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

Launched by DERMALIQ THERAPEUTICS, INC. · Nov 24, 2022

Keywords

ClinConnect Summary

No description provided

Gender

MALE

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.

Trial Officials