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NOT YET RECRUITING
NCT07438509
PHASE4

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

Sponsor: Jinnah Postgraduate Medical Centre

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

12 Years - 50 Years

Study Type

INTERVENTIONAL

Enrollment

270

Start Date

2026-03-01

Completion Date

2026-09-01

Last Updated

2026-03-06

Healthy Volunteers

No

Interventions

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