NCT04148651 · OUTCOME
Average Scores for VLS Architectural Changes Present At Baseline and at 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
- Baseline, 3 , 6 and 12 months after the final treatment
What was measured
Each architectural change of VLS (labial fusion, clitoral hood fusion, narrowing of the introitus, anterior changes, perianal involvement, formation of posterior commissure bands) 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 architectural changes 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 architectural changes present at baseline for each subject / Number of grades
A lower average score means better outcome.
Analysis population: At Baseline, 12 patients had 55 architectural changes 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 the 3- and 6-month follow-ups, 11 subjects were assessed (with 51 architectural changes averaged for each visit) and at the 12-month follow-up 10 subjects were assessed (with 49 architectural changes 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 · Architectural Changes
| Group | Source count |
|---|
| CO2RE® Treatment | 55 |
|---|
Reported measurements
Average score of architectural changes at Baseline
Analysis denominator · Participants
| Group | Source count |
|---|
| CO2RE® Treatment | 12 |
|---|
Analysis denominator · Architectural Changes
| Group | Source count |
|---|
| CO2RE® Treatment | 55 |
|---|
Values in score on a scale · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| CO2RE® Treatment | 2.18 | 0.72 | Not reported | Not reported | Not reported |
|---|
Average score of architectural changes at 3-month follow-up
Analysis denominator · Participants
| Group | Source count |
|---|
| CO2RE® Treatment | 11 |
|---|
Analysis denominator · Architectural Changes
| Group | Source count |
|---|
| CO2RE® Treatment | 51 |
|---|
Values in score on a scale · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| CO2RE® Treatment | 1.10 | 0.90 | Not reported | Not reported | Not reported |
|---|
Average score of architectural changes at 6-month follow-up
Analysis denominator · Participants
| Group | Source count |
|---|
| CO2RE® Treatment | 11 |
|---|
Analysis denominator · Architectural Changes
| Group | Source count |
|---|
| CO2RE® Treatment | 51 |
|---|
Values in score on a scale · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| CO2RE® Treatment | 1.04 | 0.87 | Not reported | Not reported | Not reported |
|---|
Average score of architectural changes at 12-month follow-up
Analysis denominator · Participants
| Group | Source count |
|---|
| CO2RE® Treatment | 10 |
|---|
Analysis denominator · Architectural Changes
| Group | Source count |
|---|
| CO2RE® Treatment | 49 |
|---|
Values in score on a scale · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| CO2RE® Treatment | 1.08 | 0.91 | Not reported | Not reported | Not reported |
|---|
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 0.72
- value
- 2.18
- denoms
- units
- Participants
- units
- Architectural Changes
- title
- Average score of architectural changes at Baseline
- categories
- measurements
- group Id
- OG000
- spread
- 0.90
- value
- 1.10
- denoms
- units
- Participants
- units
- Architectural Changes
- title
- Average score of architectural changes at 3-month follow-up
- categories
- measurements
- group Id
- OG000
- spread
- 0.87
- value
- 1.04
- denoms
- units
- Participants
- units
- Architectural Changes
- title
- Average score of architectural changes at 6-month follow-up
- categories
- measurements
- group Id
- OG000
- spread
- 0.91
- value
- 1.08
- denoms
- units
- Participants
- units
- Architectural Changes
- title
- Average score of architectural changes at 12-month follow-up
- denom Units Selected
- Architectural Changes
- denoms
- units
- Participants
- units
- Architectural Changes
- description
- Each architectural change of VLS (labial fusion, clitoral hood fusion, narrowing of the introitus, anterior changes, perianal involvement, formation of posterior commissure bands) 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 architectural changes 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 architectural changes 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 patients had 55 architectural changes 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 the 3- and 6-month follow-ups, 11 subjects were assessed (with 51 architectural changes averaged for each visit) and at the 12-month follow-up 10 subjects were assessed (with 49 architectural changes averaged).
- reporting Status
- POSTED
- time Frame
- Baseline, 3 , 6 and 12 months after the final treatment
- title
- Average Scores for VLS Architectural Changes Present At Baseline and at 3, 6 and 12 Months After the Last Treatment as Assessed by the Investigators
- type
- PRIMARY
- type Units Analyzed
- Architectural Changes
- unit Of Measure
- score on a scale
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Preserved source evidence · Not medical advice
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