Trial · NCT07077902
A Study for Evaluating Safety & Efficacy of Topical Roflumilast 0.3% Foam in Hidradenitis Suppurativa
NCT07077902, Phase 2, Completed, Tulane University
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Study for Evaluating Safety & Efficacy of Topical Roflumilast 0.3% Foam in Hidradenitis Suppurativa. Trials, record NCT07077902. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07077902
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study for Evaluating Safety & Efficacy of Topical Roflumilast 0.3% Foam in Hidradenitis Suppurativa
- NCT number
- NCT07077902
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 10 participants, actual
- Lead sponsor
- Tulane University
- Conditions
- Hidradenitis Suppurativa
- Interventions
- Topical roflumilast 0.3% foam
- First posted
- 2025-07-22
- Last updated
- 2026-10-09
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Measure the change in gene expression profile at week 16 of using topical roflumilast vs baseline | Baseline, 16 weeks | The investigators will perform gene expression profiling (GEP) using RNA sequencing on tape strips collected before and after treatment with topical roflumilast. Sixteen tape strips from lesional skin will be performed before treatment with topical roflumilast and after 4 months of treatment for gene expression profiling. |
| Secondary | Measure the overall response rate of topical roflumilast when applied to the skin of HS patients. | Baseline, 4 months | The efficacy assessment will be based on overall response rate (ORR) of topical roflumilast in patients with HS at 4 months. The ORR will be measured using the change in total abscess and inflammatory nodule count (AN count) at week 16 vs number of active lesions at baseline. Change from baseline will be calculated as the week 16 value minus the baseline value. |
| Secondary | Measure the change in quality of life for HS patients applying topical roflumilast to their skin | Baseline, 1 month, 4 months | The investigators will assess the patients' quality of life using Dermatology Life Quality Index (DLQI) score ranging from (0-30) where 0 has no effect on quality of life and 30 has an extremely large effect on quality of life. DLQI will be measured at months 0, 1 and 4 months. The minimal clinically important difference on the DLQI score is a change of 4. |
| Secondary | Measure the change in numerical pain score for HS patients applying topical roflumilast to their skin | Baseline, 1 month, 4 months | The investigators will assess the skin pain response using Numerical Rating Scale (NRS30). NRS an 11-point scale ranging from 0 (no pain) to 10 (worst pain imaginable). NRS will be measured at months 0, 1 and 4 months. The minimal clinically meaningful important difference on the NRS score is ≥30% reduction and ≥2-point reduction in skin pain from baseline. |
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.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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/NCT07077902
GET https://conductscience.org/api/trials/v1/NCT07077902/registered