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

Ache Laboratorios Farmaceuticos

Status and phase: Not yet enrolling; Phase 4

Conditions: Alopecia

Treatments: Drug: 10573048700; Drug: DNN.22.17.036

Study type: Interventional

Funder types: Industry

Identifiers

NCT06355856

ACH-PNT-04(01/22)

Details and patient eligibility

About

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

Enrollment: 196 estimated patients

Sex: Male

Ages: 25 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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196 participants in 2 patient groups

DNN.22.17.036

Experimental group

Description:

Apply 1 ml to the bald area of the scalp, twice a day for 180 days.

Treatment:

Drug: DNN.22.17.036

10573048700

Active Comparator group

Description:

Apply 1 ml to the bald area of the scalp, twice a day for 180 days.

Treatment:

Drug: 10573048700