A Phase 3 interventional study of Crisaborole 2% and Tacrolimus 0.1% in Atopic Dermatitis and Atopic Dermatitis (AD), sponsored by Shalamar Institute of Health Sciences. Not yet recruiting at 1 site in Pakistan. Open to participants aged 2 Years to 18 Years. Per ClinicalTrials.gov, last updated 2025-09-09.
Sponsored by Shalamar Institute of Health Sciences · Phase 3, Interventional, and Treatment
This randomized, open-label, parallel-group study will compare the efficacy and safety of Crisaborole 2% ointment and Tacrolimus 0.1% ointment in children with mild to moderate atopic dermatitis. A total of 66 participants will be randomized (1:1) to receive either Crisaborole or Tacrolimus, applied twice daily to affected areas for 28 days. Primary endpoint is proportion of participants achieving Investigator's Static Global Assessment (ISGA) success (clear/almost clear with ≥2-point improvement from baseline) at Day 28. Safety assessments include adverse events and local application site reactions.
1,591 studies on the registry are indexed under Dermatitis, Atopic; 286 are open to participants now.
This study's planned enrollment of 66 is below the median of 82 across 1,246 interventional studies indexed under Dermatitis, Atopic.
Browse Dermatitis, Atopic studies →Shalamar Institute of Health Sciences is the lead sponsor of 17 studies on the registry; 13 are open to participants now.
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Exclusion Criteria:
Active viral, bacterial, or fungal skin infection at the treatment site
Recent use of topical , calcineurin inhibitors, PDE4 inhibitors, or medication within past 2 weeks
Known to study medications or components
Chronic inflammatory conditions (e.g., psoriasis and seborrheic dermatitis) that may interfere with evaluation
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
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An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
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Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Twice daily application to affected areas for 28 days
Drug: Crisaborole 2%
Twice daily application to affected areas for 28 days
Drug: Tacrolimus 0.1%
Apply thin layer to affected skin daily for 28 days.
Apply thin layer to affected skin daily for 28 days.
Proportion of Participants with ISGA sucess ( clear / almost clear from baseline) at day 28.
Time frame: 28 days
Change in ISGA from baseline to day 28.
ISGA uses a 5-point scale (0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe); negative change indicates improvement.
Time frame: Baseline, Day 14, Day 28
Plan to share: No
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This study is not yet recruiting, as verified in Aug 2025. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Crisaborole · Tacrolimus
Shalamar Institute of Health Sciences