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NCT Number: NCT07011485

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

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

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Alopecia, Androgenetic Alopecia Androgenetic Alopecia (AGA) Baldness Hair Diseases Hypotrichosis Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year–60 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 2

Primary location

Koppal Institute of Medical Sciences

Koppal, Karnataka, 583231, India

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Minoxidil 5% Topical Solution

Drug

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

PDFE-2304 Topical Solution

Drug

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

Primary outcomes

  1. Change From Baseline in Target Area Hair Count (TAHC)

    Time frame: 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 outcomes

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

    Time frame: 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.

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

    Time frame: 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.

  3. Change From Baseline in Target Area Hair Width (TAHW)

    Time frame: 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).

  4. Change From Baseline in Target Area Hair Darkness (TAHD)

    Time frame: 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).

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

    Time frame: 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.

  6. Adverse Events

    Time frame: Baseline, Week 16 (Day 112)

    Any undesirable experience associated with the treatment or the comparator in a study participant.

Sponsors and collaborators

Lead sponsor

PDFE Pharma Innovations FZCO

Industry

Registry information

Official study title

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).

Acronym: NEOPILI-2A

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jun 8, 2025
Registry last updated
Jun 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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