Ignite Creation Date:
2025-12-24 @ 10:12 PM
Ignite Modification Date:
2026-01-15 @ 3:33 PM
Study NCT ID:
NCT03834935
Status:
UNKNOWN
Last Update Posted:
2019-02-11
First Post:
2019-02-06
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy of Topical Pimecrolimus in the Treatment of Pityriasis Alba
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D063807', 'term': 'Dandruff'}], 'ancestors': [{'id': 'D003872', 'term': 'Dermatitis'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D012536', 'term': 'Scalp Dermatoses'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C117268', 'term': 'pimecrolimus'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'investigators and patients will be blinded to treatment'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2019-03-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-02', 'completionDateStruct': {'date': '2021-04-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-02-07', 'studyFirstSubmitDate': '2019-02-06', 'studyFirstSubmitQcDate': '2019-02-07', 'lastUpdatePostDateStruct': {'date': '2019-02-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-02-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-02-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of repigmentation of index lesions', 'timeFrame': '9 weeks', 'description': 'Objective percentage of repigmentation the index lesion (the largest lesion) by image analysis software (ImageJ software will be used to measure the lesion reduction area after treatments)'}], 'secondaryOutcomes': [{'measure': 'Pruritus and scaling', 'timeFrame': '3,6 and 9 weeks', 'description': 'IGA 4 point-scale (0: none - 3: severe)'}, {'measure': "Investigator's repigmentation change", 'timeFrame': '3,6 and 9 weeks', 'description': 'Clinical change is assessed by means of digital photographic registration (frontal, right, and left views). An independent observer clinically graded the global improvement as poor (0-25%), mild (26-50%), good (51-75%), and excellent (\\>75%).'}, {'measure': 'patient satisfaction', 'timeFrame': '9 weeks', 'description': '(0: not satisfied, 1: satisfied, 2: very satisfied).'}, {'measure': 'Adverse events', 'timeFrame': '3,6 and 9 weeks', 'description': 'adverse events reporting'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['pityriasis alba', 'treatment', 'topical calcineurin inhibitor'], 'conditions': ['Pityriasis Alba']}, 'descriptionModule': {'briefSummary': 'Pityriasis alba (PA) is a common benign skin disorder, that usually affects children and adolescents of darker phototypes. A history of atopic dermatitis is a well-known risk factor, and PA may be a minor manifestation of atopic dermatitis, although it can occur in nonatopic individuals as well. The objective is to evaluate the effect of topical pimecrolimus in the treatment of treatment of PA', 'detailedDescription': 'Background and Rationale:\n\nPityriasis alba (PA) is a common benign skin disorder, that usually affects children and adolescents of darker phototypes. PA usually manifests as erythematous lesions followed by smooth scales with residual characteristic pruritic or non-pruritic ill-defined hypopigmented patches, that typically occur on the upper part of the body, especially the face. A history of atopic dermatitis is a well-known risk factor, and PA may be a minor manifestation of atopic dermatitis, although it can occur in nonatopic individuals as well. It is thought to represent nonspecific dermatitis with residual post-inflammatory hypopigmentation. Sun exposure is a triggering and accentuating factor.\n\nPA is a common reason for dermatologic consultation due to its chronic course, frequent relapses and cosmetic appearance. Spontaneous healing occurs in several months to few years, therefore impacting the quality of life. Emollients and mild-potency topical steroids are the mainstay of treatment, with a potential risk of skin atrophy and hypopigmentation.\n\nPimecrolimus is a topical calcineurin inhibitor that prevents T-cell activation, approved for the treatment of atopic dermatitis, and proved efficacious for seborrheic dermatitis, without having the potential adverse effects of topical corticosteroids. Tacrolimus 0.1% ointment, another calcineurin inhibitor is an effective and safe treatment for PA, a similar efficacy of calcitriol and tacrolimus was shown after 9 weeks of treatment. An exploratory study evaluated the efficacy of pimecrolimus cream in the treatment of PA. To the best of our knowledge there is no randomized placebo-controlled trial in the literature proving the efficacy of pimecrolimus in PA.\n\nObjective: To evaluate the effect of topical pimecrolimus in the treatment of treatment of PA\n\nHypothesis: Pimecrolimus is an efficacious, well-tolerated and safe treatment for pityriasis alba.\n\nTrial design: A randomized placebo-controlled double blinded trial establishing the superiority of topical pimecrolimus 1% over placebo.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '2 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Pityriasis alba Patients confirmed by a board certified dermatologist\n* Age over 2 years\n* Written informed consent signed by the patients or the legal guardians of patients younger than 18 years in the native language (Arabic)\n\nExclusion Criteria:\n\n* Other concomitant dermatosis (except atopic dermatitis)\n* Use of topical steroids, or topical agents other than emollients and sunscreen, in the last 4 weeks\n* Known allergy to pimecrolimus\n* Pregnant and nursing women'}, 'identificationModule': {'nctId': 'NCT03834935', 'briefTitle': 'Efficacy of Topical Pimecrolimus in the Treatment of Pityriasis Alba', 'organization': {'class': 'OTHER', 'fullName': 'St Joseph University, Beirut, Lebanon'}, 'officialTitle': 'Efficacy of Topical Pimecrolimus in the Treatment of Pityriasis Alba: A Randomized Placebo-controlled Trial', 'orgStudyIdInfo': {'id': 'USJDERM1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Pim', 'description': '20 patients receiving topical Elidel (pimecrolimus 1%) bid on the affected area for 9 weeks.Sunscreens will not be indicated, and hygienic habits will not be changed.', 'interventionNames': ['Drug: Elidel (pimecrolimus 1%)']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Pl', 'description': '20 patients receiving placebo (control group), cold cream bid on the affected area for 9 weeks.Sunscreens will not be indicated, and hygienic habits will not be changed.', 'interventionNames': ['Drug: Cold Cream']}], 'interventions': [{'name': 'Elidel (pimecrolimus 1%)', 'type': 'DRUG', 'description': 'topical application of product on all lesions, twice daily. Sunscreen will not be indicated, and hygienic habits will not be changed', 'armGroupLabels': ['Pim']}, {'name': 'Cold Cream', 'type': 'DRUG', 'description': 'Topical application on all lesions, twice daily. Sunscreen will not be indicated, and hygienic habits will not be changed', 'armGroupLabels': ['Pl']}]}, 'contactsLocationsModule': {'locations': [{'zip': '166830', 'city': 'Beirut', 'country': 'Lebanon', 'contacts': [{'name': 'elio kechichian', 'role': 'CONTACT', 'email': 'elio.kechichian@gmail.com', 'phone': '3079072'}], 'facility': 'Saint Joseph University', 'geoPoint': {'lat': 33.89332, 'lon': 35.50157}}], 'centralContacts': [{'name': 'elio G kechichian, MD', 'role': 'CONTACT', 'email': 'elio.kechichian@gmail.com', 'phone': '+9613079072'}], 'overallOfficials': [{'name': 'Josiane Helou, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Saint-Joseph University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'St Joseph University, Beirut, Lebanon', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal investigator, MD', 'investigatorFullName': 'elio kechichian', 'investigatorAffiliation': 'St Joseph University, Beirut, Lebanon'}}}}