Ignite Creation Date:
2025-12-24 @ 4:54 PM
Ignite Modification Date:
2025-12-24 @ 4:54 PM
Study NCT ID:
NCT06648850
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-05-23
First Post:
2024-10-17
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Clinical Study of DA-001 as a Treatment for Telogen Effluvium
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D010656', 'term': 'Phenylephrine'}], 'ancestors': [{'id': 'D004983', 'term': 'Ethanolamines'}, {'id': 'D000605', 'term': 'Amino Alcohols'}, {'id': 'D000438', 'term': 'Alcohols'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000588', 'term': 'Amines'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 480}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-10-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2026-04-17', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-05-22', 'studyFirstSubmitDate': '2024-10-17', 'studyFirstSubmitQcDate': '2024-10-17', 'lastUpdatePostDateStruct': {'date': '2025-05-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-10-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-02-16', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Hairs Shedding', 'timeFrame': 'Minutes [0,5]', 'description': 'Number of hairs shedding during brushing at target area'}], 'secondaryOutcomes': [{'measure': 'Number of Hairs Shedding', 'timeFrame': 'Week [0,4]', 'description': 'Number of hairs shedding during brushing at target area'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Hair Shedding'], 'conditions': ['Telogen Effluvium']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.danielalain.com', 'label': 'Daniel Alain, Inc. - Updated Study Information'}]}, 'descriptionModule': {'briefSummary': 'The primary objective of the study is to assess the safety and efficacy of DA-001 as a treatment for telogen effluvium', 'detailedDescription': 'DA-001 is a topical alpha 1 agonist combined with a TAAR receptor agonist. DA-001 was studied in a population of women that suffer from excessive hair shedding. DA-001 demonstrated significant reduction in hair shedding.\n\nThis study aims to assess the safety and efficacy of DA-001 as a treatment for telogen effluvium.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': 'Females', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 18 or older\n* Diagnosed with telogen effluvium\n* Willing and able to apply the treatment as directed, comply with study\n* Otherwise healthy\n* Able to give informed consent\n\nExclusion Criteria:\n\n* A medical history that may interfere with study objectives\n* Women who are pregnant, lactating, or planning to become pregnant during the study period\n* Subjects who have experienced a clinically important medical event within 90 days of the visit (e.g., stroke, myocardial infarction, etc)\n* Subjects who have known allergies to any excipient in DA-001\n* Subjects who are currently participating in another clinical study or have completed another clinical study with an investigational drug or device in the treatment area within 30 days prior to study treatment initiation\n* Subjects who have used any topical prescription medications in the treatment area within 30 days prior to study treatment initiation\n* Subjects who have had a dermatological procedure such as surgery in the treatment area within 30 days prior to study treatment initiation\n* Subject is unable to provide consent or make the allotted clinical visits'}, 'identificationModule': {'nctId': 'NCT06648850', 'briefTitle': 'Clinical Study of DA-001 as a Treatment for Telogen Effluvium', 'organization': {'class': 'INDUSTRY', 'fullName': 'Applied Biology, Inc.'}, 'officialTitle': 'Clinical Study of DA-001 as a Treatment for Telogen Effluvium', 'orgStudyIdInfo': {'id': 'DA-001-TE'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'DA-001', 'description': 'Phenylephrine + Alpha 1 Agonist + TAAR Agonist', 'interventionNames': ['Drug: DA-001']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo', 'interventionNames': ['Other: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Phenylephrine', 'description': 'Phenylephrine', 'interventionNames': ['Drug: Phenylephrine']}, {'type': 'EXPERIMENTAL', 'label': 'Intact5', 'description': 'Cosmetic formulation containing bitter orange extract', 'interventionNames': ['Other: Intact5']}], 'interventions': [{'name': 'DA-001', 'type': 'DRUG', 'description': 'Phenyephrine + Alpha 1 Agonist (GRAS) + TAAR Agonist (GRAS) Topical Solution', 'armGroupLabels': ['DA-001']}, {'name': 'Placebo', 'type': 'OTHER', 'description': 'Placebo Topical Solution', 'armGroupLabels': ['Placebo']}, {'name': 'Phenylephrine', 'type': 'DRUG', 'description': 'Phenylephrine Topical Solution', 'armGroupLabels': ['Phenylephrine']}, {'name': 'Intact5', 'type': 'OTHER', 'description': 'Cosmetic formulation containing bitter orange extract', 'armGroupLabels': ['Intact5']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Andy Goren, MD', 'role': 'CONTACT', 'email': 'clinicalstudies@appliedbiology.com', 'phone': '16507040850'}], 'overallOfficials': [{'name': 'Andy Goren, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University of Rome G. Marconi'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Applied Biology, Inc.', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Follea International Limited', 'class': 'INDUSTRY'}, {'name': 'Daniel Alain, Inc.', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}