VDPHL01 for Male Pattern Baldness

Recruiting at 43 trial locations

Overseen By Katie Mateja, MBA

Age: 18+

Sex: Male

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2 & 3

Recruiting

Sponsor: Veradermics, Inc.

Must not be taking: Cimetidine, Ketoconazole, Diazoxide, Corticosteroids

Disqualifiers: Uncontrolled blood pressure, Heart, Thyroid, others

Prior Safety Data

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial requires that you stop using certain medications before participating. Specifically, you must not have used systemic cimetidine, ketoconazole, diazoxide, corticosteroids, or beta blockers within 12 weeks prior to screening. Additionally, you should not have used any topical scalp treatments for hair growth within 4 weeks prior to screening.

What data supports the effectiveness of the drug VDPHL01 for male pattern baldness?

The study on dutasteride, a drug similar to VDPHL01, showed that it improved hair growth and appearance in men with male pattern baldness over 52 weeks, suggesting potential effectiveness for VDPHL01 as well. ^{1 2 3 4 5}

Is VDPHL01 safe for treating male pattern baldness?

There is no specific safety data available for VDPHL01, but similar treatments like dutasteride have shown long-term safety with mild side effects such as nasopharyngitis (common cold), erectile dysfunction, and decreased libido in studies for male pattern baldness. ^{1 2 6 7 8}

What makes the drug VDPHL01 unique for treating male pattern baldness?

VDPHL01 may be unique in its approach by potentially targeting the DKK-1 protein, which is involved in hair follicle cell death and is upregulated by dihydrotestosterone (DHT), a key factor in male pattern baldness. This mechanism could differentiate it from other treatments like finasteride, which primarily works by blocking the conversion of testosterone to DHT. ^{3 9 10 11 12}

Research Team

Reid Waldman, M.D.

Principal Investigator

Veradermics, Inc.

Timothy Durso, M.D.

Principal Investigator

Veradermics, Inc.

Eligibility Criteria

This trial is for males with Androgenetic Alopecia (male pattern baldness), which is hair loss due to a strong response of hair follicles to hormones. Participants must meet certain health criteria and be available for 11 study visits over approximately 13 months.

Inclusion Criteria

I am in good health with normal kidney and liver function.

I agree to keep my hair at least 1/4 inch long and not change my hairstyle, length, or color during the study.

I can take the medication as directed and fill out questionnaires in English.

Exclusion Criteria

My blood pressure is not under control.

Subject has a current or recent history of dietary or weight changes

Subject has a history of prescription drug abuse or illicit drug use within 6 months of screening; history of alcohol abuse within 6 months prior to screening

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Participants receive VDPHL01 or placebo for 6 months in a double-blind, placebo-controlled period

6 months

7 visits (in-person)

Treatment Extension

All participants receive active VDPHL01 in an open-label extension phase

6 months

3 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 month

1 visit (in-person)

Treatment Details

Interventions

• VDPHL01 (Anti-androgen)

Trial Overview The trial tests VDPHL01, an oral medication aimed at treating male pattern baldness. It's a double-blind study, meaning neither the researchers nor participants know who gets the real drug or placebo during the first part of the trial.

Participant Groups

Group I: VDPHL01 QD and Placebo QD Experimental Treatment 1 Intervention

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

Group II: VDHPL01 BID Experimental Treatment 1 Intervention

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

Group III: Placebo BID with treatment extension to VDPHL01 BID Placebo Group 1 Intervention

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.

Group IV: Placebo BID with treatment extension to VDPHL01 QD and Placebo QD Placebo Group 1 Intervention

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

Who Is Running the Clinical Trial?

Veradermics, Inc.

Lead Sponsor

Trials

3

Recruited

700+

Findings from Research

Dutasteride 0.5 mg, taken daily for 52 weeks, demonstrated long-term safety and tolerability in 120 Japanese male patients with androgenetic alopecia, with mild adverse events like nasopharyngitis and erectile dysfunction reported in 17% of participants, none leading to withdrawal from the study.

The treatment resulted in significant improvements in hair growth, hair restoration, and overall hair appearance by the end of the study, indicating its efficacy as a potential treatment for male pattern hair loss.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-term safety and efficacy of dutasteride in the treatment of male patients with androgenetic alopecia. Tsunemi, Y., Irisawa, R., Yoshiie, H., et al.[2022]

In a randomized double-blind trial involving 56 patients with hereditary male pattern baldness, topical minoxidil therapy resulted in cosmetically acceptable hair growth in 32% of participants.

The study found that factors such as the initial number of indeterminate hairs, the duration of baldness, and the size of the balding area were significant indicators of hair regrowth, with no serious side effects reported.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Topical minoxidil therapy in hereditary androgenetic alopecia. De Villez, RL.[2019]

The study identified 29 significant SNPs associated with male pattern baldness (MPB) and developed two predictive models based on these SNPs, demonstrating a high sensitivity of 87.1% for predicting baldness in men under 50 years old.

The extended 20-SNP model showed a strong predictive accuracy (AUC=0.761) for men aged 50 and older, indicating its potential use in genetic testing for predicting MPB patterns, which could be valuable in forensic analysis of physical traits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of DNA variants associated with androgenetic alopecia and their potential to predict male pattern baldness. Marcińska, M., Pośpiech, E., Abidi, S., et al.[2022]

In a study of 26 men with male pattern baldness, significant reductions in hair density and meaningful hair density were observed over 24 months, indicating that androgen-dependent alopecia progressively worsens without treatment.

The findings suggest that effective treatments should focus on maintaining existing hair and potentially promoting the growth of shorter non-vellus hairs to improve appearance, rather than trying to generate new hair.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Natural progression of male pattern baldness in young men. Rushton, DH., Ramsay, ID., Norris, MJ., et al.[2019]

In a 32-week study involving 169 men with androgenetic alopecia, setipiprant (2000 mg daily) did not show any significant improvement in scalp hair growth compared to placebo, as measured by target area hair count and self-assessment.

Setipiprant was found to be safe and well tolerated, with mild to moderate treatment-related adverse events occurring in 25.9% of participants, but no serious adverse events were reported related to the treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Setipiprant for Androgenetic Alopecia in Males: Results from a Randomized, Double-Blind, Placebo-Controlled Phase 2a Trial. DuBois, J., Bruce, S., Stewart, D., et al.[2022]

Topical minoxidil has been shown to improve hair growth by normalizing hair follicles and increasing blood flow to the scalp, with noticeable results typically seen after four to six months of twice-daily application.

While generally safe for patients with normal cardiovascular status, common side effects include mild scalp dryness and irritation, and it is important to monitor cardiovascular health during treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Topical minoxidil therapy for hair regrowth. Rumsfield, JA., West, DP., Fiedler-Weiss, VC.[2013]

The RAMACAP helmet-type low-level laser therapy (LLLT) device significantly improved hair density and diameter in patients with androgenetic alopecia after 24 weeks of treatment, outperforming a sham device in a study of 40 participants.

The treatment was generally safe, with only minor side effects like temporary hair shedding and scalp itching reported, indicating that it could be a viable option for both men and women suffering from hair loss.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Low-level laser therapy for the treatment of androgenetic alopecia in Thai men and women: a 24-week, randomized, double-blind, sham device-controlled trial. Suchonwanit, P., Chalermroj, N., Khunkhet, S.[2020]

A prediction model using 25 single-nucleotide polymorphisms (SNPs) from 2725 German and Dutch males can estimate the risk of early-onset male-pattern baldness (MPB) with an accuracy of 74%, which is promising for early intervention strategies.

The model also indicates that genetic factors account for a significant portion of MPB risk, with 55.8% of early-onset MPB genetic liability explained by common autosomal SNPs, suggesting that further research could enhance predictive accuracy with larger sample sizes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prediction of male-pattern baldness from genotypes. Liu, F., Hamer, MA., Heilmann, S., et al.[2018]

Dihydrotestosterone (DHT) increases the production of dickkopf 1 (DKK-1) in scalp dermal papilla cells, which is linked to hair loss, as DKK-1 inhibits the growth of outer root sheath keratinocytes and promotes cell death.

Neutralizing DKK-1 can reverse the growth inhibition caused by DHT, suggesting that targeting DKK-1 may be a potential therapeutic strategy for treating androgenetic alopecia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dihydrotestosterone-inducible dickkopf 1 from balding dermal papilla cells causes apoptosis in follicular keratinocytes. Kwack, MH., Sung, YK., Chung, EJ., et al.[2022]

In a study of 9 male patients with androgenetic alopecia (AGA), finasteride treatment for 4 months led to increased expression of IGF-1 in the dermal papilla cells in 4 patients, which correlated with moderate clinical improvement in 3 of them after 12 months.

Patients who showed decreased IGF-1 expression experienced clinical worsening, suggesting that IGF-1 may play a role in the effectiveness of finasteride for hair regrowth in AGA.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The expression of insulin-like growth factor 1 in follicular dermal papillae correlates with therapeutic efficacy of finasteride in androgenetic alopecia. Tang, L., Bernardo, O., Bolduc, C., et al.[2019]

Male pattern baldness affects up to 50% of adult males, with treatments like minoxidil (Rogaine) gaining popularity over the past decade.

The article reviews the causes of male pattern baldness and discusses current and future treatment options, highlighting the growing interest in addressing this common condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Male pattern baldness. Duplechain, G., White, JA.[2013]

A genome-wide association study involving 1,125 men identified a new genetic locus at chromosome 20p11.22 linked to androgenic alopecia, confirmed in additional cohorts of 1,650 men.

Men carrying risk alleles at both the 20p11.22 locus and the androgen receptor gene (AR) have a significantly higher risk of developing androgenic alopecia, with odds increased by seven times.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Male-pattern baldness susceptibility locus at 20p11. Richards, JB., Yuan, X., Geller, F., et al.[2019]

References

1. England pubmed.ncbi.nlm.nih.gov

Long-term safety and efficacy of dutasteride in the treatment of male patients with androgenetic alopecia. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Topical minoxidil therapy in hereditary androgenetic alopecia. [2019]

3. United States pubmed.ncbi.nlm.nih.gov

Evaluation of DNA variants associated with androgenetic alopecia and their potential to predict male pattern baldness. [2022]

4. England pubmed.ncbi.nlm.nih.gov

Natural progression of male pattern baldness in young men. [2019]

5. New Zealand pubmed.ncbi.nlm.nih.gov

Setipiprant for Androgenetic Alopecia in Males: Results from a Randomized, Double-Blind, Placebo-Controlled Phase 2a Trial. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Topical minoxidil therapy for hair regrowth. [2013]

7. England pubmed.ncbi.nlm.nih.gov

Low-level laser therapy for the treatment of androgenetic alopecia in Thai men and women: a 24-week, randomized, double-blind, sham device-controlled trial. [2020]

8. England pubmed.ncbi.nlm.nih.gov

Prediction of male-pattern baldness from genotypes. [2018]

9. United States pubmed.ncbi.nlm.nih.gov

Dihydrotestosterone-inducible dickkopf 1 from balding dermal papilla cells causes apoptosis in follicular keratinocytes. [2022]

10. United States pubmed.ncbi.nlm.nih.gov

The expression of insulin-like growth factor 1 in follicular dermal papillae correlates with therapeutic efficacy of finasteride in androgenetic alopecia. [2019]

11. United States pubmed.ncbi.nlm.nih.gov

Male pattern baldness. [2013]

12. United States pubmed.ncbi.nlm.nih.gov

Male-pattern baldness susceptibility locus at 20p11. [2019]