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

NCT ID: NCT05636904

Last Updated: 2024-04-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-12-05
• Study Completion Date: 2024-03-28

Brief 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.

Conditions

Androgenetic Alopecia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

DLQ01 high dose

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

Group Type: EXPERIMENTAL

prostaglandin F2a analogue in vehicle solution high dose

Intervention Type: DRUG

Topical treatment for 24 weeks

DLQ01 low dose

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

Group Type: EXPERIMENTAL

prostaglandin F2a analogue in vehicle solution low dose

Intervention Type: DRUG

Topical treatment for 24 weeks

active ingredient-free vehicle solution to DLQ01

Twice daily application of DLQ01 vehicle cutaneous solution in 30 subjects

Group Type: PLACEBO_COMPARATOR

active ingredient-free vehicle solution to DLQ01

Intervention Type: DRUG

Topical treatment for 24 weeks

Minoxidil Solution 5%

Twice daily application of the comparator cutaneous solution in 30 subjects

Group Type: ACTIVE_COMPARATOR

Minoxidil 5% Topical Solution

Intervention Type: DRUG

Topical treatment for 24 weeks

Interventions

prostaglandin F2a analogue in vehicle solution high dose

Topical treatment for 24 weeks

Intervention Type: DRUG

prostaglandin F2a analogue in vehicle solution low dose

Topical treatment for 24 weeks

Intervention Type: DRUG

active ingredient-free vehicle solution to DLQ01

Topical treatment for 24 weeks

Intervention Type: DRUG

Minoxidil 5% Topical Solution

Topical treatment for 24 weeks

Intervention Type: DRUG

Other Intervention Names

DLQ01 high dose; DLQ01 low dose; DLQ01 vehicle; Regaine®

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Dermaliq Therapeutics, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Betsy Hughes-Formella, PhD

Role: STUDY_DIRECTOR

Dermaliq Therapeutics, Inc.

Locations

Dr Rodney Sinclair Pty Ltd,

East Melbourne, Victoria, Australia

Dr Rodney Sinclair Pty Ltd,

Pascoe Vale South, Victoria, Australia

Countries

Australia

Other Identifiers

DLQ01-001

Identifier Type: -

Identifier Source: org_study_id