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

Phase IV, National, Unicentric, Comparative, Double-Blind, Randomized, Non- Inferiority Clinical Trial to Evaluate the Efficacy and Safety of DNN.22.17.036 Compared to 10573048700 in the Treatment of Androgenetic Alopecia

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

Study Overview

• Status: Not yet recruiting
• Conditions: Alopecia
• Intervention / Treatment: Drug: DNN.22.17.036; Drug: 10573048700

• Study Type: Interventional
• Enrollment (Estimated): 196
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Renata Herrera; Phone Number: (55-11) 97216-3958; Email: pesquisa.clinica@ache.com.br

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: DNN.22.17.036; Apply 1 ml to the bald area of the scalp, twice a day for 180 days.	Drug: DNN.22.17.036; Apply twice daily to the affected area and around it.
Active Comparator: 10573048700; Apply 1 ml to the bald area of the scalp, twice a day for 180 days.	Drug: 10573048700; Apply twice daily to the affected area and around it.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Ache Laboratorios Farmaceuticos S.A.

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2024
• Primary Completion (Estimated): May 1, 2025
• Study Completion (Estimated): May 1, 2025

Study Registration Dates

• First Submitted: April 4, 2024
• First Submitted That Met QC Criteria: April 4, 2024
• First Posted (Actual): April 10, 2024

Study Record Updates

• Last Update Posted (Actual): April 10, 2024
• Last Update Submitted That Met QC Criteria: April 4, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Pathological Conditions, Anatomical; Hypotrichosis; Hair Diseases; Alopecia; Alopecia Areata
• Other Study ID Numbers: ACH-PNT-04(01/22)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No