- Visibility 141 Views
- Downloads 101 Downloads
- Permissions
- DOI 10.18231/j.ijced.11470.1745240325
-
CrossMark
- Citation
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 , *
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.
References
- Oiwoh SO, Enitan AO, Adegbosin OT, Akinboro AO, Onayemi EO. Androgenetic Alopecia: A Review. Niger Postgrad Med J. 2024;31(2):85–92.
- Nargis T, Bejai V, Pinto M, Shenoy MM. Early onset androgenetic alopecia in men and associated risk factors: a hospital based study. Int J Res Dermatol. 2017;3(2):267–71.
- Sakhiya J, Sakhiya D, Modi M, Gandhi S, Daruwala F. Prevalence, severity and associated factor of androgenetic alopecia in the dermatology outpatient clinic: A retrospective study. IP Indian J Clin Exp Dermatol. 2019;5(4):280–7.
- Sibbald C, Castelo-Soccio L. Review of global epidemiology data for alopecia areata highlights gaps and a call for action. Br J Dermatol. 2024;191(3):315–6.
- He F, Shen M, Zhao Z, Liu Y, Zhang S, Tang Y, et al. Epidemiology and disease burden of androgenetic alopecia in college freshmen in China: A population-based study. PLoS One. 2022;17(2):e0263912.
- Lee SH, Yang CS. An intelligent hair and scalp analysis system using camera sensors and Norwood-Hamilton model. Int J Innov Comput Inf Control. 2018;14(2):503–18.
- LUDWIG E. Classification of the types of androgenetic alopecia (common baldness) occurring in the female sex. Br J Dermatol. 1977;97(3):247–54.
- Shivakumar S, Kassir M, Rudnicka L, Galadari H, Grabbe S, Goldust M. Hair transplantation surgery versus other modalities of treatment in androgenetic alopecia: a narrative review. Cosmetics. 2021;8(1):25.
- Messenger AG, Rundegren J. Minoxidil: mechanisms of action on hair growth. Br J Dermatol. 2004;150(2):186–94.
- Shen Y, Zhu Y, Zhang L, Sun J, Xie B, Zhang H et al. New Target for Minoxidil in the Treatment of Androgenetic Alopecia. Drug Des Devel Ther. 2023;17:2537–47.
- Pakhomova EE, Smirnova IO. Comparative Evaluation of the Clinical Efficacy of PRP-Therapy, Minoxidil, and Their Combination with Immunohistochemical Study of the Dynamics of Cell Proliferation in the Treatment of Men with Androgenetic Alopecia. Int J Mol Sci. 2020;21(18):6516.
- Karaca N, Akpolat ND. A comparative study between topical 5% minoxidil and topical “Redensyl, Capixyl, and Procapil” combination in men with androgenetic alopecia. J Cosmetol Trichol. 2019. DOI:
- 4172/2471-9323.1000140
- Fu D, Huang J, Li K, Chen Y, He Y, Sun Y et al. Dihydrotestosterone- induced hair regrowth inhibition by activating androgen receptor in C57BL6 mice simulates androgenetic alopecia. Biomed Pharmacother. 2021;137:111247.
- Katoulis AC, Liakou AI, Koumaki D, Vakirlis E, Tsantes AG, Mortaki D et al. A randomized, single‐blinded, vehicle‐controlled study of a topical active blend in the treatment of androgenetic alopecia. Dermatol Ther. 2020;33(4):e13734.
- Pavithra T, Rajashekar T, Kumar SK, Prasanna H. A Comparative Study of Topical Procapil with Platelet-Rich Plasma Therapy Versus Topical Redensyl, Saw Palmetto, and Biotin With Platelet-Rich Plasma Therapy in the Treatment of Androgenetic Alopecia. Cureus. 2023; 15(5):e38696.
- Mas-Chamberlin C, Mondon P, Lamy F, Peschard O, Lintner K, France S. Reduction of hair-loss: matrikines and plant molecules to the rescue. In: Proceedings of the 7th scientific conference of the Asian society of cosmetic chemists (ASCS): toward a new horizon: uniting cosmetic science with oriental wisdom. 2005.
- Völker JM, Koch N, Becker M, Klenk A. Caffeine and its pharmacological benefits in the management of androgenetic alopecia: a review. Skin Pharmacol Physiol. 2020;33(3):93–109.
- Fahim M, Khoso H, Khan J, Bakhtiar R. Combining topical minoxidil with procapil; an assessment of their comparative efficacy in androgenetic alopecia: A randomized control trail. J Pak Assoc Dermatol. 2024;34(2):384–391.
- Bansal M, Manchanda K, Pandey S. Role of caffeine in the management of androgenetic alopecia. Int J Trichology. 2012;4(3):185–6.
- Subedi L, Pandey P, Shim JH, Kim KT, Cho SS, Koo KT, et al. Preparation of topical bimatoprost with enhanced skin infiltration and in vivo hair regrowth efficacy in androgenic alopecia. Drug Deliv. 2022;29(1):328–41.
- Mura S, Manconi M, Valenti D, Sinico C, Vila AO, Fadda AM. Transcutol containing vesicles for topical delivery of minoxidil. J Drug Target. 2011;19(3):189–96.
- Liang X, Chang Y, Wu H, Liu Y, Zhao J, Wang L et al. Efficacy and Safety of 5% Minoxidil Alone, Minoxidil Plus Oral Spironolactone, and Minoxidil Plus Microneedling on Female Pattern Hair Loss: A Prospective, Single-Center, Parallel-Group, Evaluator Blinded, Randomized Trial. Front Med (Lausanne). 2022;9:905140.
How to Cite This Article
Vancouver
Patel K, Yadalla HKK, Srinivasa S, Singh TR, DV V, group PS. 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 [Internet]. IP Indian J Clin Exp Dermatol. 2025 [cited 2025 Oct 02];11(3):394-399. Available from: https://doi.org/10.18231/j.ijced.11470.1745240325
APA
Patel, K., Yadalla, H. K. K., Srinivasa, S., Singh, T. R., DV, V., group, P. S. (2025). 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. IP Indian J Clin Exp Dermatol, 11(3), 394-399. https://doi.org/10.18231/j.ijced.11470.1745240325
MLA
Patel, Khyati, Yadalla, Hari Kishan Kumar, Srinivasa, Seema, Singh, TN Rekha, DV, Varsha, group, PRO-ACT study. "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." IP Indian J Clin Exp Dermatol, vol. 11, no. 3, 2025, pp. 394-399. https://doi.org/10.18231/j.ijced.11470.1745240325
Chicago
Patel, K., Yadalla, H. K. K., Srinivasa, S., Singh, T. R., DV, V., group, P. S.. "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." IP Indian J Clin Exp Dermatol 11, no. 3 (2025): 394-399. https://doi.org/10.18231/j.ijced.11470.1745240325