Ignite Creation Date:
2025-12-24 @ 11:40 PM
Ignite Modification Date:
2025-12-25 @ 9:31 PM
Study NCT ID:
NCT03535051
Status:
COMPLETED
Last Update Posted:
2018-09-13
First Post:
2018-05-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Efficiency of Fractional-Laser Resurfacing Followed by Topical Tacrolimus 0.03% Cream vs Tacrolimus Alone in Vitiligo
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014820', 'term': 'Vitiligo'}], 'ancestors': [{'id': 'D017496', 'term': 'Hypopigmentation'}, {'id': 'D010859', 'term': 'Pigmentation Disorders'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'FACTORIAL', 'interventionModelDescription': 'A total of 152 lesions in different areas of the body were evaluated in the study. Seventy six lesions received the combination treatment and 76 received topical tacrolimus alone. Forty six lesions were in the head and neck region, 40 were acral in location, 36 were in the upper and lower limbs, 22 lesions were over bony prominences and 8 lesions were present on the trunk.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 27}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-09', 'completionDateStruct': {'date': '2017-02-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-09-11', 'studyFirstSubmitDate': '2018-05-12', 'studyFirstSubmitQcDate': '2018-05-12', 'lastUpdatePostDateStruct': {'date': '2018-09-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-05-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-01-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'repigmentation', 'timeFrame': '5 months', 'description': 'reduction in Vitiligo Area Scoring Index of lesions'}]}, 'oversightModule': {'isUsExport': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['vitiligo', 'fractional carbon dioxide laser', 'tacrolimus', 'drug delivery'], 'conditions': ['Stable Vitiligo']}, 'descriptionModule': {'briefSummary': 'The aim the clinical trial was to find out whether fractional CO₂ laser sessions in combination with application of daily topical tacrolimus 0.03% would enhance the action of the drug and pose as a possible combination treatment option for stable vitiligo lesions. This combination treatment was applied to one side of the body and the response was compared to the response of the lesions on the other side of the body to daily topical tacrolimus 0.03% alone, which was used as control.', 'detailedDescription': 'Each patient included in the study received treatment A on the lesions on one side of his/her body, and treatment B on the other side.\n\nTreatment A included 4 monthly sessions of fractional CO₂ laser on the lesions plus application of topical tacrolimus 0.03% (Tarolimus) on the lesions 6 hours after each session and twice daily in between the sessions and for 1 month after the last session.\n\nTreatment B included only the application of topical tacrolimus 0.03% (Tarolimus) on the lesions twice daily for 5 months.\n\nFractional laser The device used was DEKA, SmartXide DOT (Dermal Optical Thermolysis), Italy fractional Carbon Dioxide Laser (fig. 8). This device is an ablative fractional 10,6000 nm CO² Laser with variable pulse duration (0.2-2 ms), 350-μm beam spot size, scanner area of 15x15 mm and penetration depth between 200 to 1,500 μm.\n\nTacrolimus ointment 0.03% (Tarolimus) Applied on the lesions treated by fractional CO² laser 6 hours after each laser session, then twice daily in between the sessions and 1 month after the last session.\n\nApplied on the lesions on the other half of the body (not treated with fractional CO² laser) twice daily for 4 months.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '12 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\n* Patients with stable vitiligo for at least 6 months, stability being defined as no eruption of fresh lesions and no extension of pre-existing lesions.\n* Age ≧ 12 years.\n* Symmetrical vitiligo.\n* Three month treatment-free period.\n\nExclusion criteria:\n\n* Patients younger than 12 years of age.\n* Non-stable lesions.\n* Non-symmetrical vitiligo.\n* Patients currently on other lines of treatment.'}, 'identificationModule': {'nctId': 'NCT03535051', 'briefTitle': 'Efficiency of Fractional-Laser Resurfacing Followed by Topical Tacrolimus 0.03% Cream vs Tacrolimus Alone in Vitiligo', 'organization': {'class': 'OTHER', 'fullName': 'Kasr El Aini Hospital'}, 'officialTitle': 'The Efficiency of Fractional-Laser Resurfacing Followed by Topical Tacrolimus 0.03% Cream Versus Topical Tacrolimus Alone in Stable Vitiligo: a Comparative Study', 'orgStudyIdInfo': {'id': '2'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment A', 'description': 'Combination treatment of fractional carbon dioxide laser monthly sessions and topical tacrolimus 0.03% daily application (Tacrolimus Oint 0.03%)', 'interventionNames': ['Device: fractional carbon dioxide laser', 'Drug: Tacrolimus Oint 0.03%']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Treatment B', 'description': 'Monotherapy with only topical tacrolimus 0.03% daily intervention: Tacrolimus Oint 0.03%', 'interventionNames': ['Drug: Tacrolimus Oint 0.03%']}], 'interventions': [{'name': 'fractional carbon dioxide laser', 'type': 'DEVICE', 'otherNames': ['fractional CO2 laser'], 'description': 'Monthly fractional carbon dioxide laser sessions', 'armGroupLabels': ['Treatment A']}, {'name': 'Tacrolimus Oint 0.03%', 'type': 'DRUG', 'otherNames': ['Tacrolimus Oint 0.03% (Tarolimus)'], 'description': 'topical daily tacrolimus ointment application', 'armGroupLabels': ['Treatment A', 'Treatment B']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Ola M AbuZeid, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Kasr Al Aini dermatology department'}, {'name': 'Dina ElSharkawy, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Kasr Al Aini dermatology department'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kasr El Aini Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Resident', 'investigatorFullName': 'Nuhah Omar', 'investigatorAffiliation': 'Kasr El Aini Hospital'}}}}