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A Safety and Efficacy Study of PDFE-2304 Topical Solution for the Treatment of Androgenic Alopecia. | Clinical Trials | Clareo Health

ACTIVE_NOT_RECRUITINGPHASE2

A Safety and Efficacy Study of PDFE-2304 Topical Solution for the Treatment of Androgenic Alopecia.

A Triple-Blind, Randomized, Efficacy and Tolerability Comparison Study of PDFE-2304 Topical Solution Versus Minoxidil 5% Topical Solution for the Treatment of Androgenic Alopecia (AGA).

NCT07011485•PDFE Pharma Innovations FZCO

View on ClinicalTrials.gov

Summary

This study will evaluate the safety and efficacy of PDFE-2304 compared with Minoxidil 5% in men with androgenic alopecia (AGA).

Eligibility

Age

18 - 60 years

Sex

MALE

Healthy Volunteers

Inclusion Criteria

•Men who have a presentation of androgenetic alopecia (Norwood II - V).
•Age between 18 to 60 years of age (both inclusive).
•Have no abnormal findings during physical examination.
•Able to comply with the study procedures in the opinion of the PI/CI.
•Able to give written consent for participation in the study.

Exclusion Criteria

•Known hypersensitivity or idiosyncratic reaction to the API´s.
•Clinical diagnosis of non-AGA forms of alopecia.
•History of hair transplants.
•Subject having dyed or bleached hair 12 months prior to study start.
•Use of any topical product in the target region in the last 6 months.
•A medical history of receiving chemotherapy/cytotoxic agents.
•Uncontrolled hypertension.
•Any dermatological disorders (eczema, psoriasis, sun damage, skin cancer).
•Hormonal diseases such as thyroid disorders or diabetes.
•Liver and kidney disease.
+4 more criteria

Locations (1)

Koppal Institute of Medical Sciences

Koppal, Karnataka, India

Key Dates

Start Date

May 14, 2025

Primary Completion Date

August 14, 2025

Completion Date

September 17, 2025

Last Updated

June 8, 2025

Enrollment

ESTIMATED participants

Conditions

Alopecia, AndrogeneticBaldnessAndrogenetic Alopecia (AGA)

Interventions

Minoxidil 5% Topical Solution

DRUG

PDFE-2304 Topical Solution

DRUG

Autologous Hair Follicle Secretome for Androgenic Alopecia (Single Site)

NCT07107841

Androgenic AlopeciaAlopecia+1 more

View study

RECRUITINGEARLY_PHASE1

Efficacy of Dihydroartemisinin for Treating Female Androgenetic Alopecia

NCT07012486

Androgenetic Alopecia (AGA)

View study

COMPLETED

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: June 8, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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A Safety and Efficacy Study of PDFE-2304 Topical Solution for the Treatment of Androgenic Alopecia.

Inclusion Criteria

Exclusion Criteria

Autologous Hair Follicle Secretome for Androgenic Alopecia (Single Site)

Efficacy of Dihydroartemisinin for Treating Female Androgenetic Alopecia

Assessing the Safety and Efficacy of a Novel Microneedling and Laser Device for Male Pattern Hair Loss

Efficacy and Safety of OMA102 in the Treatment of Female Pattern Hair Loss

Laser Assisted Delivery of Minoxidil in Androgenetic Alopecia

A Study of TDM-105795 in Male Subjects With Androgenetic Alopecia (AGA)