VDPHL01 for Male Pattern Baldness
Recruiting in Palo Alto (17 mi)
+3 other locations
Age: 18+
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Phase 2
Recruiting
Sponsor: Veradermics, Inc.
No Placebo Group
Prior Safety Data
Trial Summary
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.
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.
45678What 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.
1381012Will 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.
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.
2391011Eligibility 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.
I have been diagnosed with mild to moderate age-related hair loss.
I am in good health with normal kidney and liver function.
Exclusion Criteria
I was diagnosed with COVID-19 within the last 16 weeks.
My blood pressure is not under control.
I have a history of heart or thyroid issues.
I have a history of heart or thyroid disease.
I have received an organ transplant.
I have had radiation treatment on my scalp.
Participant Groups
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.
1Treatment groups
Experimental Treatment
Group I: VDPHL01 TabletExperimental Treatment1 Intervention
Find A Clinic Near You
Research locations nearbySelect from list below to view details:
01San Diego, CA
04New Albany, IN
03Hackensack, NJ
02South Jordan, UT
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Who is running the clinical trial?
Veradermics, Inc.Lead Sponsor
References
Natural progression of male pattern baldness in young men. [2019]Twenty-six men who presented with male pattern baldness (androgen-dependent alopecia), were quantitatively evaluated for scalp hair variables and compared with 13 age-matched controls. Compared to controls, significant mean differences for hair variables were found in the frontal-vertex area, while in the occipital area, a reduction in total hair density (hairs/cm2) was the only significant (P less than 0.05) finding. A large proportion (48.5%) of meaningful hair (non-vellus hair) was less than or equal to 40 mm in length, yet had diameters similar to hairs growing much longer. In controls, these hairs accounted for only 12.2% of the total population. Compared to baseline, mean values from the frontal-vertex area of subjects with androgen-dependent alopecia were significantly lower for total hair density, meaningful hair density (non-vellus hairs/cm2) and percentage of hair in the anagen growth phase, 12 and 24 months later. During this time, total hair density decreased by 6.5% after 12 months and by 11.9% after 24 months. Similarly, meaningful hair density declined at 12 months by 10.8% and by 22.7% after 24 months. No change in any hair variable was detected in controls after 12 or 24 months. Our findings suggest that medications capable of maintaining the existing hair population should be regarded as effective treatments for this condition. Left untreated androgen-dependent alopecia progressively deteriorates. The induction of non-vellus hairs less than or equal to 40 mm in length to grow longer, would substantially improve the aesthetic profile without the need to generate new hair.
Topical minoxidil therapy for hair regrowth. [2013]The pathogenesis of hair loss, the postulated mechanisms of minoxidil action on hair growth, and clinical trials, adverse reactions, experimental formulations, and percutaneous absorption of topical minoxidil preparations are reviewed. Topical minoxidil seems to normalize hair follicles and increase blood flow to the scalp. In clinical trials of various formulations, results have varied. Improved hair growth occurred after four to six months of therapy; twice-daily application seems to be indicated. The most frequently reported adverse reactions are mild scalp dryness and irritation and, rarely, allergic contact dermatitis. Current recommendations are to reserve topical minoxidil for patients with normal cardiovascular status and to routinely monitor blood pressure, heart rate, and electrocardiographic changes. A new drug application is pending with FDA for use of topical minoxidil in androgenetic alopecia (male-pattern baldness), which is genetically determined and apparently stimulated by androgens. For alopecia areata, which involves hair loss on the body or scalp, usually patchy and of sudden onset, no reliable treatment has been found, although minoxidil may be efficacious in some patients. Minoxidil has generated new interest in hair-loss research. The etiology of hair loss must be better understood before more effective treatment regimens can be designed.
Topical minoxidil therapy in hereditary androgenetic alopecia. [2019]A randomized double-blind trial of topical minoxidil therapy was carried out on 56 patients with hereditary male pattern baldness. The subjects selected were required to have a discernible balding patch, a minimum of 2.5 cm in diameter on the vertex of the head where the hairs could be counted and photographed. Minoxidil, 1.0 mL, was applied twice a day to the scalp beginning at the balding vertex and spreading centrifugally around the scalp. Cosmetically acceptable hair growth was achieved in 18 patients (32%). The most notable indicators for regrowth of hair were the number of indeterminate hairs initially present, the duration of baldness, and the size of the balding area. No serious systemic or cutaneous side effects were noted.
Male pattern baldness. [2013]Male pattern baldness is a common affliction affecting up to half the adult male population. Although females can be affected, the manifestations are usually limited to thinning of the hair. Over the past decade there has been increasing interest in treating male pattern baldness sparked by the introduction of minoxidil (Rogaine). This article will review the etiology, current treatments, and future developments.
The expression of insulin-like growth factor 1 in follicular dermal papillae correlates with therapeutic efficacy of finasteride in androgenetic alopecia. [2019]It is generally believed that dihydrotestosterone is one of the pivotal mediators of hair loss in androgenetic alopecia (AGA). Finasteride, which blocks the conversion of testosterone to dihydrotestosterone, has now become an integral part of the current treatment approaches for male AGA. Several lines of evidence support the notion that dermal papilla (DP) cells represent the androgen target within the hair follicle. The specific molecular regulators modulated by androgens within hair follicles in the balding scalp are unknown.
Dihydrotestosterone-inducible dickkopf 1 from balding dermal papilla cells causes apoptosis in follicular keratinocytes. [2022]Recent studies suggest that androgen-driven alteration to the autocrine and paracrine factors produced by scalp dermal papilla (DP) cells may be a key to androgen-potentiated balding. Here, we screened dihydrotestosterone (DHT)-regulated genes in balding DP cells and found that dickkopf 1 (DKK-1) is one of the most upregulated genes. DKK-1 messenger RNA is upregulated in 3-6 hours after 50-100 nM DHT treatment and ELISA showed that DKK-1 is secreted from DP cells in response to DHT. A co-culture system using outer root sheath (ORS) keratinocytes and DP cells showed that DHT inhibits the growth of ORS cells, and neutralizing antibody against DKK-1 significantly reversed the growth inhibition of ORS cells. Analysis of co-cultured ORS cells showed a significant increment of sub-G1 apoptotic cells in response to DHT. Also, recombinant human DKK-1 inhibited the growth of ORS cells and triggered apoptotic cell death. In addition, DHT-induced epithelial cell death in cultured hair follicles was reversed by neutralizing DKK-1 antibody. Moreover, immunoblotting showed that the DKK-1 level is up in the bald scalp compared with the haired scalp of patients with androgenetic alopecia. Altogether, our data strongly suggest that DHT-inducible DKK-1 is involved in DHT-driven balding.
Male-pattern baldness susceptibility locus at 20p11. [2019]We conducted a genome-wide association study for androgenic alopecia in 1,125 men and identified a newly associated locus at chromosome 20p11.22, confirmed in three independent cohorts (n = 1,650; OR = 1.60, P = 1.1 x 10(-14) for rs1160312). The one man in seven who harbors risk alleles at both 20p11.22 and AR (encoding the androgen receptor) has a sevenfold-increased odds of androgenic alopecia (OR = 7.12, P = 3.7 x 10(-15)).
Evaluation of DNA variants associated with androgenetic alopecia and their potential to predict male pattern baldness. [2022]Androgenetic alopecia, known in men as male pattern baldness (MPB), is a very conspicuous condition that is particularly frequent among European men and thus contributes markedly to variation in physical appearance traits amongst Europeans. Recent studies have revealed multiple genes and polymorphisms to be associated with susceptibility to MPB. In this study, 50 candidate SNPs for androgenetic alopecia were analyzed in order to verify their potential to predict MPB. Significant associations were confirmed for 29 SNPs from chromosomes X, 1, 5, 7, 18 and 20. A simple 5-SNP prediction model and an extended 20-SNP model were developed based on a discovery panel of 305 males from various European populations fitting one of two distinct phenotype categories. The first category consisted of men below 50 years of age with significant baldness and the second; men aged 50 years or older lacking baldness. The simple model comprised the five best predictors: rs5919324 near AR, rs1998076 in the 20p11 region, rs929626 in EBF1, rs12565727 in TARDBP and rs756853 in HDAC9. The extended prediction model added 15 SNPs from five genomic regions that improved overall prevalence-adjusted predictive accuracy measured by area under the receiver characteristic operating curve (AUC). Both models were evaluated for predictive accuracy using a test set of 300 males reflecting the general European population. Applying a 65% probability threshold, high prediction sensitivity of 87.1% but low specificity of 42.4% was obtained in men aged
Prediction of male-pattern baldness from genotypes. [2018]The global demand for products that effectively prevent the development of male-pattern baldness (MPB) has drastically increased. However, there is currently no established genetic model for the estimation of MPB risk. We conducted a prediction analysis using single-nucleotide polymorphisms (SNPs) identified from previous GWASs of MPB in a total of 2725 German and Dutch males. A logistic regression model considering the genotypes of 25 SNPs from 12 genomic loci demonstrates that early-onset MPB risk is predictable at an accuracy level of 0.74 when 14 SNPs were included in the model, and measured using the area under the receiver-operating characteristic curves (AUC). Considering age as an additional predictor, the model can predict normal MPB status in middle-aged and elderly individuals at a slightly lower accuracy (AUC 0.69-0.71) when 6-11 SNPs were used. A variance partitioning analysis suggests that 55.8% of early-onset MPB genetic liability can be explained by common autosomal SNPs and 23.3% by X-chromosome SNPs. For normal MPB status in elderly individuals, the proportion of explainable variance is lower (42.4% for autosomal and 9.8% for X-chromosome SNPs). The gap between GWAS findings and the variance partitioning results could be explained by a large body of common DNA variants with small effects that will likely be identified in GWAS of increased sample sizes. Although the accuracy obtained here has not reached a clinically desired level, our model was highly informative for up to 19% of Europeans, thus may assist decision making on early MPB intervention actions and in forensic investigations.
Long-term safety and efficacy of dutasteride in the treatment of male patients with androgenetic alopecia. [2022]Androgenetic alopecia is an androgen-induced pattern of progressive hair loss, which occurs in genetically predisposed people. This study aimed to determine long-term safety, tolerability and efficacy of dutasteride 0.5 mg, an inhibitor of 5-α-reductase, in Japanese male patients with androgenetic alopecia. This was a multicenter, open-label, prospective outpatient study (clinicaltrials.gov NCT01831791, GSK identifier ARI114264) in which patients took dutasteride 0.5 mg p.o. once daily for 52 weeks. Primary end-points included adverse event assessment, incidence of drug-related adverse event and premature discontinuations. Secondary end-points included hair growth, hair restoration and global improvement in hair. A total of 120 patients were enrolled, of whom 110 completed 52 weeks of treatment. Nasopharyngitis, erectile dysfunction and decreased libido were the most frequently reported adverse events and most adverse events were mild. Drug-related adverse events were reported with an incidence of 17%, none of which led to study withdrawal. Hair growth (mean target area hair count at week 52), hair restoration (mean target area hair width at week 52) and global appearance of hair (mean of the median score at week 52) improved from baseline during the study. As a potential future treatment option for male androgenetic alopecia, dutasteride 0.5 mg exhibited long-term safety, tolerability and efficacy within this study population.
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]Low-level laser/light therapy (LLLT) has been increasingly used for promoting hair growth in androgenetic alopecia (AGA). Our institute developed a new home-use LLLT device, RAMACAP, with optimal penetrating energy, aiming to improve therapeutic efficacy and compliance. To evaluate the efficacy and safety of the new helmet-type LLLT device in the treatment of AGA, a 24-week, prospective, randomized, double-blind, sham device-controlled clinical trial was conducted. Forty subjects with AGA (20 men and 20 women) were randomized to treat with a laser helmet (RAMACAP) or a sham helmet in the home-based setting for 24 weeks. Hair density, hair diameter, and adverse events were evaluated at baseline and at weeks 8, 16, and 24. Global photographic assessment for hair regrowth after 24 weeks of treatment was performed by investigators and subjects. Thirty-six subjects (19 in the laser group and 17 in the sham group) completed the study. At week 24, the laser helmet was significantly superior to the sham device for increasing hair density and hair diameter (p = 0.002 and p = 0.009, respectively) and showed a significantly greater improvement in global photographic assessment by investigators and subjects. Reported side effects included temporary hair shedding and scalp pruritus. In conclusion, the novel helmet-type LLLT device appears to be an effective treatment option for AGA in both male and female patients with minimal adverse effects. However, the limitations of this study are small sample size, no long-term follow-up data, and use of inappropriate sham devices, which do not reflect the true negative control. Trial registration: http://clinicaltrials.in.th/index.php?tp=regtrials&menu=trialsearch&smenu=fulltext&task=search&task2=view1&id=2061 , identifier TCTR20160910003.
Setipiprant for Androgenetic Alopecia in Males: Results from a Randomized, Double-Blind, Placebo-Controlled Phase 2a Trial. [2022]To evaluate oral setipiprant versus placebo for scalp hair growth in men with androgenetic alopecia (AGA).