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

February 26, 2026 updated by: Syeda Sana Zaman, Hayat Abad Medical Complex, Peshawar

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
148

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Locations

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

-

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: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Crisaborole Ointment 2%
crisaborole is a Phosphodiesterase 4 inhibitor approved for the topical treament of atopic dermatitis
Drug: Crisaborole 2% Topical Application Ointment [EUCRISA
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
Experimental: Tacrolimus 0.1%
Topical tacrolimus, used to treat atopic dermatitis, works by inhibiting T-cell activation and cytokine production.
Drug: tacrolimus 0.1%
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
≥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.
Time Frame: 8 weeks

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

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Hayat Abad Medical Complex, Peshawar

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 25, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 30, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 22, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 22, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 27, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 2, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 26, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Hayatabad Medical Complex

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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