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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT05636904
Ethics application status
Date submitted
16/11/2022
Date registered
5/12/2022

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
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
Trial website
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

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT05636904