NCT07438509

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

• Status: Not Yet Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 270 (estimated)
• Sponsor: Jinnah Postgraduate Medical Centre · Other Government
• Sex: All
• Age: 12 Years – 50 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

Atopic dermatitis (AD), commonly referred to as atopic eczema, is a chronic, relapsing inflammatory skin disorder characterized by pruritus, erythema, and impaired skin barrier function. AD affects both children and adults and is associated with significant psychosocial burden, sleep disturbance, and reduced quality of life. Standard treatment options include topical corticosteroids and calcineurin inhibitors; however, prolonged use of these agents may be associated with adverse effects such as skin atrophy, irritation, and tachyphylaxis, highlighting the need for effective non-steroidal alternatives. Crisaborole 2% cream is a topical phosphodiesterase-4 (PDE4) inhibitor that reduces inflammation by inhibiting cyclic adenosine monophosphate degradation and decreasing pro-inflammatory cytokine production. International clinical trials have demonstrated its efficacy in mild to moderate AD, but limited data are available from South Asian populations. This study is a single-center, randomized, placebo-controlled trial conducted at the Department of Dermatology, Jinnah Postgraduate Medical Centre, Karachi. Participants aged 12 to 50 years with clinically diagnosed mild to moderate AD, defined by an ISGA score of 2 (mild) or 3 (moderate), will be enrolled after obtaining written informed consent. Participants will be randomized in a 1:1 ratio into two groups: Group A: Crisaborole 2% cream applied twice daily Group B: Placebo cream applied twice daily The treatment duration will be four weeks. Clinical assessments will be conducted at baseline, Day 14, and Day 28. The primary endpoint is treatment success at Day 28, defined as achieving an ISGA score of 0 or 1 with at least a two-grade improvement from baseline. Secondary evaluations will include safety assessment, monitoring of adverse events, and treatment adherence. Comparative analysis will determine whether Crisaborole 2% cream provides superior efficacy compared with placebo in managing mild to moderate AD.

Conditions

• Atopic Dermatitis (AD)
• Atopic Eczema

Interventions

Type	Name	Description
DRUG	Placebo Cream	Non-medicated topical cream identical in appearance and packaging to Crisaborole 2% cream, applied twice daily for four weeks.
DRUG	Crisaborole 2% Cream	Crisaborole 2% Cream

Timeline

• Start date: 2026-03-01
• Primary completion: 2026-09-01
• Completion: 2026-09-01
• First posted: 2026-02-27
• Last updated: 2026-03-06