Ignite Creation Date:
2026-03-26 @ 3:19 PM
Ignite Modification Date:
2026-03-31 @ 3:39 PM
Study NCT ID:
NCT07433933
Status:
COMPLETED
Last Update Posted:
2026-02-27
First Post:
2026-02-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Study to Evaluate Effect of Shampoo in Subjects With Hair Loss.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000505', 'term': 'Alopecia'}], 'ancestors': [{'id': 'D007039', 'term': 'Hypotrichosis'}, {'id': 'D006201', 'term': 'Hair Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2025-02-04', 'size': 152423, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2026-02-19T10:57', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2025-05-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2025-10-16', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2026-02-25', 'studyFirstSubmitDate': '2026-02-19', 'studyFirstSubmitQcDate': '2026-02-19', 'lastUpdatePostDateStruct': {'date': '2026-02-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-10-16', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in hair lenght and thickness', 'timeFrame': 'From baseline to the end of use at 3 months.'}], 'secondaryOutcomes': [{'measure': 'Change in hair lenght and thickness at 1 month', 'timeFrame': 'Baseline and 1 month of use'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Telogen Effluvium', 'Androgenetic Alopecia']}, 'descriptionModule': {'briefSummary': 'The goal of this observational study is to learn about the effects of anti-hair loss shampoo in subjects over the age of 18 who use shampoo to treat their hair loss caused by telogen effluvium (TE) and androgenetic alopecia (AGA). The main question it aims to answer is:\n\n• Does a shampoo use help to reduce the visible signs of hair loss related to TE and AGA?\n\nSubjects will use the shampoo for 3 months and visit the clinic for the visits established by the protocol.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Clinic database', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Sex: Both (50% women; 50% men).\n* Age: 18-65 years.\n* Subjects with hair loss due to telogen effluvium or mild or incipient androgenic alopecia, in an 80/20 ratio.\n* Degree of androgenic alopecia: Ludwig scale score I-II for women and Hamilton-Norwood scale score III-II for men.\n* Telogen effluvium: Combing test.\n* Subjects with all hair types (oily, combination, sensitive, etc.).\n* Subjects with all scalp types (normal, sensitive, etc.).\n* Agree to participate voluntarily in the study and provide written informed consent.\n* Adequate level of understanding of the clinical study.\n* Good health (physical and mental).\n* Availability to attend visits to the research centres.\n* No application of any product to the experimental area on the first day of the trial.\n\nExclusion Criteria:\n\n* Individuals under 18 years of age.\n* Pregnant or breastfeeding women.\n* Injuries or infection in the test area.\n* History of allergies to cosmetic products.\n* Known allergies to product components.\n* Sensitivity to any product component.\n* Patients who have undergone recent surgery or treatments in the study area.\n* Cancer patients.\n* Volunteers currently taking antibiotics, antihistamines, corticosteroids, beta-blockers, retinoids, azelaic acid, or acne therapies, or whose treatment ended within 15 days prior to the start of the study. Participation in another clinical study.\n* Use of or having used cosmetic products and/or oral or topical treatments for hair loss for at least 6 months.\n* Hair cutting or dyeing during the study.\n* Health problems, to be assessed by the specialist, that may compromise adherence to the study protocol.'}, 'identificationModule': {'nctId': 'NCT07433933', 'briefTitle': 'Clinical Study to Evaluate Effect of Shampoo in Subjects With Hair Loss.', 'organization': {'class': 'INDUSTRY', 'fullName': 'Lacer S.A.'}, 'officialTitle': 'Clinical Study to Evaluate the Efficacy and Safety of a Cosmetic Product in Subjects With Telogen Effluvium and Androgenic Alopecia', 'orgStudyIdInfo': {'id': 'LACER_2406_COS'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'anti-hair loss shampoo', 'interventionNames': ['Other: anti-hair loss shampoo']}], 'interventions': [{'name': 'anti-hair loss shampoo', 'type': 'OTHER', 'description': 'anti-hair loss shampoo use for 3 months', 'armGroupLabels': ['anti-hair loss shampoo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '28805', 'city': 'Alcalá de Henares', 'state': 'Madrid', 'country': 'Spain', 'facility': 'Centro Médico Complutense Grupo Virtus', 'geoPoint': {'lat': 40.48205, 'lon': -3.35996}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Only summary of the results to support the publication will be shared. No complete study documents will shared.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Lacer S.A.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}