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

Phase 2

Active, not recruiting

• Conditions: Alopecia, Androgenetic; Baldness; Androgenetic Alopecia (AGA)
• Interventions: Drug: PDFE-2304 Topical Solution; Drug: Minoxidil 5% Topical Solution

• Registration Number: NCT07011485
• Lead Sponsor: PDFE Pharma Innovations FZCO

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-05
• Study Start: 2025-05-14
• Study First Submitted: 2025-05-14
• Study First Submitted QC: 2025-05-30
• Last Update Submitted: 2025-05-30
• Study First Posted: 2025-06-08
• Last Update Posted: 2025-06-08
• Primary Completion: 2025-08-14
• Study Completion: 2025-09-17

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Male
• Target Recruitment: 15

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PDFE-2304 Topical Solution	PDFE-2304 Topical Solution	Approximately one mL dose applied onto a pre-specified scalp area twice daily for 16 weeks.
Minoxidil 5% Topical Solution	Minoxidil 5% Topical Solution	Approximately one mL dose applied onto a pre-specified scalp area twice daily for 16 weeks.

Primary Outcome Measures

Name	Time	Method
Change From Baseline in Target Area Hair Count (TAHC)	Baseline, Week 16 (Day 112)	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).

Secondary Outcome Measures

Name	Time	Method
Percentage of Participants in Each Response Category of the Investigator Global Assessment (IGA) Score	Week 16 (Day 112)	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.
Change From Baseline in Target Area Hair Darkness (TAHD)	Baseline, Week 16 (Day 112)	Digital imaging analysis will be used to measure TAHD. The darkness of all terminal hairs (individual hairs ≥ 30 microns in width) in the target area will be summed and divided by total number of terminal hairs in the same target area and will be reported as intensity units. A positive change from Baseline indicates improvement (increase in the darkness of terminal hairs) and a negative change from Baseline indicates worsening (decrease in the darkness of terminal hairs).
Percentage of Participants in Each Response Category of the Global Panel Review (GPR) Score	Week 16 (Day 112)	At the completion of the study, 3 independent dermatologists using the 7-point GPR score compared photographs of the participant's scalp hair growth at Week 16 (Day 112) to Baseline will answer the question: "Compared with the baseline image, 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 will be presented.
Adverse Events	Baseline, Week 16 (Day 112)	Any undesirable experience associated with the treatment or the comparator in a study participant.
Percentage of Participants in Each Response Category of the Subject Self-Assessment in Alopecia (SSA) Score	Week 16 (Day 112)	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.
Change From Baseline in Target Area Hair Width (TAHW)	Baseline, Week 16 (Day 112)	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).

Trial Locations

Locations (1)

Koppal Institute of Medical Sciences; 🇮🇳 Koppal, Karnataka, India