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

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ClinicalTrials.gov Identifier: NCT05636904
Recruitment Status : Recruiting
First Posted : December 5, 2022
Last Update Posted : December 21, 2022
Sponsor:
Information provided by (Responsible Party):
Dermaliq Therapeutics, Inc.

Study Description
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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.

Condition or disease Intervention/treatment Phase
Androgenetic Alopecia Drug: prostaglandin F2a analogue in vehicle solution high dose Drug: prostaglandin F2a analogue in vehicle solution low dose Drug: active ingredient-free vehicle solution to DLQ01 Drug: Minoxidil 5% Topical Solution Phase 1 Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : December 5, 2022
Estimated Primary Completion Date : January 2024
Estimated Study Completion Date : March 2024

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: DLQ01 high dose
Twice daily application of DLQ01 high dose cutaneous solution in 30 subjects
 Drug: prostaglandin F2a analogue in vehicle solution high dose
Topical treatment for 24 weeks
Other Name: DLQ01 high dose
Experimental: DLQ01 low dose
Twice daily application of DLQ01 low dose cutaneous solution in 30 subjects
 Drug: prostaglandin F2a analogue in vehicle solution low dose
Topical treatment for 24 weeks
Other Name: DLQ01 low dose
Placebo Comparator: active ingredient-free vehicle solution to DLQ01
Twice daily application of DLQ01 vehicle cutaneous solution in 30 subjects
 Drug: active ingredient-free vehicle solution to DLQ01
Topical treatment for 24 weeks
Other Name: DLQ01 vehicle
Active Comparator: Minoxidil Solution 5%
Twice daily application of the comparator cutaneous solution in 30 subjects
 Drug: Minoxidil 5% Topical Solution
Topical treatment for 24 weeks
Other Name: Regaine®


Outcome Measures
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Primary Outcome Measures :
  1. TAHC (total, terminal, and vellus) [ Time Frame: 28 weeks ]
    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

  2. Cumulative hair thickness density (mm/cm2) [ Time Frame: 28 weeks ]
    Change in cumulative hair thickness density using digital image analysis after 4, 12, and 24 weeks of treatment, and at the follow-up visit.

  3. Anagen/telogen ratio [ Time Frame: 28 weeks ]
    Change in anagen/telogen ratios using digital image analysis after 4, 12, and 24 weeks of treatment, and at the follow-up visit.


Secondary Outcome Measures :
  1. Investigator global assessment (IGA) using a 7-point ordinal scale compared to baseline [ Time Frame: 28 weeks ]
    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

  2. Frequency of scores for cutaneous reactions in the treated area through study day 194 [ Time Frame: 28 weeks ]
    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

  3. Frequency of scores for pigmentation changes compared to non-treated area of scalp and hair through study day 194 [ Time Frame: 28 weeks ]
    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

  4. Number of participants with clinically significant abnormal laboratory test results [ Time Frame: 28 weeks ]
    Collection of safety blood at screening, after 24 weeks of treatment, and at follow-up

  5. Number of participants with clinically significant abnormal heart rate [ Time Frame: 28 weeks ]
    Collection of heart rate at screening, baseline, and after 4, 16, and 24 weeks of treatment, and at follow-up

  6. Number of participants with clinically significant abnormal blood pressure [ Time Frame: 28 weeks ]
    Collection of blood pressure at screening, baseline, and after 4, 16, and 24 weeks of treatment, and at follow-up

  7. Number of participants with clinically significant abnormal ECG readings [ Time Frame: 28 weeks ]
    Collection of 12-lead ECG at screening, and after 4, 12, 16, and 24 weeks of treatment, and at follow-up

  8. Plasma concentrations of DLQ01 [ Time Frame: 24 weeks ]
    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


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05636904


Contacts
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Contact: Betsy Hughes-Formella, PhD +49 6221 4353 ext 0 info@dermaliq.com

Locations
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Australia, Victoria
Dr Rodney Sinclair Pty Ltd, Recruiting
East Melbourne, Victoria, Australia, 3002
Contact: Jo Anne Yeo         
Dr Rodney Sinclair Pty Ltd, Recruiting
Pascoe Vale South, Victoria, Australia, 3044
Contact: Jo Anne Yeo         
Sponsors and Collaborators
Dermaliq Therapeutics, Inc.
Investigators
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Study Director: Betsy Hughes-Formella, PhD Dermaliq Therapeutics, Inc.
More Information
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Responsible Party: Dermaliq Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT05636904    
Other Study ID Numbers: DLQ01-001
First Posted: December 5, 2022    Key Record Dates
Last Update Posted: December 21, 2022
Last Verified: December 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Alopecia
Alopecia Areata
Hypotrichosis
Hair Diseases
Skin Diseases
Pathological Conditions, Anatomical
Minoxidil
Pharmaceutical Solutions
Dinoprost
 Dinoprost tromethamine
Antihypertensive Agents
Vasodilator Agents
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Oxytocics