A Phase 2 interventional study of Minoxidil 5% Topical Solution and PDFE-2304 Topical Solution in Alopecia, Androgenetic, Baldness and Androgenetic Alopecia (AGA), sponsored by PDFE Pharma Innovations FZCO. Active, not recruiting at 1 site in India. Open to male participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2025-06-08.
Sponsored by PDFE Pharma Innovations FZCO · Phase 2, Interventional, and Treatment
This study will evaluate the safety and efficacy of PDFE-2304 compared with Minoxidil 5% in men with androgenic alopecia (AGA).
609 studies on the registry are indexed under Alopecia; 131 are open to participants now.
This study's planned enrollment of 15 is below the median of 45 across 513 interventional studies indexed under Alopecia.
Browse Alopecia studies →This is the only study on the registry with PDFE Pharma Innovations FZCO as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria -
Approximately one mL dose applied onto a pre-specified scalp area twice daily for 16 weeks.
Drug: PDFE-2304 Topical Solution
Approximately one mL dose applied onto a pre-specified scalp area twice daily for 16 weeks.
Drug: Minoxidil 5% Topical Solution
Approximately one mL dose applied onto a pre-specified scalp area twice daily for 16 weeks.
Approximately one mL dose applied onto a pre-specified scalp area twice daily for 16 weeks.
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)
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).
Time frame: Baseline, Week 16 (Day 112)
Change From Baseline in Target Area Hair Darkness (TAHD)
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).
Time frame: Baseline, Week 16 (Day 112)
Percentage of Participants in Each Response Category of the Global Panel Review (GPR) Score
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.
Time frame: Week 16 (Day 112)
Adverse Events
Any undesirable experience associated with the treatment or the comparator in a study participant.
Time frame: Baseline, Week 16 (Day 112)
Plan to share: No — Legal and Regulatory Barriers
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This study is active, not recruiting, as verified in May 2025. You cannot join it, but the record below documents what was studied.
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