Clinical trial NCT05636904: Safety and Efficacy Study of Topical DLQ01 in the Treatment of Androgenetic Alopecia (AGA) in Men
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Androgenetic Alopecia
Lead sponsor: Dermaliq Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2022-12-05
Enrollment: 120
Sex: MALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: TAHC (total, terminal, and vellus)
timeFrame: 28 weeks
measure: Cumulative hair thickness density (mm/cm2)
timeFrame: 28 weeks
measure: Anagen/telogen ratio
timeFrame: 28 weeks
Secondary outcomes:
measure: Investigator global assessment (IGA) using a 7-point ordinal scale compared to baseline
timeFrame: 28 weeks
measure: Frequency of scores for cutaneous reactions in the treated area through study day 194
timeFrame: 28 weeks
measure: Frequency of scores for pigmentation changes compared to non-treated area of scalp and hair through study day 194
timeFrame: 28 weeks
measure: Number of participants with clinically significant abnormal laboratory test results
timeFrame: 28 weeks
measure: Number of participants with clinically significant abnormal heart rate
timeFrame: 28 weeks
measure: Number of participants with clinically significant abnormal blood pressure
timeFrame: 28 weeks
measure: Number of participants with clinically significant abnormal ECG readings
timeFrame: 28 weeks
measure: Plasma concentrations of DLQ01
timeFrame: 24 weeks
Other outcomes:
Locations:
city: East Melbourne
country: Australia
facility: Dr Rodney Sinclair Pty Ltd,
state: Victoria
city: Pascoe Vale South
country: Australia
facility: Dr Rodney Sinclair Pty Ltd,
state: Victoria
Study officials:
affiliation: Dermaliq Therapeutics, Inc.
name: Betsy Hughes-Formella, PhD
role: STUDY_DIRECTOR
References: