Safety and Efficacy Study of Topical DLQ01 in the Treatment of Androgenetic Alopecia (AGA) in Men

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Androgenetic Alopecia

Intervention / Treatment
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* Drug: prostaglandin F2a analogue in vehicle solution high dose
* Drug: prostaglandin F2a analogue in vehicle solution low dose
* Drug: active ingredient-free vehicle solution to DLQ01
* Drug: Minoxidil 5% Topical Solution


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: DLQ01 high dose<br>Twice daily application of DLQ01 high dose cutaneous solution in 30 subjects | Drug: prostaglandin F2a analogue in vehicle solution high dose<br>* Topical treatment for 24 weeks<br>* Other names: DLQ01 high dose;|
| Experimental: DLQ01 low dose<br>Twice daily application of DLQ01 low dose cutaneous solution in 30 subjects | Drug: prostaglandin F2a analogue in vehicle solution low dose<br>* Topical treatment for 24 weeks<br>* Other names: DLQ01 low dose;|
| Placebo Comparator: active ingredient-free vehicle solution to DLQ01<br>Twice daily application of DLQ01 vehicle cutaneous solution in 30 subjects | Drug: active ingredient-free vehicle solution to DLQ01<br>* Topical treatment for 24 weeks<br>* Other names: DLQ01 vehicle;|
| Active Comparator: Minoxidil Solution 5%<br>Twice daily application of the comparator cutaneous solution in 30 subjects | Drug: Minoxidil 5% Topical Solution<br>* Topical treatment for 24 weeks<br>* Other names: Regaine®;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| TAHC (total, terminal, and vellus) | 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 | 28 weeks | 
| Cumulative hair thickness density (mm/cm2) | Change in cumulative hair thickness density using digital image analysis after 4, 12, and 24 weeks of treatment, and at the follow-up visit. | 28 weeks | 
| Anagen/telogen ratio | Change in anagen/telogen ratios using digital image analysis after 4, 12, and 24 weeks of treatment, and at the follow-up visit. | 28 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Investigator global assessment (IGA) using a 7-point ordinal scale compared to baseline | 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 | 28 weeks | 
| Frequency of scores for cutaneous reactions in the treated area through study day 194 | 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 | 28 weeks | 
| Frequency of scores for pigmentation changes compared to non-treated area of scalp and hair through study day 194 | 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 | 28 weeks | 
| Number of participants with clinically significant abnormal laboratory test results | Collection of safety blood at screening, after 24 weeks of treatment, and at follow-up | 28 weeks | 
| Number of participants with clinically significant abnormal heart rate | Collection of heart rate at screening, baseline, and after 4, 16, and 24 weeks of treatment, and at follow-up | 28 weeks | 
| Number of participants with clinically significant abnormal blood pressure | Collection of blood pressure at screening, baseline, and after 4, 16, and 24 weeks of treatment, and at follow-up | 28 weeks | 
| Number of participants with clinically significant abnormal ECG readings | Collection of 12-lead ECG at screening, and after 4, 12, 16, and 24 weeks of treatment, and at follow-up | 28 weeks | 
| Plasma concentrations of DLQ01 | 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 | 24 weeks |