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

Phase 2Active Not RecruitingNCT07011485

PDFE Pharma Innovations FZCO15 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Alopecia, Androgenetic Baldness Androgenetic Alopecia (AGA)

Interventions

Minoxidil 5% Topical SolutionDRUG

Approximately one mL dose applied onto a pre-specified scalp area twice daily for 16 weeks.

PDFE-2304 Topical SolutionDRUG

Approximately one mL dose applied onto a pre-specified scalp area twice daily for 16 weeks.

Eligibility

Sex: MALEMin age: 18 YearsMax age: 60 Years

Medical Language ↔ Plain English

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. * Smokers. * Drug or alcohol abuse within 12 months. * No written consent. * The receipt of an investigational product or participation in a drug research study within a period of 90 days prior to the first dose of study drug.

Locations (1)

Koppal Institute of Medical Sciences

Koppal, Karnataka, India

Outcomes

Primary Outcomes

Change From Baseline in Target Area Hair Count (TAHC)

TAHC is measured using digital imaging analysis and is reported in terminal hairs/centimeters squared (cm\^2). A positive change from Baseline indicates improvement (increase in the number of terminal hairs) and a negative change from Baseline indicates worsening (decrease in the number of terminal hairs).

Time frame: Baseline, Week 16 (Day 112)

Secondary Outcomes

Percentage of Participants in Each Response Category of the Subject Self-Assessment in Alopecia (SSA) Score

The SSA score measures scalp hair growth. Using a 7-point scale, participants will answer the Question: "Since the start of the study, the amount of my hair has?": Greatly Increased, Moderately Increased, Slightly Increased, Remained the Same, Slightly Decreased, Moderately Decreased or Greatly Decreased. The percentage of participants in each response category will be presented.

Time frame: Week 16 (Day 112)

Percentage of Participants in Each Response Category of the Investigator Global Assessment (IGA) Score

The investigator will compare the participant's scalp hair growth at Week 16 (Day 112) to a photograph of the scalp taken at Baseline and using the 7-point IGA score, the investigator will answer the question: "Since the start of the study, the amount of the subject's hair has?": Greatly Increased, Moderately Increased, Slightly Increased, Remained the Same, Slightly Decreased, Moderately Decreased or Greatly Decreased. The percentage of participants in each response category is presented.

Time frame: Week 16 (Day 112)

Change From Baseline in Target Area Hair Width (TAHW)

Digital imaging analysis will be used to measure TAHW in millimeters/centimeters squared (mm/cm\^2). The diameters of all terminal hairs (individual hairs ≥ 30 microns in width) in the target area will be summed and reported together. A positive change from Baseline indicates improvement (increase in the diameter of terminal hairs) and a negative change from Baseline indicates worsening (decrease in the diameter of terminal hairs).

Data from ClinicalTrials.gov

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