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

• Status: Not yet recruiting
• Trial end date: 2024-03-01
• Target enrollment: 0
• Participant gender: Male

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Dermaliq Therapeutics, Inc.
• Treatments: Dinoprost; Dinoprost tromethamine; Minoxidil; Pharmaceutical Solutions

Criteria

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.