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

D

Dermaliq Therapeutics

Status and phase

Completed
Phase 2
Phase 1

Conditions

Androgenetic Alopecia

Treatments

Drug: active ingredient-free vehicle solution to DLQ01
Drug: prostaglandin F2a analogue in vehicle solution low dose
Drug: prostaglandin F2a analogue in vehicle solution high dose
Drug: Minoxidil 5% Topical Solution

Study type

Interventional

Funder types

Industry

Identifiers

NCT05636904
DLQ01-001

Details and patient eligibility

About

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.

Enrollment

120 patients

Sex

Male

Ages

18 to 60 years old

Volunteers

No 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.

Trial design

120 participants in 4 patient groups, including a placebo group

DLQ01 high dose
Experimental group
Description:
Twice daily application of DLQ01 high dose cutaneous solution in 30 subjects
Treatment:
Drug: prostaglandin F2a analogue in vehicle solution high dose
DLQ01 low dose
Experimental group
Description:
Twice daily application of DLQ01 low dose cutaneous solution in 30 subjects
Treatment:
Drug: prostaglandin F2a analogue in vehicle solution low dose
active ingredient-free vehicle solution to DLQ01
Placebo Comparator group
Description:
Twice daily application of DLQ01 vehicle cutaneous solution in 30 subjects
Treatment:
Drug: active ingredient-free vehicle solution to DLQ01
Minoxidil Solution 5%
Active Comparator group
Description:
Twice daily application of the comparator cutaneous solution in 30 subjects
Treatment:
Drug: Minoxidil 5% Topical Solution

Trial contacts and locations

0

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Central trial contact

Betsy Hughes-Formella, PhD

Data sourced from clinicaltrials.gov

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