Fact CheckerSign in

NCT07438509Not yet recruitingPhase 4

Efficacy of Crisaborole 2% Cream Versus Placebo in Mild to Moderate Atopic Eczema

Evaluation of the Efficacy of Crisaborole 2% Cream Compared to Placebo in the Management of Mild to Moderate Atopic Eczema

Source: ClinicalTrials.gov · Last updated 6 Mar 2026

Brief summary (registry, in English)

This randomized controlled trial (RCT) aims to evaluate the efficacy and safety of Crisaborole 2% cream compared with placebo in patients with mild to moderate atopic dermatitis (AD), also known as atopic eczema. AD is a chronic inflammatory skin condition characterized by itching, redness, and recurrent flares that can significantly impair quality of life. Eligible participants aged 12 to 50 years with mild to moderate AD will be randomly assigned to receive either Crisaborole 2% cream or a placebo cream applied twice daily for four weeks. The primary outcome is treatment success at Day 28, defined using the Investigator's Static Global Assessment (ISGA) as a score of 0 (clear) or 1 (almost clear) with at least a two-grade improvement from baseline. Participants will be evaluated at baseline, Day 14, and Day 28. Safety, tolerability, and compliance will also be assessed. The results of this RCT may provide locally relevant evidence to guide the management of mild to moderate AD.

Status (registry)
Not yet recruiting
Phase (registry)
Phase 4
Study type
Interventional
Enrollment
270 (estimated)
First submitted
23 Feb 2026
Start date
1 Mar 2026
Primary completion date
1 Sept 2026
Lead sponsor
Jinnah Postgraduate Medical Centre
NCT number
NCT07438509

What you commit to

  • Study type: Interventional · Phase 4
  • Planned participants: 270
  • From 1 Mar 2026 to the primary completion date, 1 Sept 2026
  • No sites listed in no 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

  • Use of systemic corticosteroids, immunosuppressants, or antibiotics within the past two weeks

Other illness

  • Known hypersensitivity to crisaborole or any component of the formulation
  • Presence of other significant dermatological conditions that may interfere with evaluation (e.g., psoriasis, scabies)
  • Immunocompromised status (e.g., HIV infection, organ transplant recipient)

Other

  • Severe atopic dermatitis (ISGA score 4)
  • Pregnant or lactating women

Who the study is looking for

  • Age 12 to 50 years
  • Clinically diagnosed mild to moderate atopic dermatitis (ISGA score 2 or 3)
  • Willing and able to apply topical medication twice daily for four weeks
  • Able to provide written informed consent (parental consent for participants under 18 years)

Age in the registry: 12 years to 50 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

This page is information, not medical advice. Discuss any trial with your doctor.