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

NCT06355856 | Not Yet Recruiting Phase 4

• 1 other identifier: ACH-PNT-04(01/22)
• Study Type: interventional
• Target: 196
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Alopecia

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

DNN.22.17.036

EXPERIMENTAL

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

Drug: DNN.22.17.036

10573048700

ACTIVE COMPARATOR

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

Drug: 10573048700

Interventions

DNN.22.17.036 DRUG

Apply twice daily to the affected area and around it.

DNN.22.17.036

10573048700 DRUG

Apply twice daily to the affected area and around it.

10573048700

Eligibility Criteria

• Age: 25 Years - 60 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ache Laboratorios Farmaceuticos S.A.: lead

MeSH Terms

Conditions

Alopecia

Condition Hierarchy (Ancestors)

Hypotrichosis; Hair Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Renata Herrera

CONTACT

(55-11) 97216-3958; pesquisa.clinica@ache.com.br

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 4, 2024
• First Posted: April 10, 2024
• Study Start: April 1, 2024
• Primary Completion: May 1, 2025
• Study Completion: May 1, 2025
• Last Updated: April 10, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share