NCT07162896Not yet recruitingPhase 3
Crisaborole 2% Versus Tacrolimus 0.1% in Children With Mild to Moderate Atopic Dermatitis
Efficacy and Safety of Crisaborole 2% Versus Tacrolimus 0.1% in Children With Mild to Moderate Atopic Dermatitis
Source: ClinicalTrials.gov · Last updated 9 Sept 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
This randomized, open-label, parallel-group study will compare the efficacy and safety of Crisaborole 2% ointment and Tacrolimus 0.1% ointment in children with mild to moderate atopic dermatitis. A total of 66 participants will be randomized (1:1) to receive either Crisaborole or Tacrolimus, applied twice daily to affected areas for 28 days. Primary endpoint is proportion of participants achieving Investigator's Static Global Assessment (ISGA) success (clear/almost clear with ≥2-point improvement from baseline) at Day 28. Safety assessments include adverse events and local application site reactions.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 66 (estimated)
- First submitted
- 31 Aug 2025
- Start date
- Jun 2026
- Primary completion date
- Jan 2027
- Lead sponsor
- Shalamar Institute of Health Sciences
- Diseases
- Atopic dermatitis (eczema)
- NCT number
- NCT07162896
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 66
- From Jun 2026 to the primary completion date, Jan 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Recent use of topical corticosteroids, calcineurin inhibitors, PDE4 inhibitors, or immunosuppressive medication within past 2 weeks
Other illness
- Active viral, bacterial, or fungal skin infection at the treatment site
- Known hypersensitivity to study medications or components
- Chronic inflammatory conditions (e.g., psoriasis and seborrheic dermatitis) that may interfere with evaluation
Who the study is looking for
- Age 2-18 years Both genders Clinically diagnosed mild to moderate atopic dermatitis Body surface area (BSA) \<30%
Age in the registry: 2 years to 18 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Shalamar Hospital, lahore Coordinator of this site? Confirm its status | Lahore | Pakistan | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.