Ignite Creation Date:
2025-12-24 @ 7:03 PM
Ignite Modification Date:
2026-02-24 @ 8:51 AM
Study NCT ID:
NCT05587257
Status:
UNKNOWN
Last Update Posted:
2022-10-20
First Post:
2022-10-16
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Role of Minoxidil in Alopecia Areata Transepidermal Drug Delivery of Minoxidil Via Either Fractional Carbon Dioxide Laser or Microneedling Versus Its Topical Nanoparticles Preparation for Treatment of Alopecia Areata
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000506', 'term': 'Alopecia Areata'}], 'ancestors': [{'id': 'D000505', 'term': 'Alopecia'}, {'id': 'D007039', 'term': 'Hypotrichosis'}, {'id': 'D006201', 'term': 'Hair Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D004304', 'term': 'Dosage Forms'}], 'ancestors': [{'id': 'D004364', 'term': 'Pharmaceutical Preparations'}, {'id': 'D013678', 'term': 'Technology, Pharmaceutical'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2023-01-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-10', 'completionDateStruct': {'date': '2024-02-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-10-16', 'studyFirstSubmitDate': '2022-10-16', 'studyFirstSubmitQcDate': '2022-10-16', 'lastUpdatePostDateStruct': {'date': '2022-10-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-10-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-01-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Regrowth scale', 'timeFrame': '6 months', 'description': '0 score (regrowth \\< 10%) no response\n\nscore (regrowth 11-25%) poor response score (regrowth 26-50%) fair response score (regrowth 51-75%) satisfactory response score (regrowth ≥ 75%) excellent response'}, {'measure': 'Mcdonald Hull and Norris Regrowth Scale (by trichoscope', 'timeFrame': '6 months', 'description': 'Grade 1 - Regrowth of vellus hair. Grade 2 - Regrowth of sparse pigmented terminal hair. Grade 3 - Regrowth of terminal hair with patches of alopecia with patches of alopecia 50-75% in SALT score.\n\nGrade 4 - Regrowth of terminal hair on scalp with patches of alopecia \\> 75% in SALT score.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Alopecia Areata']}, 'descriptionModule': {'briefSummary': '* Compare the clinical efficacy, and safety of transepidermal drug delivery of fractional CO2 laser versus microneedling followed by minoxidil 5% application for the treatment of alopecia areata.\n* Evaluate the efficacy, and safety of minoxidil nanoparticles as a topical treatment of alopecia areata.', 'detailedDescription': 'Alopecia areata (AA) is the most common cause of non-scarring alopecia. (Hordinsky, 2013).\n\nAlthough many patients improve spontaneously or respond to standard therapy, in patients with more severe and refractory disease, management can be quite challenging (Messenger et al., 2012 and Kranseler and Sidbury, 2017).\n\nCorticosteroids either topical or intralesional are the most popular medications used to treat this condition. Other therapies such as topical minoxidil (MXD), anthralin, immunotherapy, systemic corticosteroids are also commonly used with variable success (Shumez et al., 2015).\n\nPatients treated with MXD 5% have significant hair growth than placebo. Minoxidil was more effective for patchy alopecia than other types of AA such as ophiasis and alopecia totalis. It was ineffective in alopecia universalis (El-Taib et al., 2017).\n\nIn contrast, the incidence of adverse events associated with 10% MXD treatment was higher than with 5% MXD treatment. Therefore, new approaches are required to achieve both expected efficacy and safety (Oaku et al., 2022).\n\nThe combination of non-ablative laser and topical MXD can be a good alternative therapy for AA patients, including alopecia totalis and alopecia universalis, without systemic and local side effects (Wang et al., 2019) According to follicle deposition and diffusion experiments, minoxidil nanoemulsions penetrated hair follicles 26 times more efficiently than standard treatment (Cardoso and Barradas, 2020).\n\nTo the best our knowledge no previous research studied the effect of nanominoxidil solution in treatment of AA except in animal or compare transepidermal drug delivery versus topical nanominoxidil.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '50 Years', 'minimumAge': '10 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* The study will include patients with alopecia areata\n\nExclusion Criteria:\n\n* Children below 18 years , pregnant and lactating women . patients with chronic hepatic, hematological disorders or immunocompromised patients.\n\npatient recieved any treatment for alopecia areata in the last 3 months before the study.\n\npatients with extensive types (alopecia totalis, universalis and surface area \\>50%).'}, 'identificationModule': {'nctId': 'NCT05587257', 'briefTitle': 'Role of Minoxidil in Alopecia Areata Transepidermal Drug Delivery of Minoxidil Via Either Fractional Carbon Dioxide Laser or Microneedling Versus Its Topical Nanoparticles Preparation for Treatment of Alopecia Areata', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'Transepidermal Drug Delivery of Minoxidil Via Either Fractional Carbon Dioxide Laser or Microneedling Versus Its Topical Nanoparticles Preparation for Treatment of Alopecia Areata', 'orgStudyIdInfo': {'id': 'Minoxidil in alopecia areata'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group 1', 'description': 'six sessions of fractional carbon dioxide laser every 2 weeks will be done for 15 patients with alopecia areata followed immediately by topical application of minoxidil 5%', 'interventionNames': ['Device: Fractional CO2 laser']}, {'type': 'EXPERIMENTAL', 'label': 'Group 2', 'description': 'six sessions of microneedling evry 2 weeks will be done for 15 patients with alopecia areata followed immediately by topical application of minoxidil 5%', 'interventionNames': ['Device: Derma pen']}, {'type': 'EXPERIMENTAL', 'label': 'Group 3', 'description': '15 patient of alopecia areata that will be treated by topical nanominoxidil for 3 months.', 'interventionNames': ['Drug: Niosome minoxidil']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group 4', 'description': '15 patient of alopecia areata that will be treated by topical minoxidil 5% for 3 months', 'interventionNames': ['Drug: Minoxidil Topical Spray']}], 'interventions': [{'name': 'Fractional CO2 laser', 'type': 'DEVICE', 'otherNames': ['Drug'], 'description': 'Each patient will receive 6 sessions 2 weeks apart, after the laser treatment, a topical 5% minoxidil tincture will immediately applied.\n\nAll patients will advised not to use any other treatment during the study', 'armGroupLabels': ['Group 1']}, {'name': 'Derma pen', 'type': 'DEVICE', 'otherNames': ['Drug'], 'description': ', will be treated by microneedling using dermapen ( automated Derma Pen, DR Pen Ultima A6, China) which under complete aseptic precaution with a cartridge containing 12 needles moved diagonally, vertically, and horizontally for 4-5 times in each direction with 1.5 mm depth and speed 4-5(new cartridge every session), the application has been extended 1-2 cm perilesionally. The pinpoint bleeding will be considered an endpoint. topical 5% minoxidil tincture will immediately applied. Each patient will receive 6 sessions 2 weeks apart.', 'armGroupLabels': ['Group 2']}, {'name': 'Niosome minoxidil', 'type': 'DRUG', 'description': 'The patient of alopecia areata will be treated by topical nanominoxidil preparation twice daily for 3 months with no other treatment.', 'armGroupLabels': ['Group 3']}, {'name': 'Minoxidil Topical Spray', 'type': 'DRUG', 'description': 'The patient of alopecia areata will be treated by topical minoxidil 5% preparation twice daily for 3 months with no other treatment.', 'armGroupLabels': ['Group 4']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Ahmed Elsayed, Master', 'role': 'CONTACT', 'email': 'Ahmed.alsaid@med.aun.eg', 'phone': '+20 1000520295'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Lecturer', 'investigatorFullName': 'Ahmed Elsayed Mohamed', 'investigatorAffiliation': 'Assiut University'}}}}