Alopecia
Conditions
Brief summary
Evaluation of the efficacy and safety of DNN.22.17.036 versus 10573048700 in the treatment of male pattern hair loss.
Interventions
DRUGDNN.22.17.036
Apply twice daily to the affected area and around it.
DRUG10573048700
Apply twice daily to the affected area and around it.
Sponsors
Ache Laboratorios Farmaceuticos S.A.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
MALE
Age
25 Years to 60 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Contacts
Primary ContactRenata Herrera
Outcome results
None listed