Atopic DermatitisPhase 4NCT07437534
Comparative Evaluation of the Safety and Effectiveness of Crisaborole Ointment (2%) Versus Tacrolimus Ointment (0.1%) for the Topical Treatment of Atopic Dermatitis
A Phase 4 study testing Crisaborole 2% Topical Application Ointment [EUCRISA and tacrolimus 0.1% in people with Atopic Dermatitis, run by Hayat Abad Medical Complex, Peshawar at 1 site in Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Ages 2 years and older
- Conditions the study is for
- Atopic Dermatitis
- What is being tested?
- Crisaborole 2% Topical Application Ointment [EUCRISA and tacrolimus 0.1%
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 148 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Mar 2026to 30 Aug 2026
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- -
- 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.
- -
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Pakistan1 site
Hayatabad Medical Complex
Peshawar, KPK
Dr Ayesha Ahsan, MBBS,FCPS 1, 03101188666, ayeshaareebaihsan@gmail.com
About this study
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.
Read more
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
- Being tested
- Crisaborole 2% Topical Application Ointment [EUCRISA, tacrolimus 0.1%
- Medical subject headings
- Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Crisaborole 2% Topical Application Ointment [EUCRISADrug
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%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
| Study group | Role | What they receive |
|---|---|---|
| Crisaborole Ointment 2% | Experimental | crisaborole is a Phosphodiesterase 4 inhibitor approved for the topical treament of atopic dermatitis Receives: 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. Receives: Drug: tacrolimus 0.1% |
What is being measured
The primary outcome is the main question the study is designed to answer.
≥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
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2026
- Study start1 Mar 2026 (estimated)
- Primary completion25 Apr 2026 (estimated)
- Study completion30 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atopic DermatitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 148 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hayat Abad Medical Complex, Peshawar
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Syeda Sana Zaman, Hayat Abad Medical Complex, Peshawar
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07437534
- Sponsor's protocol ID
- Hayatabad Medical Complex
- Status last verified
- Feb 2026
- First submitted
- 22 Feb 2026
- Last updated
- 2 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Evaluation of the Safety and Effectiveness of Crisaborole Ointment (2%) Versus Tacrolimus Ointment (0.1%) for the Topical Treatment of Atopic Dermatitis
- ClinicalTrials.gov ID
- NCT07437534
- Acronym / sponsor ID
- Hayatabad Medical Complex
- Conditions
- Atopic Dermatitis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 148 participants (estimated)
- Lead sponsor
- Hayat Abad Medical Complex, PeshawarOther government
- Study start
- 1 Mar 2026 (estimated)
- Primary completion
- 25 Apr 2026 (estimated)
- Study completion
- 30 Aug 2026 (estimated)
- First posted
- 27 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Crisaborole Ointment 2% | Experimental | Drug: Crisaborole 2% Topical Application Ointment [EUCRISAcrisaborole is a Phosphodiesterase 4 inhibitor approved for the topical treament of atopic dermatitis |
| Tacrolimus 0.1% | Experimental | Drug: tacrolimus 0.1%Topical tacrolimus, used to treat atopic dermatitis, works by inhibiting T-cell activation and cytokine production. |
Who may qualify
- Ages
- 2 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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).
Key exclusion criteria (4 listed)
- -
- 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.
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Crisaborole 2% Topical Application Ointment [EUCRISATacrolimus 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 | Drug | Crisaborole Ointment 2% |
| 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 | Drug | Tacrolimus 0.1% |
Primary outcome
≥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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Crisaborole 2% Topical Application Ointment [EUCRISA and tacrolimus 0.1% in people with Atopic Dermatitis, run by Hayat Abad Medical Complex, Peshawar at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 2 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
≥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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Mar 2026.