Ignite Creation Date:
2026-03-26 @ 3:19 PM
Ignite Modification Date:
2026-03-31 @ 5:00 AM
Study NCT ID:
NCT07437534
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-03-02
First Post:
2026-02-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparative Evaluation of the Safety and Effectiveness of Crisaborole Ointment (2%) Versus Tacrolimus Ointment (0.1%) for the Topical Treatment of Atopic Dermatitis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003876', 'term': 'Dermatitis, Atopic'}], 'ancestors': [{'id': 'D012873', 'term': 'Skin Diseases, Genetic'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D003872', 'term': 'Dermatitis'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D017443', 'term': 'Skin Diseases, Eczematous'}, {'id': 'D006969', 'term': 'Hypersensitivity, Immediate'}, {'id': 'D006967', 'term': 'Hypersensitivity'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C543085', 'term': 'crisaborole'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 148}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-03-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2026-08-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-26', 'studyFirstSubmitDate': '2026-02-22', 'studyFirstSubmitQcDate': '2026-02-22', 'lastUpdatePostDateStruct': {'date': '2026-03-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-04-25', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'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.', 'timeFrame': '8 weeks', 'description': '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.\n\nThe SCORAD score combines objective signs and subjective symptoms into a single score (0-103).\n\nObjective Signs (A) - Extent (0-100) and Intensity(0-18) Subjective Symptoms (C) - Itch and Sleeplessness\n\nEach is scored by the patient (or caregiver) on a visual analog scale (VAS) from 0 to 10:\n\nSCORAD} = \\\\frac{A}{5} + 7 \\\\times \\\\frac{B}{2} + C\n\nWhere:\n\nA = 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.\n\nMinimum value:0 Maximum value:103'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Atopic Dermatitis']}, 'descriptionModule': {'briefSummary': "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.\n\nIn 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.\n\nCurrent Treatments and Their Problems\n\nThe standard treatment includes:\n\nMoisturizers - Help repair the skin barrier. Topical Steroids (creams/ointments) - Reduce inflammation but can thin the skin if used too long.\n\nSteroid-Free Alternatives - Used to avoid steroid side effects.\n\nTwo key steroid-free options are:\n\nTacrolimus (0.1% ointment) - Works well for moderate-to-severe eczema but can cause burning, itching, and has a \\*\\*cancer risk warning (though rare).\n\nCrisaborole (2% ointment) - A newer treatment for mild-to-moderate eczema, with fewer side effects but less research on its long-term use.\n\nWhy This Study is Needed\n\nMost research on these treatments comes from Western countries, and Pakistani patients may respond differently due to:\n\nClimate\\* (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.\n\nWhat This Study Will Do\n\nThis research will \\*compare tacrolimus 0.1% and crisaborole 2% in Pakistani patients with eczema to see:\n\nWhich 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\n\nPatients (adults and children over 2 years) with mild-to-moderate eczema will be divided into two groups:\n\nOne 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.\n\nWhy 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"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '2 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n\\* Patients aged ≥2 years of either gender.\n\nDiagnosed with mild to moderate atopic dermatitis based on Hanifin and Rajka criteria.\n\nSCORAD score between 15 and 40. Willing to participate and provide informed consent (from guardian for minors).\n\nExclusion Criteria:\n\n\\-\n\nExclusion Criteria:\n\n\\* Severe atopic dermatitis (SCORAD \\> 40).\n\nHistory 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.\n\n\\-'}, 'identificationModule': {'nctId': 'NCT07437534', 'briefTitle': 'Comparative Evaluation of the Safety and Effectiveness of Crisaborole Ointment (2%) Versus Tacrolimus Ointment (0.1%) for the Topical Treatment of Atopic Dermatitis', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Hayat Abad Medical Complex, Peshawar'}, 'officialTitle': 'Comparative Evaluation of the Safety and Effectiveness of Crisaborole Ointment (2%) Versus Tacrolimus Ointment (0.1%) for the Topical Treatment of Atopic Dermatitis', 'orgStudyIdInfo': {'id': 'Hayatabad Medical Complex'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Crisaborole Ointment 2%', 'description': 'crisaborole is a Phosphodiesterase 4 inhibitor approved for the topical treament of atopic dermatitis', 'interventionNames': ['Drug: Crisaborole 2% Topical Application Ointment [EUCRISA']}, {'type': 'EXPERIMENTAL', 'label': 'Tacrolimus 0.1%', 'description': 'Topical tacrolimus, used to treat atopic dermatitis, works by inhibiting T-cell activation and cytokine production.', 'interventionNames': ['Drug: tacrolimus 0.1%']}], 'interventions': [{'name': 'Crisaborole 2% Topical Application Ointment [EUCRISA', 'type': 'DRUG', 'description': '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', 'armGroupLabels': ['Crisaborole Ointment 2%']}, {'name': 'tacrolimus 0.1%', 'type': 'DRUG', 'description': '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', 'armGroupLabels': ['Tacrolimus 0.1%']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Peshawar', 'state': 'KPK', 'country': 'Pakistan', 'contacts': [{'name': 'Dr Ayesha Ahsan, MBBS,FCPS 1', 'role': 'CONTACT', 'email': 'ayeshaareebaihsan@gmail.com', 'phone': '03101188666'}], 'facility': 'Hayatabad Medical Complex', 'geoPoint': {'lat': 34.008, 'lon': 71.57849}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hayat Abad Medical Complex, Peshawar', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Trainee Medical Officer', 'investigatorFullName': 'Syeda Sana Zaman', 'investigatorAffiliation': 'Hayat Abad Medical Complex, Peshawar'}}}}