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

Dermaliq Therapeutics

Status and phase: Completed; Phase 2; Phase 1

Conditions: Androgenetic Alopecia

Treatments: Drug: active ingredient-free vehicle solution to DLQ01; Drug: prostaglandin F2a analogue in vehicle solution low dose; Drug: prostaglandin F2a analogue in vehicle solution high dose; Drug: Minoxidil 5% Topical Solution

Study type: Interventional

Funder types: Industry

Identifiers

NCT05636904

DLQ01-001

Details and patient eligibility

About

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.

Enrollment: 120 patients

Sex: Male

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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120 participants in 4 patient groups, including a placebo group

DLQ01 high dose

Experimental group

Description:

Twice daily application of DLQ01 high dose cutaneous solution in 30 subjects

Treatment:

Drug: prostaglandin F2a analogue in vehicle solution high dose

DLQ01 low dose

Experimental group

Description:

Twice daily application of DLQ01 low dose cutaneous solution in 30 subjects

Treatment:

Drug: prostaglandin F2a analogue in vehicle solution low dose

active ingredient-free vehicle solution to DLQ01

Placebo Comparator group

Description:

Twice daily application of DLQ01 vehicle cutaneous solution in 30 subjects

Treatment:

Drug: active ingredient-free vehicle solution to DLQ01

Minoxidil Solution 5%

Active Comparator group

Description:

Twice daily application of the comparator cutaneous solution in 30 subjects

Treatment:

Drug: Minoxidil 5% Topical Solution