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

NCT07011485 | Active Not Recruiting Phase 2

• 1 other identifier: PDFE-CL-24-001
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Alopecia, Androgenetic; Baldness; Androgenetic Alopecia (AGA)

Keywords

Double Blind; Randomized; Efficacy; Tolerability; Comparison; Treatment

Outcome Measures

Primary Outcomes (1)

• 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).

  Baseline, Week 16 (Day 112)

Secondary Outcomes (6)

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

  Week 16 (Day 112)

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

  Week 16 (Day 112)

• Change From Baseline in Target Area Hair Width (TAHW)

  Baseline, Week 16 (Day 112)

• Change From Baseline in Target Area Hair Darkness (TAHD)

  Baseline, Week 16 (Day 112)

• Percentage of Participants in Each Response Category of the Global Panel Review (GPR) Score

  Week 16 (Day 112)

Study Arms (2)

PDFE-2304 Topical Solution

EXPERIMENTAL

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

Drug: PDFE-2304 Topical Solution

Minoxidil 5% Topical Solution

ACTIVE COMPARATOR

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

Drug: Minoxidil 5% Topical Solution

Interventions

Minoxidil 5% Topical Solution DRUG

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

Minoxidil 5% Topical Solution

PDFE-2304 Topical Solution DRUG

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

PDFE-2304 Topical Solution

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• PDFE Pharma Innovations FZCO: lead

Study Sites (1)

Koppal Institute of Medical Sciences

Koppal, Karnataka, 583231, India

Location

MeSH Terms

Conditions

Alopecia

Interventions

Minoxidil; Solutions

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrimidines; Pharmaceutical Preparations

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Triple (Participant, Investigator, Outcomes Assessor)
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Parallel-group (2:1)

Study Record Dates

• First Submitted: May 14, 2025
• First Posted: June 8, 2025
• Study Start: May 14, 2025
• Primary Completion: August 14, 2025
• Study Completion: September 17, 2025
• Last Updated: June 8, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)