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Atopic DermatitiseczemaNCT07519174

A Randomized Controlled Trial Comparing the Effectiveness and Safety of Topical Tacrolimus 0.03% Versus Crisaborole 2% in Patients With Mild to Moderate Atopic Dermatitis Over 8 Weeks

A study testing Tacrolimus and Crisaborole 2% Top Oint in people with Atopic Dermatitis, run by Foundation University Islamabad at 1 site in Pakistan.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

This randomized controlled trial compares the effectiveness and safety of topical tacrolimus 0.03% and crisaborole 2% in patients with mild to moderate atopic dermatitis over 8 weeks. Read more about this study

Who is it for?
Ages 2 to 20 years
Conditions the study is for
Atopic Dermatitis
What is being tested?
Tacrolimus and Crisaborole 2% Top Oint
Could I receive a placebo?
No, everyone receives an active treatment
How many people
72 participants
Where
1 sitePakistan
Study dates
1 Jun 2026to 1 Jan 2027
Phase
Interventional
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 to 20 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • Age 2-20 years Clinically diagnosed mild to moderate AD EASI score ≤21 Informed consent

Who cannot join

  • Severe AD (EASI \>21) Use of topical/systemic corticosteroids within 2 weeks Secondary infection Known drug hypersensitivity Immunocompromised state

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Sana Khan, FCPS, Fellowship in Derma contact

+923391123231

drsanaderm@gmail.com

Dr. Asma Javed, FCPS Derma contact

+923009719514

ajkiani@hotmail.com

Pakistan1 site
  • Fauji Foundation Hospital, Rawalpindi

    Rawalpindi, Punjab Province, 44000

    Dr. Sana Khan, FCPS, +923391123231, drsanaderm@gmail.com

Other trials in Pakistan

About this study

This randomized controlled trial compares the effectiveness and safety of topical tacrolimus 0.03% and crisaborole 2% in patients with mild to moderate atopic dermatitis over 8 weeks. Atopic dermatitis is a chronic inflammatory skin condition affecting quality of life, and steroid-sparing treatments are increasingly preferred due to adverse effects of long-term corticosteroid use. Tacrolimus, a calcineurin inhibitor, and crisaborole, a PDE-4 inhibitor, are both effective alternatives, though tacrolimus may offer greater efficacy while crisaborole has better tolerability. The study will include 70 patients aged 2-20 years, randomized into two groups receiving either treatment. Outcomes will be assessed using EASI score reduction and adverse effects. Data will be analyzed statistically to determine significance. The study aims to generate local evidence to guide treatment decisions and improve management strategies for atopic dermatitis in the Pakistani population.

Read the detailed description

This randomised controlled trial is designed to evaluate and compare the effectiveness and safety of two commonly used steroid-sparing topical therapies-tacrolimus 0.03% and crisaborole 2%-in patients with mild to moderate atopic dermatitis over an 8-week period. Atopic dermatitis is a chronic inflammatory condition marked by itching, dryness, and recurrent eczematous lesions, often resulting from a combination of impaired skin barrier function and immune dysregulation. While topical corticosteroids are widely used, their long-term adverse effects have led clinicians to increasingly rely on alternative agents such as calcineurin inhibitors and PDE-4 inhibitors. In this study, patients aged 2 to 20 years meeting the inclusion criteria will be enrolled and allocated into two treatment groups through randomization. One group will receive tacrolimus 0.03% ointment, while the other will receive crisaborole 2%, both applied twice daily. Baseline data including demographic details, disease duration, EASI score, and pruritus severity will be recorded, followed by reassessment at weeks 4 and 8. The primary measure of effectiveness will be the reduction in EASI score, while safety will be evaluated based on the frequency and type of adverse effects such as burning or irritation. Statistical analysis will be conducted using appropriate tests to compare outcomes between groups. The study aims to generate locally relevant evidence to guide clinical decision-making, with the expectation that tacrolimus may demonstrate superior efficacy, while both treatments maintain acceptable tolerability profiles.

Being tested
Tacrolimus, Crisaborole 2% Top Oint
Keywords
Dermatitis, atopic, tacrolimus, Calcineurin inhibitors, crisaborole
Medical subject headings
Dermatitis, Atopic, Dermatitis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TacrolimusDrug

    Also called calcineurin inhibitor

    Tacrolimus 0.03% ointment applied twice daily to affected areas for 8 weeks. Tacrolimus is a topical calcineurin inhibitor that reduces T-cell activation and inflammatory cytokine release, improving eczema severity. Outcomes (EASI score, pruritus VAS, adverse effects) assessed at baseline, Week 4, and Week 8.

  • Crisaborole 2% Top OintDrug

    Also called phosphodiesterase 4 inibitor

    Crisaborole 2% ointment applied twice daily to affected areas for 8 weeks. Crisaborole is a topical phosphodiesterase-4 inhibitor that modulates inflammatory pathways and restores skin homeostasis. Outcomes (EASI score, pruritus VAS, adverse effects) assessed at baseline, Week 4, and Week 8.

Study groups in NCT07519174
Study groupRoleWhat they receive
Tacrolimus 0.03% OintmentExperimentalParticipants will apply tacrolimus 0.03% ointment twice daily to affected areas for 8 weeks. Tacrolimus is a topical calcineurin inhibitor that reduces T-cell activation and inflammatory cytokine release, improving eczema severity. Outcomes-including EASI score, pruritus VAS, and adverse effects-will be assessed at baseline, Week 4, and Week 8. Describe the intervention(s) to be administered. For drugs use generic name and include dosage form, dosage, frequency and duration.
Receives: Drug: Tacrolimus
Crisaborole 2% OintmentActive comparatorParticipants will apply crisaborole 2% ointment twice daily to affected areas for 8 weeks. Crisaborole is a topical phosphodiesterase-4 inhibitor that modulates inflammatory pathways and restores skin homeostasis. Outcomes-including EASI score, pruritus VAS, and adverse effects-will be assessed at baseline, Week 4, and Week 8.
Receives: Drug: Crisaborole 2% Top Oint

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. mean reduction In EASI score.

    Change in EASI score from baseline to Week 8. Greater reduction indicates better disease control.

    Measured: baseline to 8 weeks

Secondary outcomes (1)
  1. Safety / Tolerability

    Frequency of treatment-related adverse effects such as burning, stinging, erythema, or local irritation.

    Measured: throughout 8 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Apr 2026
  2. Study start1 Jun 2026 (estimated)
  3. Primary completion1 Nov 2026 (estimated)
  4. Study completion1 Jan 2027 (estimated)

Resources

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 N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
This is a parallel-group randomized controlled trial. Participants with mild-to-moderate atopic dermatitis will be randomly assigned to either tacrolimus 0.03% ointment or crisaborole 2% ointment, applied twice daily for 8 weeks. Each participant will remain in their assigned group throughout the study, and outcomes-including EASI score, pruritus, and adverse effects-will be assessed at baseline, Week 4, and Week 8 to compare the effectiveness and safety of the two treatments.
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
72 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07519174
Sponsor's protocol ID
FUMCRCT6
Acronym
eczema
Status last verified
Apr 2026
First submitted
2 Apr 2026
Last updated
9 Apr 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Kulthanan K, Tuchinda P, Nitiyarom R, Chunharas A, Chantaphakul H, Aunhachoke K, Chularojanamontri L, Rajatanavin N, Jirapongsananuruk O, Vichyanond P, Chatchatee P, Sangsupawanich P, Wananukul S, Singalavanija S, Trakanwittayarak S, Rerkpattanapipat T, Thongngarm T, Wisuthsarewong W, Limpongsanurak W, Kamchaisatian W, Noppakun N. Clinical practice guidelines for the diagnosis and management of atopic dermatitis. Asian Pac J Allergy Immunol. 2021 Sep;39(3):145-155. doi: 10.12932/AP-010221-1050.

    PubMed 34246205
  • AAAAI/ACAAI JTF Atopic Dermatitis Guideline Panel; Chu DK, Schneider L, Asiniwasis RN, Boguniewicz M, De Benedetto A, Ellison K, Frazier WT, Greenhawt M, Huynh J, Kim E, LeBovidge J, Lind ML, Lio P, Martin SA, O'Brien M, Ong PY, Silverberg JI, Spergel JM, Wang J, Wheeler KE, Guyatt GH; Patient Groups: Global Parents for Eczema Research; Capozza K; National Eczema Association; Begolka WS; Evidence in Allergy Group; Chu AWL, Zhao IX, Chen L, Oykhman P, Bakaa L; AAAAI/ACAAI Joint Task Force on Practice Parameters; Golden D, Shaker M, Bernstein JA, Greenhawt M, Horner CC, Lieberman J, Stukus D, Rank MA, Wang J, Ellis A, Abrams E, Ledford D, Chu DK. Atopic dermatitis (eczema) guidelines: 2023 American Academy of Allergy, Asthma and Immunology/American College of Allergy, Asthma and Immunology Joint Task Force on Practice Parameters GRADE- and Institute of Medicine-based recommendations. Ann Allergy Asthma Immunol. 2024 Mar;132(3):274-312. doi: 10.1016/j.anai.2023.11.009. Epub 2023 Dec 18.

    PubMed 38108679
  • Chu DK, Chu AWL, Rayner DG, Guyatt GH, Yepes-Nunez JJ, Gomez-Escobar L, Perez-Herrera LC, Diaz Martinez JP, Brignardello-Petersen R, Sadeghirad B, Wong MM, Ceccacci R, Zhao IX, Basmaji J, MacDonald M, Chu X, Islam N, Gao Y, Izcovich A, Asiniwasis RN, Boguniewicz M, De Benedetto A, Capozza K, Chen L, Ellison K, Frazier WT, Greenhawt M, Huynh J, LeBovidge J, Lio PA, Martin SA, O'Brien M, Ong PY, Silverberg JI, Spergel JM, Smith Begolka W, Wang J, Wheeler KE, Gardner DD, Schneider L. Topical treatments for atopic dermatitis (eczema): Systematic review and network meta-analysis of randomized trials. J Allergy Clin Immunol. 2023 Dec;152(6):1493-1519. doi: 10.1016/j.jaci.2023.08.030. Epub 2023 Sep 9.

    PubMed 37678572
  • Butala S, Paller AS. Optimizing topical management of atopic dermatitis. Ann Allergy Asthma Immunol. 2022 May;128(5):488-504. doi: 10.1016/j.anai.2022.03.004. Epub 2022 Mar 12.

    PubMed 35288275
  • Lax SJ, Van Vogt E, Candy B, Steele L, Reynolds C, Stuart B, Parker R, Axon E, Roberts A, Doyle M, Chu DK, Futamura M, Santer M, Williams HC, Cro S, Drucker AM, Boyle RJ. Topical anti-inflammatory treatments for eczema: network meta-analysis. Cochrane Database Syst Rev. 2024 Aug 6;8(8):CD015064. doi: 10.1002/14651858.CD015064.pub2.

    PubMed 39105474
  • Kim M, Del Duca E, Cheng J, Carroll B, Facheris P, Estrada Y, Cha A, Werth J, Bissonnette R, Nocka K, Zang C, Pavel AB, Guttman-Yassky E. Crisaborole reverses dysregulation of the mild to moderate atopic dermatitis proteome toward nonlesional and normal skin. J Am Acad Dermatol. 2023 Aug;89(2):283-292. doi: 10.1016/j.jaad.2023.02.064. Epub 2023 Apr 11.

    PubMed 37054814
  • Chakraborty D, De A, Khan A, Dhar S, Raychaudhuri SP. Comparative evaluation of the efficacy and safety of crisaborole ointment (2%) versus tacrolimus ointment (0.1%) for the topical treatment of atopic dermatitis: an open-labeled single-blinded randomized controlled trial. Int J Dermatol. 2025 Feb;64(2):402-404. doi: 10.1111/ijd.17572. Epub 2024 Nov 20. No abstract available.

    PubMed 39564717

Questions about this trial

What is this clinical trial studying?

A study testing Tacrolimus and Crisaborole 2% Top Oint in people with Atopic Dermatitis, run by Foundation University Islamabad 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 1 inclusion and 1 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 9 Apr 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.

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 Sana Khan, FCPS, Fellowship in Derma (+923391123231, drsanaderm@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

mean reduction In EASI score. (time frame: baseline to 8 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07519174, which also lists 7 linked publications.

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 9 Apr 2026.

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