Trial · NCT05010421
Laser vs Clobetasol for Lichen Sclerosus
NCT05010421, Phase 3, Completed, Ruhr University of Bochum
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Laser vs Clobetasol for Lichen Sclerosus. Trials, record NCT05010421. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05010421
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Laser vs Clobetasol for Lichen Sclerosus
- NCT number
- NCT05010421
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 246 participants, actual
- Lead sponsor
- Ruhr University of Bochum
- Conditions
- Lichen Sclerosus
- Interventions
- Clobetasol 0.05% Emollient Top Cream, Non-ablative CO2 Laser
- First posted
- 2021-08-18
- Last updated
- 2025-12-04
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Vulvar burning, itching, and pain | from date of randomization until 12 weeks | Summary score of three symptoms of LS, i.e. vulvar burning, itching, and pain (11-item VAS each). Higher values mean worse outcome. |
| Secondary | Efficacy - Physician-scored rate of visual improvement (0-10) | 3 months after treatment start | 11-item VAS; higher values mean better outcome. |
| Secondary | Safety - Number and severity of side effects | 0-7 days after laser treatment (laser group); as well as throughout study duration (3 months; both groups) | Side effects (perioperative and postoperative complications up to 7 days) including but not limited to bleeding, infection, wound breakdown, unscheduled re-admission, and local pain necessitating systemic analgesia. |
| Secondary | Subjective overall improvement (0-10) | 3 months after treatment start | The patient's subjective judgement of improvement (11-item VAS); higher values mean better outcome. |
| Secondary | Vulval Disease Quality of life Index (0-45) | Throughout study completion (3 months; for a total of 4 or 5 assessments, depending on group assignment) | Quality of life assessed before the start of therapy, after every treatment course (laser group; days 0, 14, 28, 42) or after 2 and 6 weeks (clobetasol group; days 0, 14, 42), and after 3 months (both groups) using a standardized, validated questionnaire (VDQI, Vulval Disease Quality of life Index). Lower score mean better outcome. |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers7
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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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.
GET https://conductscience.org/api/trials/v1/NCT05010421
GET https://conductscience.org/api/trials/v1/NCT05010421/registered