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

Primary Purpose

Androgenetic Alopecia

Status
Recruiting
Phase
Phase 1
Locations
Australia
Study Type
Interventional
Intervention
prostaglandin F2a analogue in vehicle solution high dose
prostaglandin F2a analogue in vehicle solution low dose
active ingredient-free vehicle solution to DLQ01
Minoxidil 5% Topical Solution
Sponsored by
Dermaliq Therapeutics, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Androgenetic Alopecia

Eligibility Criteria

18 Years - 60 Years (Adult)MaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Dr Rodney Sinclair Pty Ltd,Recruiting
  • Dr Rodney Sinclair Pty Ltd,Recruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Placebo Comparator

Active Comparator

Arm Label

DLQ01 high dose

DLQ01 low dose

active ingredient-free vehicle solution to DLQ01

Minoxidil Solution 5%

Arm Description

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

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

Twice daily application of DLQ01 vehicle cutaneous solution in 30 subjects

Twice daily application of the comparator cutaneous solution in 30 subjects

Outcomes

Primary Outcome Measures

TAHC (total, terminal, and vellus)
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
Cumulative hair thickness density (mm/cm2)
Change in cumulative hair thickness density using digital image analysis after 4, 12, and 24 weeks of treatment, and at the follow-up visit.
Anagen/telogen ratio
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

Investigator global assessment (IGA) using a 7-point ordinal scale compared to baseline
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
Frequency of scores for cutaneous reactions in the treated area through study day 194
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
Frequency of scores for pigmentation changes compared to non-treated area of scalp and hair through study day 194
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
Number of participants with clinically significant abnormal laboratory test results
Collection of safety blood at screening, after 24 weeks of treatment, and at follow-up
Number of participants with clinically significant abnormal heart rate
Collection of heart rate at screening, baseline, and after 4, 16, and 24 weeks of treatment, and at follow-up
Number of participants with clinically significant abnormal blood pressure
Collection of blood pressure at screening, baseline, and after 4, 16, and 24 weeks of treatment, and at follow-up
Number of participants with clinically significant abnormal ECG readings
Collection of 12-lead ECG at screening, and after 4, 12, 16, and 24 weeks of treatment, and at follow-up
Plasma concentrations of DLQ01
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

Full Information

First Posted
November 16, 2022
Last Updated
December 20, 2022
Sponsor
Dermaliq Therapeutics, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT05636904
Brief Title
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

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
December 5, 2022 (Actual)
Primary Completion Date
January 2024 (Anticipated)
Study Completion Date
March 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Dermaliq Therapeutics, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Androgenetic Alopecia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
DLQ01 high dose
Arm Type
Experimental
Arm Description
Twice daily application of DLQ01 high dose cutaneous solution in 30 subjects
Arm Title
DLQ01 low dose
Arm Type
Experimental
Arm Description
Twice daily application of DLQ01 low dose cutaneous solution in 30 subjects
Arm Title
active ingredient-free vehicle solution to DLQ01
Arm Type
Placebo Comparator
Arm Description
Twice daily application of DLQ01 vehicle cutaneous solution in 30 subjects
Arm Title
Minoxidil Solution 5%
Arm Type
Active Comparator
Arm Description
Twice daily application of the comparator cutaneous solution in 30 subjects
Intervention Type
Drug
Intervention Name(s)
prostaglandin F2a analogue in vehicle solution high dose
Other Intervention Name(s)
DLQ01 high dose
Intervention Description
Topical treatment for 24 weeks
Intervention Type
Drug
Intervention Name(s)
prostaglandin F2a analogue in vehicle solution low dose
Other Intervention Name(s)
DLQ01 low dose
Intervention Description
Topical treatment for 24 weeks
Intervention Type
Drug
Intervention Name(s)
active ingredient-free vehicle solution to DLQ01
Other Intervention Name(s)
DLQ01 vehicle
Intervention Description
Topical treatment for 24 weeks
Intervention Type
Drug
Intervention Name(s)
Minoxidil 5% Topical Solution
Other Intervention Name(s)
Regaine®
Intervention Description
Topical treatment for 24 weeks
Primary Outcome Measure Information:
Title
TAHC (total, terminal, and vellus)
Description
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
Time Frame
28 weeks
Title
Cumulative hair thickness density (mm/cm2)
Description
Change in cumulative hair thickness density using digital image analysis after 4, 12, and 24 weeks of treatment, and at the follow-up visit.
Time Frame
28 weeks
Title
Anagen/telogen ratio
Description
Change in anagen/telogen ratios using digital image analysis after 4, 12, and 24 weeks of treatment, and at the follow-up visit.
Time Frame
28 weeks
Secondary Outcome Measure Information:
Title
Investigator global assessment (IGA) using a 7-point ordinal scale compared to baseline
Description
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
Time Frame
28 weeks
Title
Frequency of scores for cutaneous reactions in the treated area through study day 194
Description
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
Time Frame
28 weeks
Title
Frequency of scores for pigmentation changes compared to non-treated area of scalp and hair through study day 194
Description
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
Time Frame
28 weeks
Title
Number of participants with clinically significant abnormal laboratory test results
Description
Collection of safety blood at screening, after 24 weeks of treatment, and at follow-up
Time Frame
28 weeks
Title
Number of participants with clinically significant abnormal heart rate
Description
Collection of heart rate at screening, baseline, and after 4, 16, and 24 weeks of treatment, and at follow-up
Time Frame
28 weeks
Title
Number of participants with clinically significant abnormal blood pressure
Description
Collection of blood pressure at screening, baseline, and after 4, 16, and 24 weeks of treatment, and at follow-up
Time Frame
28 weeks
Title
Number of participants with clinically significant abnormal ECG readings
Description
Collection of 12-lead ECG at screening, and after 4, 12, 16, and 24 weeks of treatment, and at follow-up
Time Frame
28 weeks
Title
Plasma concentrations of DLQ01
Description
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
Time Frame
24 weeks

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Betsy Hughes-Formella, PhD
Phone
+49 6221 4353
Ext
0
Email
info@dermaliq.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Betsy Hughes-Formella, PhD
Organizational Affiliation
Dermaliq Therapeutics, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Dr Rodney Sinclair Pty Ltd,
City
East Melbourne
State/Province
Victoria
ZIP/Postal Code
3002
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jo Anne Yeo
Facility Name
Dr Rodney Sinclair Pty Ltd,
City
Pascoe Vale South
State/Province
Victoria
ZIP/Postal Code
3044
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jo Anne Yeo

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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