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

Androgenetic Alopecia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05636904
• Other study ID #: DLQ01-001
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: December 5, 2022
• Est. completion date: March 28, 2024

Study information

• Verified date: April 2024
• Source: Dermaliq Therapeutics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: March 28, 2024
• Est. primary completion date: March 28, 2024
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Alopecia
• Alopecia Areata
• Androgenetic Alopecia

Intervention

Drug:
• prostaglandin F2a analogue in vehicle solution high dose
Topical treatment for 24 weeks
• prostaglandin F2a analogue in vehicle solution low dose
Topical treatment for 24 weeks
• active ingredient-free vehicle solution to DLQ01
Topical treatment for 24 weeks
• Minoxidil 5% Topical Solution
Topical treatment for 24 weeks

Locations

Country	Name	City	State
Australia	Dr Rodney Sinclair Pty Ltd,	East Melbourne	Victoria
Australia	Dr Rodney Sinclair Pty Ltd,	Pascoe Vale South	Victoria

Sponsors (1)

Lead Sponsor	Collaborator
Dermaliq Therapeutics, Inc.

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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