Safety and Efficacy of VDPHL01 in Females With Androgenetic Alopecia (AGA)

Conditions

• AGA
• Androgenetic Alopecia
• Androgenetic Alopecia (AGA)
• Female Androgenetic Alopecia
• Hair Loss

Eligibility Criteria

Sex

FEMALE

Age

18 Years - 65 Years

Healthy Volunteers

Not accepted

Interventions

• VDPHL01 QD — DRUG
  VDPHL01 Extended Release (ER) Tablet
• Placebo — DRUG
  Placebo tablet
• VDPHL01 BID — DRUG
  VDPHL01 Extended Release (ER) Tablet
• Placebo — DRUG
  Placebo tablet

Study Details

This study will evaluate the safety and efficacy of VDPHL01 in female subjects with Androgenetic Alopecia (AGA). AGA is a genetic disorder caused by an excessive (too much) hair follicle response to androgens (hormones) that causes hair loss. VDPHL01 is an investigational oral drug to treat AGA. This multi-center, double blind, study will last about 13 months and includes 11 study visits (screening, baseline (day 1), week 2, month 1, month 2, month 4, month 6, month 8, month 10, month 12, month 13).

Key Dates

Start date

Jul 25, 2025

Status verified

Nov 2025

Primary completion

Jun 30, 2027

Completion

Jan 31, 2028

Study Design

Enrollment

552 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: VDPHL01 BID
  VDPHL01 will be taken orally twice a day (BID), once in the AM and once in the PM for the first 6 months of the study. After month 6, subject will continue VDPHL01 BID for an additional 6 months.
• Experimental: VDPHL01 QD and Placebo QD
  Placebo will be taken orally once a day (QD) in the AM or PM. VDPHL01 will be taken orally once a day (QD) in the AM or PM for the first 6 months of the study. After month 6, subject will continue this same dose regimen for an additional 6 months.
• Placebo Comparator: Placebo BID with treatment extension to VDPHL01 BID
  Placebo will be taken orally twice a day (BID), once in the AM and once in the PM for the first 6 months of the study. After month 6, subject will switch to VDPHL01 BID group, and take VDPHL01 orally twice a day (BID), once in the AM and once in the PM for an additional 6 months.
• Placebo Comparator: Placebo BID with treatment extension to VDPHL01 QD and Placebo QD
  Placebo will be taken orally twice a day (BID), once in the AM and once in the PM for the first 6 months of the study. After month 6, subject will switch to VDPHL01 QD and Placebo QD group, and take placebo orally once a day in the AM or PM; VDPHL01 will be taken orally once a day in the AM or PM for an additional 6 months.

Primary Outcome Measure

Changes in non-vellus Target Area Hair Counts (TAHC) [ Time Frame: Month 6 ]

Central Contacts

• AGA Study Manager
  858-571-1800
  [email protected]

Locations (71)

Find similar trials in Birmingham, AL

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