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

NCT05636904 | Completed Phase 1

• 1 other identifier: DLQ01-001
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 2

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

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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 Outcomes (8)

• Investigator global assessment (IGA) using a 7-point ordinal scale compared to baseline

  28 weeks

• Frequency of scores for cutaneous reactions in the treated area through study day 194

  28 weeks

• Frequency of scores for pigmentation changes compared to non-treated area of scalp and hair through study day 194

  28 weeks

• Number of participants with clinically significant abnormal laboratory test results

  28 weeks

• Number of participants with clinically significant abnormal heart rate

  28 weeks

Study Arms (4)

DLQ01 high dose

EXPERIMENTAL

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

Drug: prostaglandin F2a analogue in vehicle solution high dose

DLQ01 low dose

EXPERIMENTAL

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

Drug: prostaglandin F2a analogue in vehicle solution low dose

active ingredient-free vehicle solution to DLQ01

PLACEBO COMPARATOR

Twice daily application of DLQ01 vehicle cutaneous solution in 30 subjects

Drug: active ingredient-free vehicle solution to DLQ01

Minoxidil Solution 5%

ACTIVE COMPARATOR

Twice daily application of the comparator cutaneous solution in 30 subjects

Drug: Minoxidil 5% Topical Solution

Interventions

prostaglandin F2a analogue in vehicle solution high dose DRUG

Topical treatment for 24 weeks

Also known as: DLQ01 high dose

DLQ01 high dose

prostaglandin F2a analogue in vehicle solution low dose DRUG

Topical treatment for 24 weeks

Also known as: DLQ01 low dose

DLQ01 low dose

active ingredient-free vehicle solution to DLQ01 DRUG

Topical treatment for 24 weeks

Also known as: DLQ01 vehicle

active ingredient-free vehicle solution to DLQ01

Minoxidil 5% Topical Solution DRUG

Topical treatment for 24 weeks

Also known as: Regaine®

Minoxidil Solution 5%

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Dermaliq Therapeutics, Inc.: lead

Study Sites (2)

Dr Rodney Sinclair Pty Ltd,

East Melbourne, Victoria, 3002, Australia

Location

Dr Rodney Sinclair Pty Ltd,

Pascoe Vale South, Victoria, 3044, Australia

Location

MeSH Terms

Conditions

Alopecia

Interventions

Minoxidil; Solutions

Condition Hierarchy (Ancestors)

Hypotrichosis; Hair Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrimidines; Pharmaceutical Preparations

Study Officials

• Betsy Hughes-Formella, PhD

  Dermaliq Therapeutics, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 16, 2022
• First Posted: December 5, 2022
• Study Start: December 5, 2022
• Primary Completion: March 28, 2024
• Study Completion: March 28, 2024
• Last Updated: April 8, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

AU (2)