PRO-ACT Study Compares Topical Minoxidil 5% with PRCT vs Plain Minoxidil 5% in Androgenetic Alopecia-Combination Shows Superior Efficacy

Androgenetic alopecia (AGA), characterized by progressive hair follicle miniaturization, presents in distinct patterns in men and women, leading to male pattern hair loss (MPHL) and female pattern hair loss (FPHL), and affects 60–70% of the global population. Topical minoxidil remains the mainstay therapy for AGA, promoting hair regrowth by prolonging the anagen (growth) phase of hair follicles. A unique formulation of Minoxidil 5% combined with bioactive peptides such as Procapil, Redensyl, Caffeine, and Transcutol (PRCT) has been introduced to enhance effectiveness by targeting multiple pathways involved in hair growth and follicular health. Procapil boosts scalp microcirculation and counters DHT, Redensyl activates follicle stem cells, Caffeine improves blood flow and prolongs the anagen phase, while Transcutol enhances skin penetration for better efficacy.

To evaluate the potential of combining minoxidil with bioactive peptides for enhanced hair regrowth in AGA, an open-label, prospective, multicenter real-world evidence (RWE) study was conducted to compare the safety and effectiveness of Minoxidil PRCT with plain 5% minoxidil solution.

A total of 400 patients aged (≥18 years) with clinically diagnosed AGA and no recent history of other hair loss treatments were enrolled across 14 centers in India and treated for 4 months with either Minoxidil 5% with PRCT (n=200) or plain Minoxidil 5% (n=200). Primary outcomes, including changes in hair diameter and terminal and vellus hair counts, were assessed using trichoscopy, while secondary outcomes included patient satisfaction, compliance, and adverse events. Evaluations were conducted at baseline, at the first follow-up (2 months), and at the final follow-up (4 months).

The results revealed findings which include:

1.Primary outcomes: Trichoscopic assessments

• Hair diameter: Minoxidil PRCT combination group showed a significant increase in hair diameter (+4.8 μm, p < 0.001) at 4 month follow-up from baseline compared to non-significant change observed in the plain minoxidil group (+2.7 μm, p = 0.115).
• Terminal hair density: From baseline to 4 months, terminal hair density increased by 27.5 hairs/cm² in the Minoxidil PRCT group (p < 0.001) and by 24 hairs/cm² in the plain Minoxidil group (p < 0.001).
• Vellus hair density: From baseline to 4 months, mean increase in vellus hair density was 9.3 hairs/cm² (32.2 ± 9.57 → 41.5 ± 12.49; p < 0.001) in the Minoxidil PRCT group and 8.0 hairs/cm² in the plain Minoxidil group (31.3 ± 10.5 → 39.3 ± 13.6; p < 0.001).

2.Secondary outcomes

• Patient satisfaction and compliance: Patient satisfaction (very satisfied to satisfied) was reported by 95.9% in the Minoxidil PRCT group versus 27.5% with plain Minoxidil. Compliance >80% was achieved in over 95.9% of Minoxidil PRCT patients compared to 52.2% with plain Minoxidil. (Fig.1)
• Drug tolerability: At 4 months, tolerability was rated excellent to good by 91.9% of patients in the Minoxidil PRCT group versus 54% in the plain Minoxidil group. (Fig.1)
• Adverse events: Incidence of adverse events was slightly lower in the Minoxidil PRCT group (4.0%) than in the plain Minoxidil group (7.5%) (p = 0.133).