A Safety and Efficacy Study of PDFE-2304 Topical Solution for the Treatment of Androgenic Alopecia.
NCT ID: NCT07011485
Last Updated: 2025-06-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE2
15 participants
INTERVENTIONAL
2025-05-14
2025-09-17
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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PDFE-2304 Topical Solution
Approximately one mL dose applied onto a pre-specified scalp area twice daily for 16 weeks.
PDFE-2304 Topical Solution
Approximately one mL dose applied onto a pre-specified scalp area twice daily for 16 weeks.
Minoxidil 5% Topical Solution
Approximately one mL dose applied onto a pre-specified scalp area twice daily for 16 weeks.
Minoxidil 5% Topical Solution
Approximately one mL dose applied onto a pre-specified scalp area twice daily for 16 weeks.
Interventions
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Minoxidil 5% Topical Solution
Approximately one mL dose applied onto a pre-specified scalp area twice daily for 16 weeks.
PDFE-2304 Topical Solution
Approximately one mL dose applied onto a pre-specified scalp area twice daily for 16 weeks.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
60 Years
MALE
No
Sponsors
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PDFE Pharma Innovations FZCO
INDUSTRY
Responsible Party
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Locations
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Koppal Institute of Medical Sciences
Koppal, Karnataka, India
Countries
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Other Identifiers
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PDFE-CL-24-001
Identifier Type: -
Identifier Source: org_study_id
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