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

Hayat Abad Medical Complex, Peshawar

Status and phase

Not yet enrolling

Phase 4

Conditions

Atopic Dermatitis

Treatments

Drug: Crisaborole 2% Topical Application Ointment [EUCRISA

Drug: tacrolimus 0.1%

Study type

Interventional

Funder types

Other

Identifiers

NCT07437534

Hayatabad Medical Complex

Details and patient eligibility

About

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

Enrollment

148 estimated patients

Sex

All

Ages

2+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

* 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).

Exclusion criteria

Exclusion Criteria:

* 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.