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Topical Finasteride + Minoxidil vs Minoxidil in Male Androgenetic Alopecia

NCT05990400Phase 3

Key facts

Status: Unknown
Start: May 2023
Primary completion: Oct 2023
Countries: 1
Sponsor: Universitas Indonesia
Modality: Small Molecules

Drugs: DA-4001C
Conditions: androgenetic alopecia (AGA)

Overview

Phase 3, randomised, double-blind trial of DA-4001C in androgenetic alopecia (AGA) (2 arms), sponsored by Universitas Indonesia. Primary endpoints: Hair density at 12 weeks, Hair diameter (mean thickness) at 12 weeks and 1 more. Status: unknown.

Design

2 arms

Study design: RandomizedDouble-blind

Combination Group
Minoxidil 5% + Finasteride 0.1% topical
Minoxidil Group
Minoxidil 5% topical

Who it enrols

Adult males aged 18-59 with androgenetic alopecia (Hamilton-Norwood type III-V) willing to not cut or color hair. Excludes those with scalp infections, recent hair loss treatments (oral/topical/procedural), sexual disorders, or allergies to study drugs.

Endpoints

Primary

Hair density12 weeks
Hair diameter (mean thickness)12 weeks
Side effects12 weeks

Secondary

Velus hair percentage (hair rate vellus)12 weeks
Terminal hair percentage (hair rate terminal)12 weeks
Dermoscopy12 weeks

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