Ignite Creation Date:
2025-12-24 @ 8:01 PM
Ignite Modification Date:
2025-12-25 @ 5:34 PM
Study NCT ID:
NCT05636904
Status:
COMPLETED
Last Update Posted:
2024-04-08
First Post:
2022-11-16
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Safety and Efficacy Study of Topical DLQ01 in the Treatment of Androgenetic Alopecia (AGA) in Men
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008914', 'term': 'Minoxidil'}, {'id': 'D012996', 'term': 'Solutions'}], 'ancestors': [{'id': 'D010880', 'term': 'Piperidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 120}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-12-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2024-03-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-04-05', 'studyFirstSubmitDate': '2022-11-16', 'studyFirstSubmitQcDate': '2022-11-24', 'lastUpdatePostDateStruct': {'date': '2024-04-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-12-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-03-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'TAHC (total, terminal, and vellus)', 'timeFrame': '28 weeks', 'description': 'Change from baseline in total, terminal, and vellus target area hair counts (TAHC) using digital image analysis after 4, 12, and 24 weeks of treatment, and at the follow-up visit'}, {'measure': 'Cumulative hair thickness density (mm/cm2)', 'timeFrame': '28 weeks', 'description': 'Change in cumulative hair thickness density using digital image analysis after 4, 12, and 24 weeks of treatment, and at the follow-up visit.'}, {'measure': 'Anagen/telogen ratio', 'timeFrame': '28 weeks', 'description': 'Change in anagen/telogen ratios using digital image analysis after 4, 12, and 24 weeks of treatment, and at the follow-up visit.'}], 'secondaryOutcomes': [{'measure': 'Investigator global assessment (IGA) using a 7-point ordinal scale compared to baseline', 'timeFrame': '28 weeks', 'description': 'Investigator assessment of the participant´s scalp hair growth compared to baseline using the following 7-point scale: greatly decreased (-3), moderately decreased (-2), slightly decreased (-1), no change (0), slightly increased (1), moderately increased (2), and greatly increased (3) compared to baseline at 4, 12, 16, and 24 weeks of treatment, and at the follow-up visit'}, {'measure': 'Frequency of scores for cutaneous reactions in the treated area through study day 194', 'timeFrame': '28 weeks', 'description': 'Investigator assessment of cutaneous reactions such as erythema, oedema, glazing with fissures, vesicles, or papules, by grading with a clinical 5-point scale: no irritation (0), mild (1), moderate (2), severe (3), and very severe (4) at each visit through study day 194'}, {'measure': 'Frequency of scores for pigmentation changes compared to non-treated area of scalp and hair through study day 194', 'timeFrame': '28 weeks', 'description': 'Investigator assessment of pigmentation changes compared to non-treated area of scalp and hair by grading with a clinical 4-point scale: no difference (0), slight difference, \\<25% (1), moderate difference, \\<50 to 75% (2), significantly darker/lighter, \\<75 to 100% (3) at each visit through study day 194'}, {'measure': 'Number of participants with clinically significant abnormal laboratory test results', 'timeFrame': '28 weeks', 'description': 'Collection of safety blood at screening, after 24 weeks of treatment, and at follow-up'}, {'measure': 'Number of participants with clinically significant abnormal heart rate', 'timeFrame': '28 weeks', 'description': 'Collection of heart rate at screening, baseline, and after 4, 16, and 24 weeks of treatment, and at follow-up'}, {'measure': 'Number of participants with clinically significant abnormal blood pressure', 'timeFrame': '28 weeks', 'description': 'Collection of blood pressure at screening, baseline, and after 4, 16, and 24 weeks of treatment, and at follow-up'}, {'measure': 'Number of participants with clinically significant abnormal ECG readings', 'timeFrame': '28 weeks', 'description': 'Collection of 12-lead ECG at screening, and after 4, 12, 16, and 24 weeks of treatment, and at follow-up'}, {'measure': 'Plasma concentrations of DLQ01', 'timeFrame': '24 weeks', 'description': 'Blood samples for evaluation of plasma concentrations of active ingredient and novel excipient will be taken at baseline (predose) and after 4, 12 and 24 weeks of treatment'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Androgenetic Alopecia']}, 'descriptionModule': {'briefSummary': 'The goal of this study is to measure the safety, tolerability, and the hair growth response to topical DLQ01 solutions in comparison to the vehicle and a comparator solution in 120 males with Androgenetic Alopecia.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Males with active AGA on the vertex area of the scalp consistent with Norwood-Hamilton Grades of IIIv through V, excluding IIIa, IVa, and Va grades.\n* Willing to maintain the same hair style, approximate length, and hair colour throughout the duration of the study as documented in the global photograph at Day -2 of baseline.\n* Willing to have target areas shaved and to have temporary dot tattoos placed on their scalp.\n* Willing to comply with the study instructions and return to the site for required visits.\n* Must be willing and able to communicate and participate in the entire study and willing to use an electronic diary to record investigational product dosing.\n* Must provide written informed consent.\n\nExclusion Criteria:\n\n* Participants with other type of alopecia other than AGA or any other concomitant skin or systemic disorder involving the scalp area.\n* Participants with sensitive, irritated, or abraded scalp area.\n* Participants who have undergone hair transplants or have had scalp reductions.\n* Concurrent treatments or interventions that could affect interpretation of study data, prior to or during the study, as specified in the protocol\n* Current evidence of another ongoing or acute relevant cutaneous infection, active systemic infection, or other significant skin conditions.\n* History of relevant sensitivity to any of the study products, or components thereof, or a history of drug or other allergy that contraindicates study participation.\n* Known allergy or sensitivity to tattoo ink.\n* Participant with relevant active or prior history of malignancies.\n* Participants with relevant cardiovascular disease including ischemic heart disease, cardiac arrhythmias, or congestive heart disease.\n* History of any relevant alcoholism, substance or drug abuse-related disorders in the past year or a positive toxicology screening panel, or alcohol breath test at Screening.\n* Clinically significant abnormal biochemistry, haematology or urinalysis values.\n* Any other relevant serious illness or medical, physical, or psychiatric condition(s) that, could interfere with full participation in the study, pose a significant risk to the participant; or interfere with interpretation of study data.'}, 'identificationModule': {'nctId': 'NCT05636904', 'briefTitle': 'Safety and Efficacy Study of Topical DLQ01 in the Treatment of Androgenetic Alopecia (AGA) in Men', 'organization': {'class': 'INDUSTRY', 'fullName': 'Dermaliq Therapeutics, Inc.'}, 'officialTitle': 'A Proof-Of-Concept Phase 1b/2a Randomized, Vehicle, and Comparator-Controlled Study of Topical DLQ01 to Assess the Safety and Efficacy in the Treatment of Androgenetic Alopecia (AGA) in Men', 'orgStudyIdInfo': {'id': 'DLQ01-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'DLQ01 high dose', 'description': 'Twice daily application of DLQ01 high dose cutaneous solution in 30 subjects', 'interventionNames': ['Drug: prostaglandin F2a analogue in vehicle solution high dose']}, {'type': 'EXPERIMENTAL', 'label': 'DLQ01 low dose', 'description': 'Twice daily application of DLQ01 low dose cutaneous solution in 30 subjects', 'interventionNames': ['Drug: prostaglandin F2a analogue in vehicle solution low dose']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'active ingredient-free vehicle solution to DLQ01', 'description': 'Twice daily application of DLQ01 vehicle cutaneous solution in 30 subjects', 'interventionNames': ['Drug: active ingredient-free vehicle solution to DLQ01']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Minoxidil Solution 5%', 'description': 'Twice daily application of the comparator cutaneous solution in 30 subjects', 'interventionNames': ['Drug: Minoxidil 5% Topical Solution']}], 'interventions': [{'name': 'prostaglandin F2a analogue in vehicle solution high dose', 'type': 'DRUG', 'otherNames': ['DLQ01 high dose'], 'description': 'Topical treatment for 24 weeks', 'armGroupLabels': ['DLQ01 high dose']}, {'name': 'prostaglandin F2a analogue in vehicle solution low dose', 'type': 'DRUG', 'otherNames': ['DLQ01 low dose'], 'description': 'Topical treatment for 24 weeks', 'armGroupLabels': ['DLQ01 low dose']}, {'name': 'active ingredient-free vehicle solution to DLQ01', 'type': 'DRUG', 'otherNames': ['DLQ01 vehicle'], 'description': 'Topical treatment for 24 weeks', 'armGroupLabels': ['active ingredient-free vehicle solution to DLQ01']}, {'name': 'Minoxidil 5% Topical Solution', 'type': 'DRUG', 'otherNames': ['Regaine®'], 'description': 'Topical treatment for 24 weeks', 'armGroupLabels': ['Minoxidil Solution 5%']}]}, 'contactsLocationsModule': {'locations': [{'zip': '3002', 'city': 'East Melbourne', 'state': 'Victoria', 'country': 'Australia', 'facility': 'Dr Rodney Sinclair Pty Ltd,', 'geoPoint': {'lat': -37.81667, 'lon': 144.9879}}, {'zip': '3044', 'city': 'Pascoe Vale South', 'state': 'Victoria', 'country': 'Australia', 'facility': 'Dr Rodney Sinclair Pty Ltd,', 'geoPoint': {'lat': -37.73973, 'lon': 144.94615}}], 'overallOfficials': [{'name': 'Betsy Hughes-Formella, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Dermaliq Therapeutics, Inc.'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Dermaliq Therapeutics, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}