Trial · NCT07892339
Efficacy of Crisaborole 2% Ointment Versus Tacrolimus 0.1% Ointment in the Treatment of Intertriginous and/or Anogenital Psoriasis.
NCT07892339, Phase 3, Not yet recruiting, Cairo University
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Efficacy of Crisaborole 2% Ointment Versus Tacrolimus 0.1% Ointment in the Treatment of Intertriginous and/or Anogenital Psoriasis. Trials, record NCT07892339. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07892339
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy of Crisaborole 2% Ointment Versus Tacrolimus 0.1% Ointment in the Treatment of Intertriginous and/or Anogenital Psoriasis.
- NCT number
- NCT07892339
- Status
- Not yet recruiting
- Phases
- Phase 3
- Enrollment
- 40 participants, estimated
- Lead sponsor
- Cairo University
- Conditions
- Psoriasis, Psoriasis Genital
- Interventions
- Crisaborole 2% topical ointment, tacrolimus ointment 0.1%
- First posted
- 2026-10-23
- Last updated
- 2026-10-27
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Target Lesion Severity Score (TLSS) | From enrollment to the end of treatment at 6 weeks and at 10 weeks (4 weeks after treatment cessation). | The TLSS will be used to assess the clinical severity of a representative psoriatic lesion during the study period. This score is commonly employed in clinical trials evaluating topical therapies for localized psoriasis because it allows detailed assessment of changes within a selected target plaque over time. The TLSS evaluates three principal clinical signs of psoriasis: erythema, scaling, and plaque elevation/induration. Each parameter is graded separately on a 5-point scale ranging from 0 to 4, where 0 indicates absence of the sign, 1 indicates mild involvement, 2 moderate involvement, 3 marked involvement, and 4 very marked or severe involvement. The total TLSS is calculated by summing the individual scores, resulting in a total score ranging from 0 to 12, with higher scores reflecting greater lesion severity. |
| Primary | Static Physician's Global Assessment (sPGA) | From enrollment to the end of treatment at 6 weeks and at 10 weeks (4 weeks after treatment cessation). | The sPGA is a validated investigator-based assessment tool that rates disease severity at a single point in time based on plaque characteristics including erythema, scaling, and induration. Scores are typically graded on a 5-point scale ranging from 0 (clear) to 4 (severe disease). The static Physician's Global Assessment (sPGA) will be used to evaluate the overall clinical severity of psoriasis lesions throughout the study. |
| Primary | Dynamic Physician Global Assessment (dPGA) | From enrollment to the end of treatment at 6 weeks and at 10 weeks (4 weeks after treatment cessation). | Dynamic PGA provides a global assessment of the change in psoriasis severity between baseline and the end of treatment. The change will be assessed by comparing standardized clinical photographs that will be obtained at baseline with those that will be obtained at week 6 by a blinded investigator. The dynamic PGA will be scored on an 11-point scale ranging from -5 to +5, with positive scores indicating improvement, zero indicating no meaningful change, and negative scores indicating deterioration |
| Secondary | Visual Analogue Scale (VAS) for Pain and Pruritus | From enrollment to the end of treatment at 6 weeks and at 10 weeks (4 weeks after treatment cessation). | Subjective localized symptoms, including pain, burning, and itching, will be assessed using a standardized VAS. |
| Secondary | Patient Satisfaction Score | At the end of treatment at 6 weeks and at 10 weeks (4 weeks after treatment cessation). | Subjective overall satisfaction with the assigned topical therapy will be recorded from 0 (unsatisfied) to 10 (completely satisfied) via a standardized scale. |
| Secondary | Psoriasis Area and Severity Index (PASI) | From enrollment to the end of treatment at 6 weeks and at 10 weeks (4 weeks after treatment cessation). | The PASI is the most widely used clinician-rated instrument for assessing the severity and extent of psoriasis. It combines the evaluation of lesion severity and the percentage of affected body surface area into a single composite score. The body is divided into four regions: head (10%), upper limbs (20%), trunk (30%), and lower limbs (40%). For each region, three clinical signs of psoriasis-erythema (redness), induration (thickness), and desquamation (scaling)-are rated on a 5-point scale from 0 (none) to 4 (severe); The area affected in each region is scored from 0 (0%) to 6 (90-100%). Regional scores are then weighted and summed to produce a total PASI score ranging from 0 to 72, with higher scores indicating greater disease severity. |
| Secondary | Dermatology Life Quality Index (DLQI) | From enrollment to the end of treatment at 6 weeks and at 10 weeks (4 weeks after treatment cessation). | Validated Arabic translation will be used. DLQI is a validated questionnaire which grades QoL by assessing the following domains: (a) physical symptoms and feelings (questions 1 and 2), (b) daily activities (questions 3 and 4), (c) leisure (questions 5 and 6), (d) work/school (questions 7), (e) personal relationships (questions 8 and 9), and (f) treatment (question 10). Each question is scored as "very much" (score 3), "a lot" (score 2), "a little" (score 1), and "not at all" (score 0), keeping in mind the problems faced the previous week due to the disease. Final DLQI score is the sum of all scores (range 0-30). High scores indicate poor QoL. |
| Other | Pigmentary Alterations | At the end of treatment at 6 weeks and at 10 weeks (4 weeks after treatment cessation). | Detailed comparative assessments tracking the emergence of post-inflammatory hyperpigmentation or hypopigmentation within the target areas will be carried out across both cohorts. |
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.
Papers8
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/NCT07892339
GET https://conductscience.org/api/trials/v1/NCT07892339/registered