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

NCT ID: NCT06355856

Last Updated: 2024-04-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE4

Total Enrollment

196 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-04-30

Study Completion Date

2025-05-31

Brief Summary

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

Detailed Description

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Conditions

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Alopecia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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DNN.22.17.036

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

Group Type EXPERIMENTAL

DNN.22.17.036

Intervention Type DRUG

Apply twice daily to the affected area and around it.

10573048700

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

Group Type ACTIVE_COMPARATOR

10573048700

Intervention Type DRUG

Apply twice daily to the affected area and around it.

Interventions

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DNN.22.17.036

Apply twice daily to the affected area and around it.

Intervention Type DRUG

10573048700

Apply twice daily to the affected area and around it.

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

25 Years

Maximum Eligible Age

60 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Ache Laboratorios Farmaceuticos S.A.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Central Contacts

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Renata Herrera

Role: CONTACT

(55-11) 97216-3958

Other Identifiers

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ACH-PNT-04(01/22)

Identifier Type: -

Identifier Source: org_study_id

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