Efficacy and Safety of VDPHL01 in Males With AGA

Veradermics

Status and phase: Active, not recruiting; Phase 3; Phase 2

Conditions: Male Pattern Baldness; AGA; Androgenetic Alopecia

Treatments: Drug: Placebo; Drug: VDPHL01

Study type: Interventional

Funder types: Industry

Identifiers

NCT06724614

250-13951-302

Details and patient eligibility

About

This study will evaluate the safety and efficacy of VDPHL01 in male subjects with Androgenetic Alopecia (AGA).

AGA (or male pattern baldness) is a genetic disorder caused by an excessive (too much) hair follicle response to androgens (hormone) that causes hair loss. VDPHL01 8.5 mg Tablet is an investigational oral drug to treat male pattern baldness.

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).

The first 7 visits will be part of the placebo-controlled period. The next 3 visits will be part of the treatment extension phase. All subjects will receive active drug in the treatment extension phase.

Enrollment: 480 estimated patients

Sex: Male

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Subject is male aged 18-65 years old;
• Subject has a clinical diagnosis of mild to moderate AGA;
• Subject is in good general health and has normal renal and hepatic function;
• Subject is willing to maintain at least 1/4 inch length hair during the study with the same hairstyle, hair length, and hair color throughout the study; maintain consistent use of general hair care products and regimen through the entire study;
• Subject is willing and able to administer the test article as directed read, understand, and complete required questionnaires in English;
• Subject is willing and able to swallow study drug whole;
• Subject agrees to have a micro dot tattoo placed on their scalp;
• Subject agrees to have this area photographed at study visits as indicated in the protocol.

Exclusion criteria

• Subject has uncontrolled blood pressure or orthostatic hypotension;

• Subject has symptoms or history of certain heart or thyroid conditions;

• Subject has a history of or active hair loss due to conditions/diseases other than AGA;

• Subject has a current or recent history of dietary or weight changes, including use of GLP-1 agonists;

• Subject has been diagnosed with COVID-19 within 16 weeks of screening;

• Subject has had previous radiation of the scalp;

• Use of any of the following treatments within the indicated washout period before screening:

  • Subject has used hormone replacement therapy or hormonal modulators within 6 months prior to screening
  • Subject has used oral treatments for hair growth or that can affect hair growth, including systemic retinoids, within 6 months of screening
  • Subject has used systemic calcium channel blockers or beta blockers within 12 weeks prior to screening
  • Subject has used systemic cimetidine, ketoconazole, diazoxide, or corticosteroids (including intramuscular, intraarticular, and intralesional injections) within 12 weeks prior to screening
  • Subject has had any scalp procedures, including surgical, laser, light or energy treatments, micro-needling, injections, platelet rich plasma within 6 months prior to screening
  • Subject has used any topical scalp treatments for hair growth within 12 weeks prior to screening

• Subject has used any other therapy with any medication either topical or oral that might, in the investigator's opinion, interfere with the study;

• Subject has any other condition that, in the investigator's opinion, interfere with the study

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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480 participants in 4 patient groups, including a placebo group

VDHPL01 BID

Experimental group

Description:

VDPHL01 will be taken orally twice a day, once in the AM and once in the PM.

Treatment:

Drug: VDPHL01

VDPHL01 QD and Placebo QD

Experimental group

Description:

Placebo will be taken orally once a day in the AM or PM. VDPHL01 will be taken orally once a day in the AM or PM.

Treatment:

Drug: VDPHL01

Placebo BID with treatment extension to VDPHL01 BID

Placebo Comparator group

Description:

Placebo will be taken orally twice a day, once in the AM and once in the PM for the first 6 months of the study. After month 6, VDPHL01 will be taken orally twice a day, once in the AM and once in the PM.

Treatment:

Drug: Placebo

Placebo BID with treatment extension to VDPHL01 QD and Placebo QD

Placebo Comparator group

Description:

Placebo will be taken orally twice a day, once in the AM and once in the PM for the first 6 months of the study. After month 6, placebo will be taken orally once a day in the AM or PM. VDPHL01 will be taken orally once a day in the AM or PM.

Treatment:

Drug: Placebo