Trial · NCT02573883
Clobetasol Propionate Versus Fractionated Carbon Dioxide Laser for the Treatment of Lichen Sclerosus
NCT02573883, Phase 3, Completed, Medstar Health Research Institute; results first posted 2021-10-12
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Clobetasol Propionate Versus Fractionated Carbon Dioxide Laser for the Treatment of Lichen Sclerosus. Trials, record NCT02573883. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02573883
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Clobetasol Propionate Versus Fractionated Carbon Dioxide Laser for the Treatment of Lichen Sclerosus
- NCT number
- NCT02573883
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 52 participants, actual
- Lead sponsor
- Medstar Health Research Institute
- Conditions
- Vulvar Lichen Sclerosus
- Interventions
- Fractionated Carbon Dioxide Laser, Clobetasol Propionate 0.05% ointment
- First posted
- 2015-10-12
- Last updated
- 2021-10-12
- Results first posted
- 2021-10-12
- Limitations and caveats
The study was unblinded for patients and evaluators and only performed at a single center. The steroid group had more non-compliant patients (25% vs 4%). We limited our investigation to only postmenopausal women Further research using placebo and sham lasers for treatment blinding is needed. Patients previously using topical vaginal estrogen were continued on prior treatment, groups were not stratified based on estrogen exposure, however there where equal numbers between groups.
Source ClinicalTrials.gov
Registered outcomes15
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in SkinDEX-29 Score | Change from baseline score to score at six months | The Skindex-29 is a validated questionnaire for assessing acute dermatologic symptoms over a 4-week period. The Skindex-29 is a 29 question version of the original SkinDEX questionnaire. Total numeric score is reported ranging from 0-100. Scores reported as a change between six months and baseline with more negative scores indicating greater improvement in symptoms (better outcome). |
| Secondary | Change in Subjective Vulvovaginal Symptoms Questionnaire (VSQ) | Baseline to six months | Subjective measure of vulvar symptoms of itching, burning, dyspareunia of Lichen Sclerosus. VSQ is a 21-item instrument and scores range from 0 to 20 with increased scores indicating increased vulvovaginal symptom bother. The change in VSQ is reported with more negative scores indicating greater improvement. |
| Secondary | Change in Subjective Vulvovaginal Symptoms Questionnaire (VSQ) | Six month to one year after treatment | Subjective measure of vulvar symptoms of itching, burning, dyspareunia of Lichen Sclerosus. VSQ is a 21-item instrument and scores range from 0 to 20 with increased scores indicating increased vulvovaginal symptom bother. The change in VSQ is reported with more negative scores indicating greater improvement. |
| Secondary | Number of Participants Considered Satisfied as Assessed by Health Related Quality of Life (HRQOL) Score | Six months from treatment | Patient global impression of satisfaction total score on visual analog scale (very satisfied or satisfied) ranging from 1-5 with higher scores indicating greater satisfaction. |
| Secondary | Number of Participants Considered Satisfied as Assessed by Health Related Quality of Life (HRQOL) Score | 1 year from treatment | Patient global impression of satisfaction total score on visual analog scale (very satisfied or satisfied) ranging from 1-5 with higher scores indicating greater satisfaction. |
| Secondary | Change Vaginal Health Index (VHI) Score | Baseline to 6 months after treatment | The Vaginal Health Index is a five item scale with scores ranging from 5-25 with lower scores indicating greater urogenital atrophy. The change in VHI is express with more negative scores indicating greater improvement between study time points. |
| Secondary | Change Vaginal Health Index (VHI) Score | Six month to one year after treatment | The Vaginal Health Index is a five item scale with scores ranging from 5-25 with lower scores indicating greater urogenital atrophy. The change in VHI is express with more negative scores indicating greater improvement between study time points. |
| Secondary | Change Vulvar Symptom Visual Analog Scale (VAS) Score | Baseline to 6 months after treatment | Patient subjective scale of symptoms of Lichen Sclerosus. Each item scaled 0-10 with greater severity of symptoms indicated by higher score. Results expressed as change with more negative values indicating greater improvement. |
| Secondary | Change Vulvar Symptom Visual Analog Scale (VAS) Score | Six months to one year after treatment | Patient subjective scale of symptoms of Lichen Sclerosus. Each item scaled 0-10 with greater severity of symptoms indicated by higher score. Results expressed as change with more negative values indicating greater improvement in symptoms (better outcome). |
| Secondary | Change SkinDEX-29 Score | Six months to one year from treatment | The Skindex-29 is a validated questionnaire for assessing acute dermatologic symptoms over a 4-week period. The Skindex-29 is a 29 question version of the original SkinDEX questionnaire. Total numeric score is reported ranging from 0-100. Scores reported as a change between six months and baseline with more negative scores indicating greater improvement. |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 registered outcomesOutcomes15
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change in SkinDEX-29 Score | Change from baseline score to score at six months | score on a scale | MEAN | |
| SECONDARY | Change in Subjective Vulvovaginal Symptoms Questionnaire (VSQ) | Baseline to six months | score on a scale | MEAN | |
| SECONDARY | Change in Subjective Vulvovaginal Symptoms Questionnaire (VSQ) | Six month to one year after treatment | score on a scale | MEAN | |
| SECONDARY | Number of Participants Considered Satisfied as Assessed by Health Related Quality of Life (HRQOL) Score | Six months from treatment | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Number of Participants Considered Satisfied as Assessed by Health Related Quality of Life (HRQOL) Score | 1 year from treatment | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Change Vaginal Health Index (VHI) Score | Baseline to 6 months after treatment | score on a scale | MEAN | |
| SECONDARY | Change Vaginal Health Index (VHI) Score | Six month to one year after treatment | score on a scale | MEAN | |
| SECONDARY | Change Vulvar Symptom Visual Analog Scale (VAS) Score | Baseline to 6 months after treatment | score on a scale | MEAN | |
| SECONDARY | Change Vulvar Symptom Visual Analog Scale (VAS) Score | Six months to one year after treatment | score on a scale | MEAN | |
| SECONDARY | Change SkinDEX-29 Score | Six months to one year from treatment | score on a scale | MEAN |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 outcomesResults by group128
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change in SkinDEX-29 Score | Fractionated Carbon Dioxide Laser | -16.83 | Standard Deviation 18.09 | score on a scale | |
| Change in SkinDEX-29 Score | Clobetasol Propionate | -5.92 | Standard Deviation 5.81 | score on a scale | |
| Change in Subjective Vulvovaginal Symptoms Questionnaire (VSQ) | Fractionated Carbon Dioxide Laser | -3.92 | Standard Deviation 4.12 | score on a scale | |
| Change in Subjective Vulvovaginal Symptoms Questionnaire (VSQ) | Clobetasol Propionate | -0.58 | Standard Deviation 5.11 | score on a scale | |
| Change in Subjective Vulvovaginal Symptoms Questionnaire (VSQ) | Fractionated Carbon Dioxide Laser- No Crossover | 0.44 | Standard Deviation 4.43 | score on a scale | |
| Change in Subjective Vulvovaginal Symptoms Questionnaire (VSQ) | Clobetasol Propionate- No Crossover | 0.3 | Standard Deviation 2.41 | score on a scale | |
| Change in Subjective Vulvovaginal Symptoms Questionnaire (VSQ) | Clobetasol Propionate to Laser Crossover | -1.82 | Standard Deviation 3.66 | score on a scale | |
| Change in Subjective Vulvovaginal Symptoms Questionnaire (VSQ) | Fractionated Carbon Dioxide Laser to Clobetasol Crossover | -2.9 | Standard Deviation 3.98 | score on a scale | |
| Number of Participants Considered Satisfied as Assessed by Health Related Quality of Life (HRQOL) Score | Fractionated Carbon Dioxide Laser | 21 | Participants | ||
| Number of Participants Considered Satisfied as Assessed by Health Related Quality of Life (HRQOL) Score | Clobetasol Propionate | 9 | Participants |
1 to 10 of 128Source ClinicalTrials.gov
See all 128 results by groupParticipant flow24
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Six Month Follow Up | STARTED | Clobetasol Propionate- No Crossover | 25 | |
| Six Month Follow Up | STARTED | Fractionated Carbon Dioxide Laser- No Crossover | 27 | |
| Six Month Follow Up | STARTED | Clobetasol Propionate to Laser Crossover | 0 | |
| Six Month Follow Up | STARTED | Fractionated Carbon Dioxide Laser to Clobetasol Crossover | 0 | |
| Six Month Follow Up | COMPLETED | Clobetasol Propionate- No Crossover | 24 | |
| Six Month Follow Up | COMPLETED | Fractionated Carbon Dioxide Laser- No Crossover | 27 | |
| Six Month Follow Up | COMPLETED | Clobetasol Propionate to Laser Crossover | 0 | |
| Six Month Follow Up | COMPLETED | Fractionated Carbon Dioxide Laser to Clobetasol Crossover | 0 | |
| Six Month Follow Up | NOT COMPLETED | Clobetasol Propionate- No Crossover | 1 | |
| Six Month Follow Up | NOT COMPLETED | Fractionated Carbon Dioxide Laser- No Crossover | 0 |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 participant flowAdverse events12
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | minor burning and blistering at treatment site | Reproductive system and breast disorders | Clobetasol Propionate- 0-6 Months | 0 | 27 | 0 |
| other | minor burning and blistering at treatment site | Reproductive system and breast disorders | Fractionated Carbon Dioxide Laser- 0-6 Months | 1 | 24 | 1 |
| other | minor burning and blistering at treatment site | Reproductive system and breast disorders | Clobetasol Propionate to Laser Crossover 6-12 Months | 0 | 11 | 0 |
| other | minor burning and blistering at treatment site | Reproductive system and breast disorders | Fractionated Carbon Dioxide Laser to Clobetasol Crossover 6-12 Months | 0 | 10 | 0 |
| other | minor burning and blistering at treatment site | Reproductive system and breast disorders | Clobetasol Propionate - No Crossover 6-12 Months | 0 | 11 | 0 |
| other | minor burning and blistering at treatment site | Reproductive system and breast disorders | Fractionated Carbon Dioxide Laser- No Crossover 6-12 Months | 0 | 16 | 0 |
| other | Activation Genital Herpes | Reproductive system and breast disorders | Clobetasol Propionate- 0-6 Months | 1 | 27 | 1 |
| other | Activation Genital Herpes | Reproductive system and breast disorders | Fractionated Carbon Dioxide Laser- 0-6 Months | 0 | 24 | 0 |
| other | Activation Genital Herpes | Reproductive system and breast disorders | Clobetasol Propionate to Laser Crossover 6-12 Months | 0 | 11 | 0 |
| other | Activation Genital Herpes | Reproductive system and breast disorders | Fractionated Carbon Dioxide Laser to Clobetasol Crossover 6-12 Months | 0 | 10 | 0 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse eventsAdverse event totals18
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Clobetasol Propionate- 0-6 Months | 0 | 27 |
| Total, all-cause mortality | Fractionated Carbon Dioxide Laser- 0-6 Months | 0 | 24 |
| Total, all-cause mortality | Clobetasol Propionate to Laser Crossover 6-12 Months | 0 | 11 |
| Total, all-cause mortality | Fractionated Carbon Dioxide Laser to Clobetasol Crossover 6-12 Months | 0 | 10 |
| Total, all-cause mortality | Clobetasol Propionate - No Crossover 6-12 Months | 0 | 11 |
| Total, all-cause mortality | Fractionated Carbon Dioxide Laser- No Crossover 6-12 Months | 0 | 16 |
| Total, other adverse events | Clobetasol Propionate- 0-6 Months | 1 | 27 |
| Total, other adverse events | Fractionated Carbon Dioxide Laser- 0-6 Months | 1 | 24 |
| Total, other adverse events | Clobetasol Propionate to Laser Crossover 6-12 Months | 0 | 11 |
| Total, other adverse events | Fractionated Carbon Dioxide Laser to Clobetasol Crossover 6-12 Months | 0 | 10 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 adverse event totalsPapers4
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Fractionated Carbon Dioxide Laser vs Clobetasol Propionate: Number of Patients With Adverse Outcomes | Trial comparisons |
| Fractionated Carbon Dioxide Laser vs Clobetasol Propionate: Number of Participants Considered Satisfied as Assessed by Health Related Quality of Life (HRQOL) Score | Trial comparisons |
| Fractionated Carbon Dioxide Laser vs Clobetasol Propionate: Number of Patients With Adverse Outcomes | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
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GET https://conductscience.org/api/trials/v1/NCT02573883/results?page=2