Efficacy/ Safety of DNN.22.17.036 in Male Patients With Pattern Hair Loss

Phase 4

Not yet recruiting

• Conditions: Alopecia
• Interventions: Drug: DNN.22.17.036; Drug: 10573048700

• Registration Number: NCT06355856
• Lead Sponsor: Ache Laboratorios Farmaceuticos S.A.

Brief Summary

Evaluation of the efficacy and safety of DNN.22.17.036 versus 10573048700 in the treatment of male pattern hair loss.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-03
• Study Start: 2024-04
• Study First Submitted: 2024-04-04
• Study First Submitted QC: 2024-04-04
• Last Update Submitted: 2024-04-04
• Study First Posted: 2024-04-10
• Last Update Posted: 2024-04-10
• Primary Completion: 2025-05
• Study Completion: 2025-05

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Male
• Target Recruitment: 196

Inclusion Criteria

• Ability to understand and consent to participate in this clinical research, expressed by signing the Informed Consent Form (ICF)
• Male participants age 25 or older and 60 age or younger
• Participants who have an intact scalp in the area of product analysis
• Participants with androgenetic alopecia (AGA) with AGA Norwood-Hamilton Scale > II
• Participants with at least 20% telogen effluvium of evaluated by Tricholab

Exclusion Criteria

• Participants who have used immunosuppressants in the 3 months prior to signing the ICF
• Participants with other causes of hair loss or scalp dermatoses
• Participants who have received hair loss treatment in the last 6 months
• Participants with uncontrolled medical conditions, kidney and liver disease
• Participants with a history of hair transplantation, malignancy, hematologic disorders, thyroid dysfunction, malnutrition, and other dermatologic disorders that contribute to hair loss

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
DNN.22.17.036	DNN.22.17.036	Apply 1 ml to the bald area of the scalp, twice a day for 180 days.
10573048700	10573048700	Apply 1 ml to the bald area of the scalp, twice a day for 180 days.

Primary Outcome Measures

Name	Time	Method
Percentage variation of hairs in the hair loss phase	180 days	Percentage variation of hairs in the hair loss phase (telogen hairs), by image analysis with the FotoFinder Leviacam®, after 180 days of treatment.