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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT05636904




Registration number
NCT05636904
Ethics application status
Date submitted
16/11/2022
Date registered
5/12/2022
Date last updated
8/04/2024

Titles & IDs
Public title
Safety and Efficacy Study of Topical DLQ01 in the Treatment of Androgenetic Alopecia (AGA) in Men
Scientific 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
Secondary ID [1] 0 0
DLQ01-001
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Androgenetic Alopecia 0 0
Condition category
Condition code
Inflammatory and Immune System 0 0 0 0
Autoimmune diseases
Skin 0 0 0 0
Other skin conditions

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - prostaglandin F2a analogue in vehicle solution high dose
Treatment: Drugs - prostaglandin F2a analogue in vehicle solution low dose
Treatment: Drugs - active ingredient-free vehicle solution to DLQ01
Treatment: Drugs - Minoxidil 5% Topical Solution

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

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

Placebo Comparator: active ingredient-free vehicle solution to DLQ01 - Twice daily application of DLQ01 vehicle cutaneous solution in 30 subjects

Active Comparator: Minoxidil Solution 5% - Twice daily application of the comparator cutaneous solution in 30 subjects


Treatment: Drugs: prostaglandin F2a analogue in vehicle solution high dose
Topical treatment for 24 weeks

Treatment: Drugs: prostaglandin F2a analogue in vehicle solution low dose
Topical treatment for 24 weeks

Treatment: Drugs: active ingredient-free vehicle solution to DLQ01
Topical treatment for 24 weeks

Treatment: Drugs: Minoxidil 5% Topical Solution
Topical treatment for 24 weeks
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
TAHC (total, terminal, and vellus)
Timepoint [1] 0 0
28 weeks
Primary outcome [2] 0 0
Cumulative hair thickness density (mm/cm2)
Timepoint [2] 0 0
28 weeks
Primary outcome [3] 0 0
Anagen/telogen ratio
Timepoint [3] 0 0
28 weeks
Secondary outcome [1] 0 0
Investigator global assessment (IGA) using a 7-point ordinal scale compared to baseline
Timepoint [1] 0 0
28 weeks
Secondary outcome [2] 0 0
Frequency of scores for cutaneous reactions in the treated area through study day 194
Timepoint [2] 0 0
28 weeks
Secondary outcome [3] 0 0
Frequency of scores for pigmentation changes compared to non-treated area of scalp and hair through study day 194
Timepoint [3] 0 0
28 weeks
Secondary outcome [4] 0 0
Number of participants with clinically significant abnormal laboratory test results
Timepoint [4] 0 0
28 weeks
Secondary outcome [5] 0 0
Number of participants with clinically significant abnormal heart rate
Timepoint [5] 0 0
28 weeks
Secondary outcome [6] 0 0
Number of participants with clinically significant abnormal blood pressure
Timepoint [6] 0 0
28 weeks
Secondary outcome [7] 0 0
Number of participants with clinically significant abnormal ECG readings
Timepoint [7] 0 0
28 weeks
Secondary outcome [8] 0 0
Plasma concentrations of DLQ01
Timepoint [8] 0 0
24 weeks

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
60 Years
Sex
Males
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 1/Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
5/12/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
28/03/2024
Sample size
Target
Accrual to date
Final
120
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Dr Rodney Sinclair Pty Ltd, - East Melbourne
Recruitment hospital [2] 0 0
Dr Rodney Sinclair Pty Ltd, - Pascoe Vale South
Recruitment postcode(s) [1] 0 0
3002 - East Melbourne
Recruitment postcode(s) [2] 0 0
3044 - Pascoe Vale South

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Dermaliq Therapeutics, Inc.
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT05636904
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Betsy Hughes-Formella, PhD
Address 0 0
Dermaliq Therapeutics, Inc.
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries