Last updated: April 4, 2024
Sponsor: Ache Laboratorios Farmaceuticos S.A.
Overall Status: Active - Not Recruiting
Phase
4
Condition
Alopecia
Hair Loss
Treatment
DNN.22.17.036
10573048700
Clinical Study ID
NCT06355856
ACH-PNT-04(01/22)
Ages 25-60 Male
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Ability to understand and consent to participate in this clinical research, expressedby 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
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, hematologicdisorders, thyroid dysfunction, malnutrition, and other dermatologic disorders thatcontribute to hair loss
Study Design
Total Participants: 196
Treatment Group(s): 2
Primary Treatment: DNN.22.17.036
Phase: 4
Study Start date:
April 01, 2024
Estimated Completion Date:
May 31, 2025