Efficacy of Crisaborole 2% Cream Versus Placebo in Mild to Moderate Atopic Eczema (CRISA-AD)

March 4, 2026 updated by: Uroosa Shailkh, Jinnah Postgraduate Medical Centre

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

270

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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)

Exclusion Criteria:

  • Severe atopic dermatitis (ISGA score 4)
  • Use of systemic corticosteroids, immunosuppressants, or antibiotics within the past two weeks
  • Known hypersensitivity to crisaborole or any component of the formulation
  • Pregnant or lactating women
  • Presence of other significant dermatological conditions that may interfere with evaluation (e.g., psoriasis, scabies)
  • Immunocompromised status (e.g., HIV infection, organ transplant recipient)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Crisaborole 2% Cream
Participants will apply Crisaborole 2% cream as a thin layer to affected areas twice daily for four weeks.
Drug: Crisaborole 2% Cream
Crisaborole 2% Cream
Placebo Comparator: Placebo 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of Participants Achieving Treatment Success Based on Investigator's Static Global Assessment (ISGA)
Time Frame: Day 28 (End of Treatment)
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.
Day 28 (End of Treatment)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jinnah Postgraduate Medical Centre

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

  • 8. Fowler JF, Hebert AA, Del Rosso JQ. Patient-reported outcomes of crisaborole treatment in real-world settings. Clin Cosmet Investig Dermatol. 2021;14:1443-1452.
  • 7. Paller AS, Tom WL, Eichenfield LF. Efficacy of crisaborole ointment in pediatric patients with mild-to-moderate atopic dermatitis. JAMA Dermatol. 2020;156(5):556-563
  • 6. Eichenfield LF, Tom WL, Chamlin SL. Evaluation of the safety and efficacy of crisaborole ointment for the treatment of atopic dermatitis in children and adolescents: results from two phase 3 studies. J Am Acad Dermatol. 2021;85(4):892-900.
  • 5. Kaul S, Blauvelt A. Crisaborole: a nonsteroidal topical treatment for atopic dermatitis. Dermatol Ther. 2020;10(1):15-22.
  • 4. Blauvelt A, Simpson EL, Tyring SK, et al. Long-term management of atopic dermatitis: perspectives on current and emerging topical treatments. J Am Acad Dermatol. 2023;88(4):1001-1010.
  • 3. Kim JP, Chao LX, Simpson EL. Psychosocial burden of atopic dermatitis: A systematic review. Clin Dermatol. 2022;40(6):452-459
  • 2. Mahmood K, Akhtar F, Hussain M. Pattern and frequency of atopic dermatitis in Pakistani children: a multicenter cross-sectional study. Pak J Med Sci. 2021;37(3):891-895
  • 1. Odhiambo JA, Asher MI, Williams HC. Global variations in prevalence and severity of eczema symptoms in children. Int J Dermatol. 2020;59(5):582-589

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 1, 2026

Primary Completion (Estimated)

September 1, 2026

Study Completion (Estimated)

September 1, 2026

Study Registration Dates

First Submitted

February 23, 2026

First Submitted That Met QC Criteria

February 26, 2026

First Posted (Actual)

February 27, 2026

Study Record Updates

Last Update Posted (Actual)

March 6, 2026

Last Update Submitted That Met QC Criteria

March 4, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • JPMC-CRISA-2026-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Individual participant data underlying the results reported in the manuscript, including baseline characteristics, ISGA scores, and outcome measures after de-identification.

IPD Sharing Time Frame

Beginning 6 months after publication and ending 5 years after publication.

IPD Sharing Access Criteria

Researchers who provide a methodologically sound proposal.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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