeks of treatment with either RENOVA (treti
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exact text: * CSP = Comprehensive skin protection and sunlight avoidance programs including use of sunscreens, protective clothing, and non-prescription emollient creams.
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exact text: ay reflect the small size of this study. * CSP = Comprehensive skin protection and sunlight avoidance programs including use of sunscreens, protective clothing, and non-prescription emollient creams. Worsened 1% 3% No Change 40% 58% Minimal Improvement 35% 27% Mild Improvement 15% 9% Moderate Improvement 10% 3% Self-assessment of fine wrinkles after 24 weeks of treatment with either RENOVA (tretinoin cream) 0.02% or Vehicle from the four studies in lightly pigmented patients showed the following: No studies have been conducted comparing the facial irritation or efficacy of RENOVA (tretinoin cream) 0.02% to RENOVA (tretinoin cream) 0.05% (older marketed formulation). Patients may lose some of the mitigating effects of RENOVA (tretinoin cream) 0.02% after 12 weeks of discontinuation of RENOVA (tretinoin cream) 0.02% from their comprehensive skin care and sunlight
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exact text: Worsened 1% 3% No Change 40% 58% Minimal Improvement 35% 27% Mild Improvement 15% 9% Moderate Improvement 10% 3% Self-assessment of fine wrinkles after 24 weeks of treatment with either RENOVA (tretinoin cream) 0.02% or Vehicle from the four studies in lightly pigmented patients showed the following: No studies have been conducted comparing the facial irritation or efficacy of RENOVA (tretinoin cream) 0.02% to RENOVA (tretinoin cream) 0.05% (older marketed formulation).
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Passage 23 · unclassified context

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exact text: ents showed the following: No studies have been conducted comparing the facial irritation or efficacy of RENOVA (tretinoin cream) 0.02% to RENOVA (tretinoin cream) 0.05% (older marketed formulation). Patients may lose some of the mitigating effects of RENOVA (tretinoin cream) 0.02% after 12 weeks of discontinuation of RENOVA (tretinoin cream) 0.02% from their comprehensive skin care and sunlight avoidance program. figure1.jpg
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exact text: Patients may lose some of the mitigating effects of RENOVA (tretinoin cream) 0.02% after 12 weeks of discontinuation of RENOVA (tretinoin cream) 0.02% from their comprehensive skin care and sunlight avoidance program. figure1.jpg
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Passage 24 · source table needs review

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exact text: <table width="70%"><col width="35%"/><col width="33%"/><tbody><tr><td styleCode="Toprule " valign="top"><paragraph>Worsening:</paragraph></td><td styleCode="Toprule " valign="top"><paragraph>Increase of 1 unit or more.</paragraph></td></tr><tr><td valign="top"><paragraph>No improvement:</paragraph></td><td valign="top"><paragraph>No change.</paragraph></td></tr><tr><td valign="top"><paragraph>Minimal improvement:</paragraph></td><td valign="top"><paragraph>Reduction of 1 unit.</paragraph></td></tr><tr><td valign="top"><paragraph>Mild improvement:</paragraph></td><td valign="top"><paragraph>Reduction of 2 units.</paragraph></td></tr><tr><td styleCode="Botrule " valign="top"><paragraph>Moderate improvement:</paragraph></td><td styleCode="Botrule " valign="top"><paragraph>Reduction of 3 units or more.</paragraph></td></tr></tbody></table>
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exact text: <table width="70%"><col width="35%"/><col width="33%"/><tbody><tr><td styleCode="Toprule " valign="top"><paragraph>Worsening:</paragraph></td><td styleCode="Toprule " valign="top"><paragraph>Increase of 1 unit or more.</paragraph></td></tr><tr><td valign="top"><paragraph>No improvement:</paragraph></td><td valign="top"><paragraph>No change.</paragraph></td></tr><tr><td valign="top"><paragraph>Minimal improvement:</paragraph></td><td valign="top"><paragraph>Reduction of 1 unit.</paragraph></td></tr><tr><td valign="top"><paragraph>Mild improvement:</paragraph></td><td valign="top"><paragraph>Reduction of 2 units.</paragraph></td></tr><tr><td styleCode="Botrule " valign="top"><paragraph>Moderate improvement:</paragraph></td><td styleCode="Botrule " valign="top"><paragraph>Reduction of 3 units or more.</paragraph></td></tr></tbody></table>
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Passage 25 · source table needs review

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exact text: <table width="100%"><col width="30%"/><col width="29%"/><col width="38%"/><thead><tr><th align="center" colspan="3" styleCode="Rrule Botrule Lrule Toprule " valign="top"><content styleCode="bold">FINE WRINKLING IN LIGHTLY PIGMENTED SUBJECTS</content></th></tr><tr><th align="left" styleCode="Rrule Lrule Toprule Botrule " valign="top"/><th align="center" styleCode="Rrule Toprule Botrule " valign="middle"><content styleCode="bold">Subjects Using</content> <content styleCode="bold">RENOVA</content> <content styleCode="bold">(tretinoin cream)</content> <content styleCode="bold">0.02% + CSP<sup>*</sup></content> <content styleCode="bold">(N=279)</content></th><th align="center" styleCode="Rrule Toprule Botrule " valign="middle"><content styleCode="bold">Vehicle + CSP<sup>*</sup></content> <content styleCode="bold">(N=280)</content></th></tr></thead><tfoot><tr><td align="left" colspan="3" valign="top">A single-center study (N=107) in darkly pigmented, mostly African-American, subjects with Fitzpatrick Skin Types IV-VI demonstrated minimal or mild improvement in fine facial wrinkling in 43% of patients using Vehicle + CSP* compared to 29% of subjects using RENOVA (tretinoin cream) 0.02% + CSP*. Although fewer darkly pigmented subjects improved with RENOVA (tretinoin cream) 0.02% than with vehicle, these findings may reflect the small size of this study.</td></tr><tr><td align="left" colspan="3" valign="top"><sup>*</sup> CSP = Comprehensive skin protection and sunlight avoidance programs including use of sunscreens, protective clothing, and non-prescription emollient creams.</td></tr></tfoot><tbody><tr><td styleCode="Rrule Lrule Toprule Botrule " valign="top"><paragraph>Worsened</paragraph></td><td align="center" styleCode="Rrule Toprule Botrule " valign="middle"><paragraph>1%</paragraph></td><td align="center" styleCode="Rrule Toprule Botrule " valign="middle"><paragraph>3%</paragraph></td></tr><tr><td styleCode="Rrule Lrule Botrule " valign="top"><paragraph>No Change</paragraph></td><td align="center" styleCode="Rrule Botrule " valign="middle"><paragraph>40%</paragraph></td><td align="center" styleCode="Rrule Botrule " valign="middle"><paragraph>58%</paragraph></td></tr><tr><td styleCode="Rrule Lrule Botrule " valign="top"><paragraph>Minimal Improvement</paragraph></td><td align="center" styleCode="Rrule Botrule " valign="middle"><paragraph>35%</paragraph></td><td align="center" styleCode="Rrule Botrule " valign="middle"><paragraph>27%</paragraph></td></tr><tr><td styleCode="Rrule Lrule Botrule " valign="top"><paragraph>Mild Improvement</paragraph></td><td align="center" styleCode="Rrule Botrule " valign="middle"><paragraph>15%</paragraph></td><td align="center" styleCode="Rrule Botrule " valign="middle"><paragraph>9%</paragraph></td></tr><tr><td styleCode="Rrule Botrule Lrule " valign="top"><paragraph>Moderate Improvement</paragraph></td><td align="center" styleCode="Rrule Botrule " valign="middle"><paragraph>10%</paragraph></td><td align="center" styleCode="Rrule Botrule " valign="middle"><paragraph>3%</paragraph></td></tr></tbody></table>
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exact text: <table width="100%"><col width="30%"/><col width="29%"/><col width="38%"/><thead><tr><th align="center" colspan="3" styleCode="Rrule Botrule Lrule Toprule " valign="top"><content styleCode="bold">FINE WRINKLING IN LIGHTLY PIGMENTED SUBJECTS</content></th></tr><tr><th align="left" styleCode="Rrule Lrule Toprule Botrule " valign="top"/><th align="center" styleCode="Rrule Toprule Botrule " valign="middle"><content styleCode="bold">Subjects Using</content> <content styleCode="bold">RENOVA</content> <content styleCode="bold">(tretinoin cream)</content> <content styleCode="bold">0.02% + CSP<sup>*</sup></content> <content styleCode="bold">(N=279)</content></th><th align="center" styleCode="Rrule Toprule Botrule " valign="middle"><content styleCode="bold">Vehicle + CSP<sup>*</sup></content> <content styleCode="bold">(N=280)</content></th></tr></thead><tfoot><tr><td align="left" colspan="3" valign="top">A single-center study (N=107) in darkly pigmented, mostly African-American, subjects with Fitzpatrick Skin Types IV-VI demonstrated minimal or mild improvement in fine facial wrinkling in 43% of patients using Vehicle + CSP* compared to 29% of subjects using RENOVA (tretinoin cream) 0.02% + CSP*. Although fewer darkly pigmented subjects improved with RENOVA (tretinoin cream) 0.02% than with vehicle, these findings may reflect the small size of this study.</td></tr><tr><td align="left" colspan="3" valign="top"><sup>*</sup> CSP = Comprehensive skin protection and sunlight avoidance programs including use of sunscreens, protective clothing, and non-prescription emollient creams.</td></tr></tfoot><tbody><tr><td styleCode="Rrule Lrule Toprule Botrule " valign="top"><paragraph>Worsened</paragraph></td><td align="center" styleCode="Rrule Toprule Botrule " valign="middle"><paragraph>1%</paragraph></td><td align="center" styleCode="Rrule Toprule Botrule " valign="middle"><paragraph>3%</paragraph></td></tr><tr><td styleCode="Rrule Lrule Botrule " valign="top"><paragraph>No Change</paragraph></td><td align="center" styleCode="Rrule Botrule " valign="middle"><paragraph>40%</paragraph></td><td align="center" styleCode="Rrule Botrule " valign="middle"><paragraph>58%</paragraph></td></tr><tr><td styleCode="Rrule Lrule Botrule " valign="top"><paragraph>Minimal Improvement</paragraph></td><td align="center" styleCode="Rrule Botrule " valign="middle"><paragraph>35%</paragraph></td><td align="center" styleCode="Rrule Botrule " valign="middle"><paragraph>27%</paragraph></td></tr><tr><td styleCode="Rrule Lrule Botrule " valign="top"><paragraph>Mild Improvement</paragraph></td><td align="center" styleCode="Rrule Botrule " valign="middle"><paragraph>15%</paragraph></td><td align="center" styleCode="Rrule Botrule " valign="middle"><paragraph>9%</paragraph></td></tr><tr><td styleCode="Rrule Botrule Lrule " valign="top"><paragraph>Moderate Improvement</paragraph></td><td align="center" styleCode="Rrule Botrule " valign="middle"><paragraph>10%</paragraph></td><td align="center" styleCode="Rrule Botrule " valign="middle"><paragraph>3%</paragraph></td></tr></tbody></table>
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Preserved source evidence · Not medical advice