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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
120
Topical treatment for 24 weeks
Topical treatment for 24 weeks
Topical treatment for 24 weeks
Dr Rodney Sinclair Pty Ltd,
East Melbourne, Victoria, Australia
Dr Rodney Sinclair Pty Ltd,
Pascoe Vale South, Victoria, Australia
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
Time frame: 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.
Time frame: 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.
Time frame: 28 weeks
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
Time frame: 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
Time frame: 28 weeks
Frequency of scores for pigmentation changes compared to non-treated area of scalp and hair through study day 194
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Topical treatment for 24 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 24 weeks