Androgenetic AlopeciaPhase 1/2NCT05636904
Safety and Efficacy Study of Topical DLQ01 in the Treatment of Androgenetic Alopecia (AGA) in Men
A Phase 1/2 study testing Minoxidil 5% Topical Solution in people with Androgenetic Alopecia, run by Dermaliq Therapeutics, Inc. at 2 sites in Australia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years, men only
- Conditions the study is for
- Androgenetic Alopecia
- What is being tested?
- Minoxidil 5% Topical Solution
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 2 sitesAustralia
- Study dates
- 5 Dec 2022to 28 Mar 2024
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
2 sites in 1 country.
Australia2 sites
Dr Rodney Sinclair Pty Ltd,
East Melbourne, Victoria, 3002
Dr Rodney Sinclair Pty Ltd,
Pascoe Vale South, Victoria, 3044
About this study
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
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.
- Conditions
- Androgenetic Alopecia
- Being tested
- 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
- Medical subject headings
- Alopecia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
prostaglandin F2a analogue in vehicle solution high doseDrug
Also called DLQ01 high dose
Topical treatment for 24 weeks
prostaglandin F2a analogue in vehicle solution low doseDrug
Also called DLQ01 low dose
Topical treatment for 24 weeks
active ingredient-free vehicle solution to DLQ01Drug
Also called DLQ01 vehicle
Topical treatment for 24 weeks
Minoxidil 5% Topical SolutionDrug
Also called Regaine®
Topical treatment for 24 weeks
| Study group | Role | What they receive |
|---|---|---|
| DLQ01 high dose | Experimental | Twice daily application of DLQ01 high dose cutaneous solution in 30 subjects Receives: Drug: prostaglandin F2a analogue in vehicle solution high dose |
| DLQ01 low dose | Experimental | Twice daily application of DLQ01 low dose cutaneous solution in 30 subjects Receives: Drug: prostaglandin F2a analogue in vehicle solution low dose |
| active ingredient-free vehicle solution to DLQ01 | Placebo comparator | Twice daily application of DLQ01 vehicle cutaneous solution in 30 subjects Receives: Drug: active ingredient-free vehicle solution to DLQ01 |
| Minoxidil Solution 5% | Active comparator | Twice daily application of the comparator cutaneous solution in 30 subjects Receives: Drug: Minoxidil 5% Topical Solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 28 weeks
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.
Measured: 28 weeks
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.
Measured: 28 weeks
Secondary outcomes (8)
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
Measured: 28 weeks
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
Measured: 28 weeks
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
Measured: 28 weeks
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
Measured: 28 weeks
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
Measured: 28 weeks
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
Measured: 28 weeks
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
Measured: 28 weeks
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
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2022
- Study start5 Dec 2022
- Primary completion28 Mar 2024
- Study completion28 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Androgenetic AlopeciaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dermaliq Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Betsy Hughes-Formella, PhD, Study director, Dermaliq Therapeutics, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05636904
- Sponsor's protocol ID
- DLQ01-001
- Status last verified
- Apr 2024
- First submitted
- 16 Nov 2022
- Last updated
- 8 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05636904
- Acronym / sponsor ID
- DLQ01-001
- Conditions
- Androgenetic Alopecia
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Dermaliq Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 5 Dec 2022 (actual)
- Primary completion
- 28 Mar 2024 (actual)
- Study completion
- 28 Mar 2024 (actual)
- First posted
- 5 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| DLQ01 high dose | Experimental | Drug: prostaglandin F2a analogue in vehicle solution high doseTwice daily application of DLQ01 high dose cutaneous solution in 30 subjects |
| DLQ01 low dose | Experimental | Drug: prostaglandin F2a analogue in vehicle solution low doseTwice daily application of DLQ01 low dose cutaneous solution in 30 subjects |
| active ingredient-free vehicle solution to DLQ01 | Placebo comparator | Drug: active ingredient-free vehicle solution to DLQ01Twice daily application of DLQ01 vehicle cutaneous solution in 30 subjects |
| Minoxidil Solution 5% | Active comparator | Drug: Minoxidil 5% Topical SolutionTwice daily application of the comparator cutaneous solution in 30 subjects |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| prostaglandin F2a analogue in vehicle solution high doseAlso: DLQ01 high doseTopical treatment for 24 weeks | Drug | DLQ01 high dose |
| prostaglandin F2a analogue in vehicle solution low doseAlso: DLQ01 low doseTopical treatment for 24 weeks | Drug | DLQ01 low dose |
| active ingredient-free vehicle solution to DLQ01Also: DLQ01 vehicleTopical treatment for 24 weeks | Drug | active ingredient-free vehicle solution to DLQ01 |
| Minoxidil 5% Topical SolutionAlso: Regaine®Topical treatment for 24 weeks | Drug | Minoxidil Solution 5% |
Primary outcome
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
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.
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.
8 secondary outcomes
Investigator global assessment (IGA) using a 7-point ordinal scale compared to baseline
Time frame: 28 weeks
Frequency of scores for cutaneous reactions in the treated area through study day 194
Time frame: 28 weeks
Frequency of scores for pigmentation changes compared to non-treated area of scalp and hair through study day 194
Time frame: 28 weeks
Number of participants with clinically significant abnormal laboratory test results
Time frame: 28 weeks
Number of participants with clinically significant abnormal heart rate
Time frame: 28 weeks
Number of participants with clinically significant abnormal blood pressure
Time frame: 28 weeks
Number of participants with clinically significant abnormal ECG readings
Time frame: 28 weeks
Plasma concentrations of DLQ01
Time frame: 24 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2024.
- Individual participant dataSharing planned: No
Related trials for Androgenetic Alopecia
Not yet recruitingPhase 2
Phase 2 Efficacy and Safety of PP405 in Adult Females With Androgenetic Alopecia
Androgenetic Alopecia
Not yet recruitingPhase 3
Phase 3 Study to Evaluate the Efficacy and Safety of Oral Minoxidil (N1087) in Men With Androgenetic Alopecia.
Androgenetic Alopecia, Androgenetic Alopecia (AGA)
Not yet recruiting
Study to Evaluate Xtressé Gummy Supplement in Women With Thinning Hair
Androgenetic Alopecia
Not yet recruitingEarly Phase 1
Evaluating the Efficacy of Platelet-rich Plasma Therapy in the Treatment of Androgenic Alopecia
Androgenic Alopecia
Not yet recruitingPhase 3
Phase 3 Clinical Trial to Evaluate the Efficacy and Safety of N1087 in Participants With Female Pattern Hair Loss (MINORA-WOMEN)
Female Pattern Hair Loss, Female Pattern Hair Loss, Androgenic Alopecia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Betsy Hughes-Formella, PhD study director
Dermaliq Therapeutics, Inc.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Minoxidil 5% Topical Solution in people with Androgenetic Alopecia, run by Dermaliq Therapeutics, Inc. at 2 sites in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
TAHC (total, terminal, and vellus) (time frame: 28 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2024.