VDPHL01 for Male Pattern Baldness

Not currently recruiting at 43 trial locations

Overseen By Katie Mateja, MBA

Age: 18+

Sex: Male

Trial Phase: Phase 2 & 3

Sponsor: Veradermics, Inc.

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

Disqualifiers: Uncontrolled blood pressure, Heart, Thyroid, others

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

Compensation: Varies

Number of Visits: 12

Duration: 6 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This clinical trial tests VDPHL01, a new oral medication, to determine its safety and effectiveness in treating male pattern baldness, a common form of hair loss caused by a hormone reaction. The trial compares different dosing schedules of VDPHL01 against a placebo (a harmless, inactive pill) to evaluate its effects. It is best suited for men with mild to moderate hair loss from male pattern baldness who are willing to maintain their current hairstyle and length throughout the study. Participants will attend regular study visits over approximately 13 months and must be in good general health. As a Phase 2, Phase 3 trial, this study measures the treatment's effectiveness in a smaller group and represents the final step before FDA approval, offering participants a chance to contribute to a potentially groundbreaking solution for hair loss.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that VDPHL01 is being tested for safety and effectiveness in treating male pattern baldness. So far, participants generally tolerate the treatment well. Other studies with VDPHL01 have not reported any serious side effects, suggesting it might be safe for humans. However, as with any trial, researchers continue to monitor for possible side effects. This ongoing study will provide more information about the safety of VDPHL01 for potential participants. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatment?

Unlike the standard treatments for male pattern baldness, which often include topical minoxidil or oral finasteride, VDPHL01 is administered orally and targets hair growth in a novel way. Researchers are excited about VDPHL01 because it is designed to be taken twice daily or once daily, offering flexible dosing options that could potentially improve adherence and convenience. Additionally, VDPHL01 may offer an alternative mechanism of action, which could provide benefits to those who do not respond well to current therapies. This could represent a significant advancement in treating male pattern baldness, especially for individuals seeking new solutions with potentially different side effect profiles.

What evidence suggests that VDPHL01 might be an effective treatment for male pattern baldness?

Research has shown that VDPHL01 could be a promising treatment for male pattern baldness. In this trial, participants may receive VDPHL01 in different dosing regimens, such as twice a day or once a day, with some groups initially receiving a placebo. Studies have found that this pill affects how hair follicles respond to certain hormones, a main cause of hair loss in androgenetic alopecia (AGA). Clinical data suggests that VDPHL01 can reduce hair thinning by altering this response without using hormones. Early findings also indicate it might help hair regrow, offering a non-hormonal option for people with AGA. More research is underway to confirm these effects, but the initial results are promising. ^{1 3 6 7 8}

Who Is on the Research Team?

Reid Waldman, M.D.

Principal Investigator

Veradermics, Inc.

Timothy Durso, M.D.

Principal Investigator

Veradermics, Inc.

Are You a Good Fit for This Trial?

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

Timeline for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

Interventions

• VDPHL01

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.

How Is the Trial Designed?

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

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.

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

Who Is Running the Clinical Trial?

Veradermics, Inc.

Lead Sponsor

Trials

3

Recruited

700+

Published Research Related to This Trial

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]

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]

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 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]

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]

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]

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]

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]

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 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]

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 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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06724614

NCT06724614 | Efficacy and Safety of VDPHL01 in Males ... 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 ...

2. veradermics.com veradermics.com/veradermics-announces-150million-seriesc-financing

Newsroom VDPHL01 is being developed to become the preferred treatment for women and men with pattern hair loss, also known as androgenetic alopecia.

3. clinicaltrials.gov clinicaltrials.gov/study/NCT06972264

Safety and Efficacy of VDPHL01 in Males With AGA 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 ...

4. alviarmani.com alviarmani.com/vdphl01-veradermics-hair-loss-clinical-trial/

Veradermics VDPHL01: The Non-Hormonal Hair Loss ... Veradermics' VDPHL01 is in Phase 2/3 trials for male hair loss. Discover how this non-hormonal oral treatment may change hair restoration forever.

5. trialstoday.org trialstoday.org/trial/NCT06724614

Efficacy and Safety of VDPHL01 in Males With AGA This study will evaluate the safety and efficacy of VDPHL01 in male subjects with Androgenetic Alopecia (AGA). AGA (or male pattern baldness) ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT06527365

NCT06527365 | Safety and Efficacy of VDPHL01 in Males ... This study will evaluate the safety and efficacy of VDPHL01 in male and female subjects with Androgenetic Alopecia (AGA).

7. withpower.com withpower.com/trial/phase-2-and-3-alopecia-10-2024-2f36c

VDPHL01 for Male Pattern Baldness · Info for Participants 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 ...

8. trialx.com trialx.com/clinical-trials/listings/294213/efficacy-and-safety-of-vdphl01-in-males-with-aga/

Efficacy and Safety of VDPHL01 in Males with AGA 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 ...