Safety and Efficacy Study of Topical DLQ01 in the Treatment of Androgenetic Alopecia (AGA) in Men
- Conditions
- Androgenetic Alopecia
- Interventions
- Drug: prostaglandin F2a analogue in vehicle solution high doseDrug: prostaglandin F2a analogue in vehicle solution low doseDrug: active ingredient-free vehicle solution to DLQ01
- Registration Number
- NCT05636904
- Lead Sponsor
- Dermaliq Therapeutics, Inc.
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 120
- 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.
- 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.
- Willing to have target areas shaved and to have temporary dot tattoos placed on their scalp.
- Willing to comply with the study instructions and return to the site for required visits.
- 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.
- Must provide written informed consent.
- Participants with other type of alopecia other than AGA or any other concomitant skin or systemic disorder involving the scalp area.
- Participants with sensitive, irritated, or abraded scalp area.
- Participants who have undergone hair transplants or have had scalp reductions.
- Concurrent treatments or interventions that could affect interpretation of study data, prior to or during the study, as specified in the protocol
- Current evidence of another ongoing or acute relevant cutaneous infection, active systemic infection, or other significant skin conditions.
- 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.
- Known allergy or sensitivity to tattoo ink.
- Participant with relevant active or prior history of malignancies.
- Participants with relevant cardiovascular disease including ischemic heart disease, cardiac arrhythmias, or congestive heart disease.
- 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.
- Clinically significant abnormal biochemistry, haematology or urinalysis values.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description DLQ01 high dose prostaglandin F2a analogue in vehicle solution high dose Twice daily application of DLQ01 high dose cutaneous solution in 30 subjects Minoxidil Solution 5% Minoxidil 5% Topical Solution Twice daily application of the comparator cutaneous solution in 30 subjects DLQ01 low dose prostaglandin F2a analogue in vehicle solution low dose Twice daily application of DLQ01 low dose cutaneous solution in 30 subjects active ingredient-free vehicle solution to DLQ01 active ingredient-free vehicle solution to DLQ01 Twice daily application of DLQ01 vehicle cutaneous solution in 30 subjects
- Primary Outcome Measures
Name Time Method TAHC (total, terminal, and vellus) 28 weeks 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
Cumulative hair thickness density (mm/cm2) 28 weeks Change in cumulative hair thickness density using digital image analysis after 4, 12, and 24 weeks of treatment, and at the follow-up visit.
Anagen/telogen ratio 28 weeks Change in anagen/telogen ratios using digital image analysis after 4, 12, and 24 weeks of treatment, and at the follow-up visit.
- Secondary Outcome Measures
Name Time Method Investigator global assessment (IGA) using a 7-point ordinal scale compared to baseline 28 weeks 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
Number of participants with clinically significant abnormal laboratory test results 28 weeks Collection of safety blood at screening, after 24 weeks of treatment, and at follow-up
Number of participants with clinically significant abnormal blood pressure 28 weeks Collection of blood pressure at screening, baseline, and after 4, 16, and 24 weeks of treatment, and at follow-up
Frequency of scores for pigmentation changes compared to non-treated area of scalp and hair through study day 194 28 weeks 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
Number of participants with clinically significant abnormal heart rate 28 weeks Collection of heart rate at screening, baseline, and after 4, 16, and 24 weeks of treatment, and at follow-up
Number of participants with clinically significant abnormal ECG readings 28 weeks Collection of 12-lead ECG at screening, and after 4, 12, 16, and 24 weeks of treatment, and at follow-up
Frequency of scores for cutaneous reactions in the treated area through study day 194 28 weeks 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
Plasma concentrations of DLQ01 24 weeks 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
Trial Locations
- Locations (1)
Dr Rodney Sinclair Pty Ltd,
🇦🇺Pascoe Vale South, Victoria, Australia