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

NCT07438509 | Not Yet Recruiting Phase 4

• 1 other identifier: JPMC-CRISA-2026-01
• Study Type: interventional
• Target: 270
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Atopic Dermatitis (AD); Atopic Eczema

Keywords

Mild to Moderate Atopic Dermatitis; Crisaborole; Phosphodiesterase-4 Inhibitor; Topical Therapy

Outcome Measures

Primary Outcomes (1)

• 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.

  Day 28 (End of Treatment)

Study Arms (2)

Crisaborole 2% Cream

EXPERIMENTAL

Participants will apply Crisaborole 2% cream as a thin layer to affected areas twice daily for four weeks.

Drug: Crisaborole 2% Cream

Placebo Cream

PLACEBO COMPARATOR

Participants will apply a placebo cream identical in appearance and consistency to Crisaborole 2% cream, twice daily for four weeks.

Drug: Placebo Cream

Interventions

Placebo Cream DRUG

Non-medicated topical cream identical in appearance and packaging to Crisaborole 2% cream, applied twice daily for four weeks.

Placebo Cream

Crisaborole 2% Cream DRUG

Crisaborole 2% Cream

Crisaborole 2% Cream

Eligibility Criteria

• Age: 12 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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)

Sponsors & Collaborators

• Jinnah Postgraduate Medical Centre: lead

Related Publications (8)

• 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.

  RESULT

• 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

  RESULT

• 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.

  RESULT

• 5. Kaul S, Blauvelt A. Crisaborole: a nonsteroidal topical treatment for atopic dermatitis. Dermatol Ther. 2020;10(1):15-22.

  RESULT

• 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.

  RESULT

• 3. Kim JP, Chao LX, Simpson EL. Psychosocial burden of atopic dermatitis: A systematic review. Clin Dermatol. 2022;40(6):452-459

  RESULT

• 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

  RESULT

• 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

  RESULT

MeSH Terms

Conditions

Dermatitis, Atopic

Interventions

crisaborole

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Central Study Contacts

Uroosa Shaikh, FCPS

CONTACT

03366601694; uroosashaikh654@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Participants, care providers, investigators, and outcome assessors will be blinded to treatment allocation. Study medications will be identical in appearance, packaging, and labeling to maintain blinding.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PGR

Model Details: Participants will be randomized in a 1:1 ratio to receive either Crisaborole 2% cream or placebo cream applied twice daily for four weeks. Each participant will remain in the assigned group throughout the study period.

Study Record Dates

• First Submitted: February 23, 2026
• First Posted: February 27, 2026
• Study Start: March 1, 2026
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: March 6, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Beginning 6 months after publication and ending 5 years after publication.
• Access Criteria: Researchers who provide a methodologically sound proposal.