Trial · NCT07543640
EFFICACY OF ROFLUMILAST IN THE TREATMENT OF FLEXURAL AND/OR GENITAL PSORIASIS: A RANDOMIZED CONTROLLED TRIAL.
NCT07543640, Phase 2, Not yet recruiting, Eman Raafat Said
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. EFFICACY OF ROFLUMILAST IN THE TREATMENT OF FLEXURAL AND/OR GENITAL PSORIASIS: A RANDOMIZED CONTROLLED TRIAL. Trials, record NCT07543640. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07543640
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- EFFICACY OF ROFLUMILAST IN THE TREATMENT OF FLEXURAL AND/OR GENITAL PSORIASIS: A RANDOMIZED CONTROLLED TRIAL.
- NCT number
- NCT07543640
- Status
- Not yet recruiting
- Phases
- Phase 2
- Enrollment
- 56 participants, estimated
- Lead sponsor
- Eman Raafat Said
- Conditions
- Flexural Psoriasis (Also Known as Inverse or Intertriginous Psoriasis) and Genital Psoriasis
- Interventions
- Methotrexate, Roflumilast 500 Mcg Oral Tablet
- First posted
- 2026-04-22
- Last updated
- 2026-04-22
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Clinical Success at flexural (I-IGA 0/1) and/or genital (sPGA-G 0/1) psoriasis | week 16 | The proportion of patients achieving a score of 0 (clear) or 1 (almost clear) with at least a 2-point improvement from baseline at the specific sensitive sites. This is assessed using the Investigator's Global Assessment for Flexural Psoriasis (I-IGA) for skin folds and the static Physician's Global Assessment of Genitalia (sPGA-G) for genital involvement. |
| Secondary | Global Skin Clearance (PASI Responses) | Week 16 | The proportion of patients achieving clinically significant reductions in disease severity as measured by the Psoriasis Area and Severity Index (PASI), specifically the PASI 75, PASI 90, and PASI 100 benchmarks (representing ≥75%, ≥90%, and 100% improvement from baseline, respectively) |
| Secondary | Quality of Life Improvement (DLQI 0/1) | week 16 | The proportion of patients achieving a Dermatology Life Quality Index (DLQI) score of 0 or 1, signifying that the skin condition has no impact at all on the patient's overall quality of life. |
| Secondary | Itch Relief (Itch-NRS) | week 16 | The proportion of patients achieving a clinically meaningful ≥4-point reduction from baseline in the Itch Numeric Rating Scale (Itch-NRS) or reaching an absolute score of 0 or 1 (no itch or minimal itch) |
| Secondary | Safety and Tolerability (Adverse Events) | Throughout the 16-week treatment period and during the follow-up period (at least 3 months) | The incidence, nature, and severity of treatment-related adverse events (AEs) and serious adverse events (SAEs) documented in both treatment arms. This includes monitoring for dropouts specifically due to drug-related side effects. |
| Secondary | Body Surface Area (BSA) Reduction | week 16 | The proportion of patients achieving an absolute Body Surface Area (BSA) involvement of ≤1% or the mean percentage change in BSA from baseline to the end of the study. |
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/NCT07543640
GET https://conductscience.org/api/trials/v1/NCT07543640/registered