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

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

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.

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.