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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
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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
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Secondary ID [1]
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DLQ01-001
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Androgenetic Alopecia
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Condition category
Condition code
Inflammatory and Immune System
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Autoimmune diseases
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Skin
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Other skin conditions
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Intervention/exposure
Study type
Interventional
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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
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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TAHC (total, terminal, and vellus)
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Assessment method [1]
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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
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Timepoint [1]
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28 weeks
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Primary outcome [2]
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Cumulative hair thickness density (mm/cm2)
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Assessment method [2]
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Change in cumulative hair thickness density using digital image analysis after 4, 12, and 24 weeks of treatment, and at the follow-up visit.
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Timepoint [2]
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28 weeks
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Primary outcome [3]
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Anagen/telogen ratio
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Assessment method [3]
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Change in anagen/telogen ratios using digital image analysis after 4, 12, and 24 weeks of treatment, and at the follow-up visit.
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Timepoint [3]
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28 weeks
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Secondary outcome [1]
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Investigator global assessment (IGA) using a 7-point ordinal scale compared to baseline
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Assessment method [1]
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Investigator assessment of the participant´s scalp hair growth compared to baseline using the following 7-point scale: greatly decreased (-3), moderately decreased (-2), slightly decreased (-1), no change (0), slightly increased (1), moderately increased (2), and greatly increased (3) compared to baseline at 4, 12, 16, and 24 weeks of treatment, and at the follow-up visit
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Timepoint [1]
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28 weeks
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Secondary outcome [2]
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Frequency of scores for cutaneous reactions in the treated area through study day 194
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Assessment method [2]
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Investigator assessment of cutaneous reactions such as erythema, oedema, glazing with fissures, vesicles, or papules, by grading with a clinical 5-point scale: no irritation (0), mild (1), moderate (2), severe (3), and very severe (4) at each visit through study day 194
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Timepoint [2]
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28 weeks
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Secondary outcome [3]
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Frequency of scores for pigmentation changes compared to non-treated area of scalp and hair through study day 194
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Assessment method [3]
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Investigator assessment of pigmentation changes compared to non-treated area of scalp and hair by grading with a clinical 4-point scale: no difference (0), slight difference, \<25% (1), moderate difference, \<50 to 75% (2), significantly darker/lighter, \<75 to 100% (3) at each visit through study day 194
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Timepoint [3]
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28 weeks
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Secondary outcome [4]
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Number of participants with clinically significant abnormal laboratory test results
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Assessment method [4]
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Collection of safety blood at screening, after 24 weeks of treatment, and at follow-up
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Timepoint [4]
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28 weeks
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Secondary outcome [5]
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Number of participants with clinically significant abnormal heart rate
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Assessment method [5]
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Collection of heart rate at screening, baseline, and after 4, 16, and 24 weeks of treatment, and at follow-up
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Timepoint [5]
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28 weeks
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Secondary outcome [6]
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Number of participants with clinically significant abnormal blood pressure
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Assessment method [6]
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Collection of blood pressure at screening, baseline, and after 4, 16, and 24 weeks of treatment, and at follow-up
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Timepoint [6]
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28 weeks
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Secondary outcome [7]
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Number of participants with clinically significant abnormal ECG readings
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Assessment method [7]
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Collection of 12-lead ECG at screening, and after 4, 12, 16, and 24 weeks of treatment, and at follow-up
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Timepoint [7]
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28 weeks
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Secondary outcome [8]
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Plasma concentrations of DLQ01
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Assessment method [8]
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Blood samples for evaluation of plasma concentrations of active ingredient and novel excipient will be taken at baseline (predose) and after 4, 12 and 24 weeks of treatment
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Timepoint [8]
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24 weeks
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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.
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Minimum age
18
Years
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Maximum age
60
Years
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Sex
Males
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Can healthy volunteers participate?
No
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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.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 1
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
5/12/2022
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
28/03/2024
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Sample size
Target
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Accrual to date
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Final
120
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Recruitment in Australia
Recruitment state(s)
VIC
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Recruitment hospital [1]
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Dr Rodney Sinclair Pty Ltd, - East Melbourne
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Recruitment hospital [2]
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Dr Rodney Sinclair Pty Ltd, - Pascoe Vale South
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Recruitment postcode(s) [1]
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3002 - East Melbourne
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Recruitment postcode(s) [2]
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3044 - Pascoe Vale South
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Dermaliq Therapeutics, Inc.
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Address
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Country
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Ethics approval
Ethics application status
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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.
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Trial website
https://clinicaltrials.gov/study/NCT05636904
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Betsy Hughes-Formella, PhD
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Address
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Dermaliq Therapeutics, Inc.
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
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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