A Phase 4 interventional study of Placebo Cream and Crisaborole 2% Cream in Atopic Dermatitis (AD) and Atopic Eczema, sponsored by Jinnah Postgraduate Medical Centre. Not yet recruiting. Open to participants aged 12 Years to 50 Years. Per ClinicalTrials.gov, last updated 2026-03-06.
Sponsored by Jinnah Postgraduate Medical Centre · Phase 4, Interventional, and Treatment
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.
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.
1,419 studies on the registry are indexed under Dermatitis, Atopic; 258 are open to participants now.
This study's planned enrollment of 270 is above the median of 83 across 1,125 interventional studies indexed under Dermatitis, Atopic.
Browse Dermatitis, Atopic studies →Jinnah Postgraduate Medical Centre is the lead sponsor of 38 studies on the registry; 14 are open to participants now.
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Exclusion Criteria:
Participants will apply Crisaborole 2% cream as a thin layer to affected areas twice daily for four weeks.
Drug: Crisaborole 2% Cream
Participants will apply a placebo cream identical in appearance and consistency to Crisaborole 2% cream, twice daily for four weeks.
Drug: Placebo Cream
Non-medicated topical cream identical in appearance and packaging to Crisaborole 2% cream, applied twice daily for four weeks.
Crisaborole 2% Cream
Proportion of Participants Achieving Treatment Success Based on Investigator's Static Global Assessment (ISGA)
Treatment success is defined as achieving an ISGA score of 0 (clear) or 1 (almost clear) with at least a 2-grade improvement from baseline.
Time frame: Day 28 (End of Treatment)
No study locations are listed for this record.
Plan to share: Yes — Individual participant data underlying the results reported in the manuscript, including baseline characteristics, ISGA scores, and outcome measures after de-identification.
Supporting information: Study protocol, Sap
This study is not yet recruiting, as verified in Feb 2026. You cannot join it, but the record below documents what was studied.
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Jinnah Postgraduate Medical Centre