A prospective multicentric real-world evidence study to evaluate the safety and effectiveness of topical Minoxidil (5%) in combination with Procapil, Redensyl, Caffeine & Transcutol vs. plain Minoxidil (5%) topical solution in patients with Androgenetic Alopecia: PRO-ACT

• Author Details:   
• Khyati Patel
• Hari Kishan Kumar Yadalla
• Seema Srinivasa
• TN Rekha Singh
• Varsha DV
• PRO-ACT study group , ^*

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Background: Androgenetic alopecia (AGA) is a chronic, progressive condition affecting 60–70% of the global population and is associated with a substantial psychosocial burden. Although topical minoxidil 5% is a well-established treatment, its efficacy may be limited in some individuals.

Aim and objective: To evaluate the safety and effectiveness of a novel formulation of Minoxidil 5% combined with Procapil, Redensyl, caffeine, and Transcutol (Minoxidil PRCT combination) compared to plain Minoxidil 5% in individuals with AGA.

Materials and Methods: In this open-label, prospective, multicenter, real-world study, 400 participants with clinically diagnosed AGA were prescribed either the Minoxidil PRCT combination or plain Minoxidil 5% for 4 months. Primary outcomes included changes in hair diameter, terminal and vellus hair count assessed via trichoscopy. Secondary outcomes were patient satisfaction, compliance, and adverse events.

Results: The 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 also improved significantly in both groups from baseline (+27.5 hairs/cm² in the Minoxidil PRCT group and +24 hairs/cm² in the plain minoxidil group; p < 0.001). Patient satisfaction and compliance were higher in the Minoxidil PRCT group. Fewer adverse events were reported in the Minoxidil PRCT group (4%) versus the plain minoxidil group (9.5%).

Conclusion: Minoxidil PRCT demonstrated superior effectiveness, better tolerability, and greater patient satisfaction than plain Minoxidil 5%, supporting its potential as an improved therapeutic option for AGA.