A Safety and Efficacy Study of PDFE-2304 Topical Solution for the Treatment of Androgenic Alopecia. (NEOPILI-2A)

PDFE Pharma Innovations FZCO

Status and phase: Active, not recruiting; Phase 2

Conditions: Baldness; Androgenetic Alopecia (AGA); Alopecia, Androgenetic

Treatments: Drug: PDFE-2304 Topical Solution; Drug: Minoxidil 5% Topical Solution

Study type: Interventional

Funder types: Industry

Identifiers

NCT07011485

PDFE-CL-24-001

Details and patient eligibility

About

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

Enrollment: 15 estimated patients

Sex: Male

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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15 participants in 2 patient groups

PDFE-2304 Topical Solution

Experimental group

Description:

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

Treatment:

Drug: PDFE-2304 Topical Solution

Minoxidil 5% Topical Solution

Active Comparator group

Description:

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

Treatment:

Drug: Minoxidil 5% Topical Solution