Comparative Evaluation of the Safety and Effectiveness of Crisaborole Ointment (2%) Versus Tacrolimus Ointment (0.1%) for the Topical Treatment of Atopic Dermatitis

NCT07437534 | Not Yet Recruiting Phase 4 DMC

• 1 other identifier: Hayatabad Medical Complex
• Study Type: interventional
• Target: 148
• Locations: 1 country
• Sites: 1

Brief Summary

Atopic dermatitis (AD), commonly known as eczema, is a chronic skin condition that causes itchy, red, and scaly patches on the skin. It often starts in childhood but can continue into adulthood, affecting a person's quality of life. People with AD may also suffer from asthma or allergies, as these conditions are linked. The exact cause is unclear, but it involves a mix of genetics, immune system problems, and environmental factors\*\* like pollution or dry weather. In developed countries, about 20% of children and 1-10% of adults have AD, and cases have been increasing over the years. In Asia, including Pakistan, studies suggest 3.5-20% of children and up to 10% of adults may have it. However, in Pakistan, only 10% of children and 2-5% of adults are officially diagnosed, likely because many cases go \*untreated or misdiagnosed. People often try home remedies or self-medication before seeing a doctor, which delays proper care. Current Treatments and Their Problems The standard treatment includes: Moisturizers - Help repair the skin barrier. Topical Steroids (creams/ointments) - Reduce inflammation but can thin the skin if used too long. Steroid-Free Alternatives - Used to avoid steroid side effects. Two key steroid-free options are: Tacrolimus (0.1% ointment) - Works well for moderate-to-severe eczema but can cause burning, itching, and has a \*\*cancer risk warning (though rare). Crisaborole (2% ointment) - A newer treatment for mild-to-moderate eczema, with fewer side effects but less research on its long-term use. Why This Study is Needed Most research on these treatments comes from Western countries, and Pakistani patients may respond differently due to: Climate\* (hot, humid weather affects skin). Pollution and dust, which worsen eczema. Limited access to specialists, leading to late diagnosis. There are no direct comparisons\* between tacrolimus and crisaborole in Pakistan, making it hard for doctors to choose the best option. What This Study Will Do This research will \*compare tacrolimus 0.1% and crisaborole 2% in Pakistani patients with eczema to see: Which works better? (Measured by clear/almost clear skin after 6 weeks). Which is safer? (Fewer side effects like burning or infections). Which improves quality of life? (Less itching, better sleep). How the Study Will Work Patients (adults and children over 2 years) with mild-to-moderate eczema will be divided into two groups: One group uses tacrolimus ointment twice daily. The other uses crisaborole ointment twice daily. Doctors will check their skin at start, 2 ,4 and 8 weeks\* to see improvements. Side effects and patient feedback will be recorded. Expected Results Tacrolimus might work better for severe cases but could cause more irritation. Crisaborole may be gentler, especially for children and sensitive skin. The findings will help Pakistani doctors make better treatment choices and improve eczema care in the country. Why This Matters Eczema is a lifelong condition, and using the wrong treatment can lead to worse flare-ups, infections, or side effects. Since steroids are overused in Pakistan, safer alternatives like tacrolimus and crisaborole need proper testing in local patients. This study will provide evidence-based guidelines for eczema treatment in Pakistan, helping patients get effective and safe care

Conditions

Atopic Dermatitis

Outcome Measures

Primary Outcomes (1)

• ≥50% Change in SCORAD score (SCORing Atopic Dermatitis)from baseline at 8 weeks with minimum score of 0 and maximum score of 103 ; higher score indicating more severe disease and lower score indicating better disease control.

  Treatment will be continued for 8 weeks. SCORAD scores will be recorded at baseline and 8 weeks. Effectiveness will be defined as ≥50% change in SCORAD score from baseline at 8 weeks. The SCORAD score combines objective signs and subjective symptoms into a single score (0-103). Objective Signs (A) - Extent (0-100) and Intensity(0-18) Subjective Symptoms (C) - Itch and Sleeplessness Each is scored by the patient (or caregiver) on a visual analog scale (VAS) from 0 to 10: SCORAD} = \\frac{A}{5} + 7 \\times \\frac{B}{2} + C Where: A = extent (0-100) B = intensity (0-18) C = subjective symptoms (0-20) Interpretation Mild: \< 25 Moderate: 25-50 Severe: \> 50 .Higher score means more severe disease whereas low score indicates better disease control. Minimum value:0 Maximum value:103

  8 weeks

Study Arms (2)

Crisaborole Ointment 2%

EXPERIMENTAL

crisaborole is a Phosphodiesterase 4 inhibitor approved for the topical treament of atopic dermatitis

Drug: Crisaborole 2% Topical Application Ointment [EUCRISA

Tacrolimus 0.1%

EXPERIMENTAL

Topical tacrolimus, used to treat atopic dermatitis, works by inhibiting T-cell activation and cytokine production.

Drug: tacrolimus 0.1%

Interventions

Crisaborole 2% Topical Application Ointment [EUCRISA DRUG

Tacrolimus works well for moderate to severe eczema but can cause burning, itching and cancer risk. Crisaborole is newer treatment for mild to moderate eczema with fewer side effects

Crisaborole Ointment 2%

tacrolimus 0.1% DRUG

Tacrolimus works well for moderate to severe eczema but can cause burning, itching and cancer risk. Crisaborole is newer treatment for mild to moderate eczema with fewer side effects

Tacrolimus 0.1%

Eligibility Criteria

• Age: 2 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• \* Patients aged ≥2 years of either gender.
• Diagnosed with mild to moderate atopic dermatitis based on Hanifin and Rajka criteria.
• SCORAD score between 15 and 40. Willing to participate and provide informed consent (from guardian for minors).

You may not qualify if:

• \* Severe atopic dermatitis (SCORAD \> 40).
• History of hypersensitivity to tacrolimus or crisaborole. Use of systemic immunosuppressive therapy within the past 4 weeks. Presence of secondary bacterial or viral skin infection. Pregnant or lactating females.

Sponsors & Collaborators

• Hayat Abad Medical Complex, Peshawar: lead

Study Sites (1)

Hayatabad Medical Complex

Peshawar, KPK, Pakistan

Location

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

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Trainee Medical Officer

Study Record Dates

• First Submitted: February 22, 2026
• First Posted: February 27, 2026
• Study Start: March 1, 2026
• Primary Completion: April 25, 2026
• Study Completion (Estimated): August 30, 2026
• Last Updated: March 2, 2026

Record last verified: 2026-02

Locations

PA (1)