Dermatitis, AtopicPhase 4NCT07367932
Comparative Study of Crisaborole vs. Tacrolimus in Atopic Dermatitis
A Phase 4 study testing Application of crisaborole twice daily and Tacrolimus ointment in atopic dermatitis in people with Dermatitis, Atopic and Eczema, run by Cairo University.
Trial summary
This study will compare the efficacy and safety of crisaborole ointment with tacrolimus ointment, in the treatment of patients with mild-to-moderate atopic dermatitis. Read more about this study
- Who is it for?
- Ages 5 to 25 years
- Conditions the study is for
- Dermatitis, Atopic, Eczema
- What is being tested?
- Application of crisaborole twice daily and Tacrolimus ointment in atopic dermatitis
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Feb 2026to Jul 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 5 to 25 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Patients with diagnosis of AD, according to Hanifin and Rajka criteria.
- Patients of both genders
- Age 5-25 years
- Baseline Investigator's Static Global Assessment (ISGA) score of mild (2) or moderate (3).
Who cannot join
- Clinically infected eczema.
- Baseline Investigator's Static Global Assessment (ISGA) score of severe (4).
- Associated comorbidities that exacerbate pruritus.
- Patients receiving topical treatment for AD and/or pruritus within the past 14 days and/or systemic treatment within the past month.
- Pregnancy and lactation if in the childbearing period
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Crisaborole 2% Versus Tacrolimus 0.03% Ointments for the Treatment of Mild to Moderate Atopic Dermatitis: A Comparative Study
This study will compare the efficacy and safety of crisaborole ointment with tacrolimus ointment, in the treatment of patients with mild-to-moderate atopic dermatitis.
- Conditions
- Dermatitis, Atopic, Eczema
- Being tested
- Application of crisaborole twice daily, Tacrolimus ointment in atopic dermatitis
- Keywords
- Tacrolimus, Crisaborole, Atopic dermatitis
- Medical subject headings
- Dermatitis, Atopic, Eczema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Application of crisaborole twice dailyDrug
compare the efficacy and safety of crisaborole ointment on mild to moderate atopic dermatitis for 1 month and followup in 2 months
Tacrolimus ointment in atopic dermatitisDrug
compare the efficacy and safety of tacrolimus ointment, in the treatment of patients with mild-to-moderate atopic dermatitis
| Study group | Role | What they receive |
|---|---|---|
| Crisaborole ointment | Active comparator | Not described Receives: Drug: Application of crisaborole twice daily |
| Tacrolimus ointment | Active comparator | Not described Receives: Drug: Tacrolimus ointment in atopic dermatitis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement of Investigator's Static Global Assessment score
- Assessment of the Investigator's Static Global Assessment scores before and after treatment with crisaborole 2% ointment.
- Assessment of the Investigator's Static Global Assessment before and after treatment with tacrolimus 0.03% ointment.
- Comparison of the percentage of improvement in the Investigator's Static Global Assessment between the two treatment groups.
Measured: 3 months
Improvement of Eczema Area and Severity Index
- Assessment of Eczema Area and Severity Index scores before and after the use of crisaborole 2% ointment.
- Assessment of Eczema Area and Severity Index scores before and after the use of tacrolimus 0.03% ointment.
- Comparison of the percentage of improvement in the Eczema Area and Severity Index scores between the two treatment groups
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2026
- Study startFeb 2026 (estimated)
- Primary completionApr 2026 (estimated)
- Study completionJul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dermatitis, AtopicStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amira Elbendary, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07367932
- Sponsor's protocol ID
- MS-61-2025
- Status last verified
- Jan 2026
- First submitted
- 28 Dec 2025
- Last updated
- 26 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Crisaborole 2% Versus Tacrolimus 0.03% Ointments for the Treatment of Mild to Moderate Atopic Dermatitis: A Comparative Study
- ClinicalTrials.gov ID
- NCT07367932
- Acronym / sponsor ID
- MS-61-2025
- Conditions
- Dermatitis, Atopic, Eczema
- Keywords
- Tacrolimus, Crisaborole, Atopic dermatitis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Feb 2026 (estimated)
- Primary completion
- Apr 2026 (estimated)
- Study completion
- Jul 2026 (estimated)
- First posted
- 26 Jan 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.
This study will compare the efficacy and safety of crisaborole ointment with tacrolimus ointment, in the treatment of patients with mild-to-moderate atopic dermatitis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Crisaborole ointment | Active comparator | Drug: Application of crisaborole twice daily |
| Tacrolimus ointment | Active comparator | Drug: Tacrolimus ointment in atopic dermatitis |
Who may qualify
- Ages
- 5 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Patients with diagnosis of AD, according to Hanifin and Rajka criteria.
- Patients of both genders
- Age 5-25 years
- Baseline Investigator's Static Global Assessment (ISGA) score of mild (2) or moderate (3).
Key exclusion criteria (5 listed)
- Clinically infected eczema.
- Baseline Investigator's Static Global Assessment (ISGA) score of severe (4).
- Associated comorbidities that exacerbate pruritus.
- Patients receiving topical treatment for AD and/or pruritus within the past 14 days and/or systemic treatment within the past month.
- Pregnancy and lactation if in the childbearing period
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 |
|---|---|---|
| Application of crisaborole twice dailycompare the efficacy and safety of crisaborole ointment on mild to moderate atopic dermatitis for 1 month and followup in 2 months | Drug | Crisaborole ointment |
| Tacrolimus ointment in atopic dermatitiscompare the efficacy and safety of tacrolimus ointment, in the treatment of patients with mild-to-moderate atopic dermatitis | Drug | Tacrolimus ointment |
Primary outcome
Improvement of Investigator's Static Global Assessment score
Time frame: 3 months
1. Assessment of the Investigator's Static Global Assessment scores before and after treatment with crisaborole 2% ointment. 2. Assessment of the Investigator's Static Global Assessment before and after treatment with tacrolimus 0.03% ointment. 3. Comparison of the percentage of improvement in the Investigator's Static Global Assessment between the two treatment groups.
Improvement of Eczema Area and Severity Index
Time frame: 3 months
1. Assessment of Eczema Area and Severity Index scores before and after the use of crisaborole 2% ointment. 2. Assessment of Eczema Area and Severity Index scores before and after the use of tacrolimus 0.03% ointment. 3. Comparison of the percentage of improvement in the Eczema Area and Severity Index scores between the two treatment groups
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 26 Jan 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.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Application of crisaborole twice daily and Tacrolimus ointment in atopic dermatitis in people with Dermatitis, Atopic and Eczema, run by Cairo University.
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 4 inclusion and 5 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 26 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
Contact Aya Raafat Khalil, MBBcH (+201120807903, ayah.rafaat.97@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement of Investigator's Static Global Assessment score (time frame: 3 months). The study lists 2 primary outcomes in all. 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 26 Jan 2026.