Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DLQ01 high dose | Experimental | Twice daily application of DLQ01 high dose cutaneous solution in 30 subjects |
|
| DLQ01 low dose | Experimental | Twice daily application of DLQ01 low dose cutaneous solution in 30 subjects |
|
| active ingredient-free vehicle solution to DLQ01 | Placebo Comparator | Twice daily application of DLQ01 vehicle cutaneous solution in 30 subjects |
|
| Minoxidil Solution 5% | Active Comparator | Twice daily application of the comparator cutaneous solution in 30 subjects |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| prostaglandin F2a analogue in vehicle solution high dose | Drug | Topical treatment for 24 weeks |
|
| 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 |
| 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Betsy Hughes-Formella, PhD | Dermaliq Therapeutics, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dr Rodney Sinclair Pty Ltd, | East Melbourne | Victoria | 3002 | Australia | ||
| Dr Rodney Sinclair Pty Ltd, |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| prostaglandin F2a analogue in vehicle solution low dose | Drug | Topical treatment for 24 weeks |
|
|
| active ingredient-free vehicle solution to DLQ01 | Drug | Topical treatment for 24 weeks |
|
|
| Minoxidil 5% Topical Solution | Drug | Topical treatment for 24 weeks |
|
|
| 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 |
| Pascoe Vale South |
| Victoria |
| 3044 |
| Australia |
| ID | Term |
|---|---|
| D000505 | Alopecia |
| ID | Term |
|---|---|
| D007039 | Hypotrichosis |
| D006201 | Hair Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| D008914 | Minoxidil |
| D012996 | Solutions |
| ID | Term |
|---|---|
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D011743 | Pyrimidines |
| D004364 | Pharmaceutical Preparations |
Not provided
Not provided