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NCT06355856 Clinical Trial

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

Alopecia Clinical Trial

— CAPELLI  

Official title:
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

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT06355856
Other study ID # ACH-PNT-04(01/22)
Secondary ID
Status Not yet recruiting
Phase Phase 4
First received
Last updated
Start date April 2024
Est. completion date May 2025

Study information
Verified date March 2024
Source Ache Laboratorios Farmaceuticos S.A.
Contact Renata Herrera
Phone (55-11) 97216-3958
Email pesquisa.clinica@ache.com.br
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 196
Est. completion date May 2025
Est. primary completion date May 2025
Accepts healthy volunteers No
Gender Male
Age group 25 Years to 60 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

Drug:
• DNN.22.17.036
Apply twice daily to the affected area and around it.
• 10573048700
Apply twice daily to the affected area and around it.

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Ache Laboratorios Farmaceuticos S.A.

Outcome
Type Measure Description Time frame Safety issue
Primary 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
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