VDPHL01 for Male Pattern Baldness

Recruiting at 3 trial locations

Overseen By Jenica Lee, MPH

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Veradermics, Inc.

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

Disqualifiers: Uncontrolled blood pressure, Heart conditions, Thyroid conditions, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 12

Duration: 12 months

70 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial requires that you stop using certain medications before joining. Specifically, you must not have used topical scalp treatments for hair growth within 4 weeks, or systemic cimetidine, ketoconazole, diazoxide, corticosteroids, or beta blockers within 12 weeks prior to screening. Other medications that might interfere with the study may also need to be stopped.

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

The research on dutasteride, a component of VDPHL01, shows it can improve hair growth and appearance in men with male pattern baldness over a year, suggesting potential effectiveness for VDPHL01. ^{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 and minoxidil have been studied. Dutasteride showed mild side effects like nasopharyngitis (cold symptoms), erectile dysfunction, and decreased libido, while minoxidil mostly caused mild scalp dryness and irritation. ^{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 driven by dihydrotestosterone (DHT), a key factor in male pattern baldness. This mechanism could differentiate it from existing treatments like finasteride, which primarily works by blocking the conversion of testosterone to DHT. ^{3 9 10 11 12}

What is the purpose of this trial?

This study will evaluate the safety and efficacy of VDPHL01 in male and female subjects with Androgenetic Alopecia (AGA). AGA (or pattern of hair loss) is a genetic disorder caused by an excessive (too much) hair follicle response to androgens (hormone) that causes hair loss. VDPHL01 8.5 mg Tablets for males and VDPHL01 4.5 mg Tablets for females are an investigational oral drug to treat male and female pattern baldness. This multiple center, open-label, 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). Male subjects that meet the study eligibility criteria will be administered VDPHL01 once daily for 12 months. Female subjects that meet the study eligibility criteria will be administered VDPHL01 either once or twice daily for 12 months.

Research Team

Reid Waldman, M.D.

Principal Investigator

Veradermics, Inc.

Timothy Durso, M.D.

Principal Investigator

Veradermics, Inc.

Eligibility Criteria

This trial is for men with Androgenetic Alopecia, commonly known as male pattern baldness. Participants should be genetically predisposed to hair loss due to a high sensitivity of hair follicles to hormones. The study requires regular visits over 6 months.

Inclusion Criteria

I am a man between 18 and 60 years old.

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

I have been diagnosed with mild to moderate age-related hair loss.

Exclusion Criteria

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

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

I was diagnosed with COVID-19 within the last 16 weeks.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Participants receive VDPHL01 tablets daily for 12 months

12 months

10 visits (in-person) at baseline, week 2, month 1, month 2, month 4, month 6, month 8, month 10, month 12, month 13

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 month

1 visit (in-person) at month 13

Treatment Details

Interventions

• VDPHL01

Trial Overview The trial is testing VDPHL01, an investigational oral tablet intended to treat male pattern baldness by being taken twice daily. It's designed to see if the drug is safe and effective in stopping or reversing hair loss in men.

Participant Groups

Group I: VDPHL01 Tablet Experimental Treatment 1 Intervention

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]