NCT04148651 · OUTCOME
Average Scores for VLS Clinical Signs Present At Baseline, 3, 6 and 12 Months After the Last Treatment as Assessed by the Investigators
The CO2RE® System for Vulvar Lichen Sclerosus · Source last updated 2022-03-22
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEAN
- Unit
- score on a scale
- Interval / dispersion
- Standard Deviation
- Time frame
- At Baseline, 3, 6 and 12 months after the final treatment
What was measured
Each clinical sign of VLS (loss of elasticity, sclerosis, lichenification, whitening, parchment-like skin, fissures, extent of the disease, erosions, ulcerations, hyperkeratosis, excoriation, telangiectasia) was assessed separately by the investigator, using a 4-point scale (0=not present, 1=mild, 2=moderate or 3=severe) for each subject at baseline and follow-ups. For those clinical signs present at baseline (baseline score \>0 on severity scale), an average severity grade was calculated at each endpoint to evaluate overall treatment outcome, as follows:
Average severity grade = Sum of all severity grades (0, 1, 2, or 3) for each individual parameter of clinical signs present at baseline for each subject / Number of grades
A lower average score means better outcome.
Analysis population: At Baseline, 12 subjects had 96 clinical signs present (score \>0). One subject missed the 12-month follow-up, one subject missed the 3- and 12-month follow-ups and one subject missed the 6-month follow-up. Hence, at 3- and 6-month follow-up visits 11 subjects were assessed (with 89 clinical signs averaged for each visit) and at the 12-month follow-up visit 10 subjects were assessed (with 79 clinical signs averaged).
Groups in this outcome
CO2RE® Treatment
All eligible subjects that underwent up to 5 treatments at 4±1-week intervals to the vulva with a fractional CO2 laser and maintained the protocol regimen.
The CO2RE® System: The CO2RE® system is a fractional CO2 laser that is FDA-cleared under a 510(k) K181523 for laser incision, excision, ablation and/or vaporization and of soft tissue in gynecology (GYN).
Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.
Analysis denominator · Participants
| Group | Source count |
|---|
| CO2RE® Treatment | 12 |
|---|
Analysis denominator · Clinical signs
| Group | Source count |
|---|
| CO2RE® Treatment | 96 |
|---|
Reported measurements
Average score of clinical signs at Baseline
Analysis denominator · Participants
| Group | Source count |
|---|
| CO2RE® Treatment | 12 |
|---|
Analysis denominator · Clinical signs
| Group | Source count |
|---|
| CO2RE® Treatment | 96 |
|---|
Values in score on a scale · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| CO2RE® Treatment | 1.85 | 0.73 | Not reported | Not reported | Not reported |
|---|
Average score of clinical signs at 3-months follow-up visit
Analysis denominator · Participants
| Group | Source count |
|---|
| CO2RE® Treatment | 11 |
|---|
Analysis denominator · Clinical signs
| Group | Source count |
|---|
| CO2RE® Treatment | 89 |
|---|
Values in score on a scale · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| CO2RE® Treatment | 0.65 | 0.74 | Not reported | Not reported | Not reported |
|---|
Average score of clinical signs at 6-months follow-up visit
Analysis denominator · Participants
| Group | Source count |
|---|
| CO2RE® Treatment | 11 |
|---|
Analysis denominator · Clinical signs
| Group | Source count |
|---|
| CO2RE® Treatment | 89 |
|---|
Values in score on a scale · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| CO2RE® Treatment | 0.65 | 0.76 | Not reported | Not reported | Not reported |
|---|
Average score of clinical signs at 12-months follow-up visits
Analysis denominator · Participants
| Group | Source count |
|---|
| CO2RE® Treatment | 10 |
|---|
Analysis denominator · Clinical signs
| Group | Source count |
|---|
| CO2RE® Treatment | 79 |
|---|
Values in score on a scale · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| CO2RE® Treatment | 0.73 | 0.83 | Not reported | Not reported | Not reported |
|---|
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 0.73
- value
- 1.85
- denoms
- units
- Participants
- units
- Clinical signs
- title
- Average score of clinical signs at Baseline
- categories
- measurements
- group Id
- OG000
- spread
- 0.74
- value
- 0.65
- denoms
- units
- Participants
- units
- Clinical signs
- title
- Average score of clinical signs at 3-months follow-up visit
- categories
- measurements
- group Id
- OG000
- spread
- 0.76
- value
- 0.65
- denoms
- units
- Participants
- units
- Clinical signs
- title
- Average score of clinical signs at 6-months follow-up visit
- categories
- measurements
- group Id
- OG000
- spread
- 0.83
- value
- 0.73
- denoms
- units
- Participants
- units
- Clinical signs
- title
- Average score of clinical signs at 12-months follow-up visits
- denom Units Selected
- Clinical signs
- denoms
- units
- Participants
- units
- Clinical signs
- description
- Each clinical sign of VLS (loss of elasticity, sclerosis, lichenification, whitening, parchment-like skin, fissures, extent of the disease, erosions, ulcerations, hyperkeratosis, excoriation, telangiectasia) was assessed separately by the investigator, using a 4-point scale (0=not present, 1=mild, 2=moderate or 3=severe) for each subject at baseline and follow-ups. For those clinical signs present at baseline (baseline score \>0 on severity scale), an average severity grade was calculated at each endpoint to evaluate overall treatment outcome, as follows:
Average severity grade = Sum of all severity grades (0, 1, 2, or 3) for each individual parameter of clinical signs present at baseline for each subject / Number of grades
A lower average score means better outcome.
- dispersion Type
- Standard Deviation
- groups
- description
- All eligible subjects that underwent up to 5 treatments at 4±1-week intervals to the vulva with a fractional CO2 laser and maintained the protocol regimen.
The CO2RE® System: The CO2RE® system is a fractional CO2 laser that is FDA-cleared under a 510(k) K181523 for laser incision, excision, ablation and/or vaporization and of soft tissue in gynecology (GYN).
- id
- OG000
- title
- CO2RE® Treatment
- param Type
- MEAN
- population Description
- At Baseline, 12 subjects had 96 clinical signs present (score \>0). One subject missed the 12-month follow-up, one subject missed the 3- and 12-month follow-ups and one subject missed the 6-month follow-up. Hence, at 3- and 6-month follow-up visits 11 subjects were assessed (with 89 clinical signs averaged for each visit) and at the 12-month follow-up visit 10 subjects were assessed (with 79 clinical signs averaged).
- reporting Status
- POSTED
- time Frame
- At Baseline, 3, 6 and 12 months after the final treatment
- title
- Average Scores for VLS Clinical Signs Present At Baseline, 3, 6 and 12 Months After the Last Treatment as Assessed by the Investigators
- type
- PRIMARY
- type Units Analyzed
- Clinical signs
- unit Of Measure
- score on a scale
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Preserved source evidence · Not medical advice
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