TriangleNCT03392935 · REGISTRY CONDITION SEARCH
Efficacy of 1540 Nanometer Erbium Glass Laser to Improve Benign Dermatofibromas
Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.
- Phase
- NA
- Status at capture
- COMPLETED
- Registry last update
- 2023-05-08
This study is to find a more effective treatment for itchy, painful or unsightly dermatofibromas, that will improve symptoms of itch and/or pain and/or improve the appearance of dermatofibromas. This is an open-label study where subjects will receive a laser treatment at week 0, and week 4, and then 2 additional follow-up visits. Photographs will be taken at each visit and rated by blinded reviewers after the study to determine efficacy.
Open the original ClinicalTrials.gov record → · Download preserved record
What did the study report?
Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.
Participant flow
Baseline characteristics
Modified Patient and Observer Scar Assessment Scale Color Component Comparing Change From Baseline to Week 12.
Modified Patient and Observer Scar Assessment Scale Itch Component Comparing Change From Baseline to Week 12.
Modified Patient and Observer Scar Assessment Scale Texture Component Comparing Change From Baseline to Week 12.
Modified Patient and Observer Scar Assessment Scale Pain Component Comparing Change From Baseline to Week 12.
Adverse events
Limitations, agreements, and source contact
Who could take part
- eligibility Criteria
- Inclusion Criteria: * female or male, age 18-65, have at least one dermatofibroma of the skin, on the trunk or extremities, diagnosed by dermatologist, dermatofibroma is either itchy, painful or unattractive to the patient. Exclusion Criteria: * previous treatment to the dermatofibroma(s), pregnant or nursing women, diabetic, smoker, psoriasis, lupus or other autoimmune diseases, patient with a clear history of keloids or poor wound healing. This study will exclude dermatofibroma lesions on the face and genitals.
- healthy Volunteers
- false
- maximum Age
- 65 Years
- minimum Age
- 18 Years
- sex
- ALL
- std Ages
- ADULT
- OLDER_ADULT
Treatment arms and interventions
- arm Groups
- description
- All subjects will be treated with the laser at week 0 and week 4. Only assessors will be blinded and rate the dermatofibromas in photographs, they will not know which photos were taken pre-treatment vs. post-treatment to determine efficacy.
- intervention Names
- Device: 1540 nanometer Erbium glass laser
- label
- All Subjects
- type
- EXPERIMENTAL
- interventions
- arm Group Labels
- All Subjects
- description
- Subjects will receive laser treatment by dermatologist at week 0 and week 4.
- name
- 1540 nanometer Erbium glass laser
- type
- DEVICE
Study design
- allocation
- NA
- intervention Model
- SINGLE_GROUP
- intervention Model Description
- All subjects will have their dermatofibromas treated with the laser at week 0, and week 4. Blinded outcome assessors will rate photos (pre-treatment and follow-up visit 1) to determine efficacy.
- masking Info
- masking
- NONE
- masking Description
- Outcome assessors are masked and will not know which photos are pre-treatment or follow-up visit 1, however, they do know that all subjects received treatment at some point. They will rate the dermatofibromas to determine efficacy. However, there is only one arm of this study. All patients are receiving the same treatment. Outcomes assessors are the only masked roles.
- primary Purpose
- TREATMENT
Enrollment
- count
- 37
- type
- ACTUAL
Registered outcome plans (not posted results)
- primary Outcomes
- description
- Patient reported assessment scale of pain, itch, color, and texture. Each element (pain, itch, color, and texture) is graded on a 1-10 scale. The lowest score is '1', which corresponds to the situation of normal skin/no symptoms (i.e. not different in color, not different in texture, no itching, no pain). Score 10 equals the largest difference from normal skin (i.e. severely painful, severely itchy, vert different color, very different texture).
- measure
- Modified Patient and Observer Scar Assessment Scale Color Component Comparing Change From Baseline to Week 12.
- time Frame
- 12 weeks
- secondary Outcomes
- description
- Patient reported assessment scale of pain, itch, color, and texture. Each element (pain, itch, color, and texture) is graded on a 1-10 scale. The lowest score is '1', which corresponds to the situation of normal skin/no symptoms (i.e. not different in color, not different in texture, no itching, no pain). Score 10 equals the largest difference from normal skin (i.e. severely painful, severely itchy, vert different color, very different texture).
- measure
- Modified Patient and Observer Scar Assessment Scale Itch Component Comparing Change From Baseline to Week 12.
- time Frame
- 12 Weeks
- description
- Patient reported assessment scale of pain, itch, color, and texture. Each element (pain, itch, color, and texture) is graded on a 1-10 scale. The lowest score is '1', which corresponds to the situation of normal skin/no symptoms (i.e. not different in color, not different in texture, no itching, no pain). Score 10 equals the largest difference from normal skin (i.e. severely painful, severely itchy, vert different color, very different texture).
- measure
- Modified Patient and Observer Scar Assessment Scale Texture Component Comparing Change From Baseline to Week 12.
- time Frame
- 12 Weeks
- description
- Patient reported assessment scale of pain, itch, color, and texture. Each element (pain, itch, color, and texture) is graded on a 1-10 scale. The lowest score is '1', which corresponds to the situation of normal skin/no symptoms (i.e. not different in color, not different in texture, no itching, no pain). Score 10 equals the largest difference from normal skin (i.e. severely painful, severely itchy, vert different color, very different texture).
- measure
- Modified Patient and Observer Scar Assessment Scale Pain Component Comparing Change From Baseline to Week 12.
- time Frame
- 12 weeks
Full study description
- brief Summary
- This study is to find a more effective treatment for itchy, painful or unsightly dermatofibromas, that will improve symptoms of itch and/or pain and/or improve the appearance of dermatofibromas. This is an open-label study where subjects will receive a laser treatment at week 0, and week 4, and then 2 additional follow-up visits. Photographs will be taken at each visit and rated by blinded reviewers after the study to determine efficacy.
- detailed Description
- The main objective of this study is to find a more effective treatment for itchy, painful or unsightly dermatofibromas, that will improve symptoms of itch and/or pain and/or improve the appearance of dermatofibromas. A secondary objective of this study is to better understand the 1540 nanometer Erbium glass laser and its impact on the skin. This is an open-label study where subjects will receive a laser treatment at week 0, and week 4, and then have 2 additional follow-up visits (no laser treatment at these visits). Photographs will be taken at each visit and photographs from pre-treatment and follow-up 1 (week 8) will rated by blinded reviewers after the study to determine efficacy.
Source references
Source notices and limitations
Discovery and provenance
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Preserved source evidence · Not medical advice