Androgenetic alopecia (AGA) is the most common form of hair loss, affecting up to 80% of men and 50% of women by age 50. It involves progressive miniaturization of hair follicles, shortening of the growth phase, and a shift toward more resting phase hairs. In men, the key factor is heightened sensitivity to dihydrotestosterone (DHT), while in women, the causes are more complex—ranging from hormonal imbalance to perifollicular inflammation and oxidative stress. Current gold-standard treatments like finasteride and minoxidil offer some benefit but are limited by adverse effects and poor user compliance. A novel formulation—Minoxicapil—combining pyrrolidinyl diaminopyrimidine oxide with botanicals such as oleanolic acid, apigenin, and biotinyl tripeptide-1, alongside oral supplementation, has been proposed to provide a multi-targeted, better-tolerated therapeutic alternative.
Methods
This was a prospective, open-label clinical study conducted over three months on 48 patients diagnosed with AGA. Participants were divided into two groups: one received Minoxicapil topical spray alone (Group A), and the other received both the spray and oral Minoxicapil capsules (Group B). Trichoscopic assessments (hair density, shaft thickness, anagen/telogen ratio, and empty follicles) were performed at baseline and post-treatment using a digital dermatoscope. Statistical analysis involved paired and independent t-tests and Cohen’s d effect size calculations to determine intra- and inter-group efficacy.
Key Findings
• Overall Improvements: Both groups showed statistically significant improvements in hair density, shaft thickness, and anagen/telogen ratios, with reductions in telogen hair, empty follicles, and peripilar signs.
• Combination Therapy Superiority: Group B showed significantly greater gains in total hair count (7.13 ± 15.00 vs. -4.67 ± 22.14 hairs; p = 0.039) and anagen hair count (8.99 ± 9.41 vs. 1.28 ± 11.70 hairs; p = 0.016).
• Effect Sizes: Larger effect sizes were seen in Group B—especially for anagen count (d = 0.96), hair density (d = 0.92), and total hair count (d = 0.48). Between-group differences also favored Group B (e.g., anagen count d = 0.73).
• Sex-Specific Trends: Women showed steadier improvements in hair density and anagen conversion, while men experienced greater gains in shaft thickness and fewer empty follicles—likely reflecting sex-based hormonal influences.
• Tolerability and Satisfaction: The treatment was well tolerated overall, with minimal adverse effects (scalp dryness, itching, mild GI symptoms). No minoxidil-like adverse events were reported. Satisfaction scores averaged 1.97/3, indicating a generally positive user experience.
This study highlights the potential of Minoxicapil as a safe, multi-targeted therapy for androgenetic alopecia in both sexes. The combination of topical and oral components significantly improved key hair growth parameters with good tolerability. The unique blend of pyrrolidinyl diaminopyrimidine oxide, oleanolic acid, apigenin, and biotinyl tripeptide-1 acts synergistically to address the hormonal, inflammatory, and vascular pathways of AGA. These findings also provide the first evidence of efficacy for this complex in female pattern hair loss. However, to establish its clinical utility, future randomized, placebo-controlled trials with longer follow-up periods are essential to assess long-term safety and efficacy and determine Minoxicapil’s role in personalized alopecia treatment strategies.
Link to the study: https://tinyurl.com/4pwddj46
