Enhancing dermatology clinical trials: optimizing sites and strategies for success in India
DOI:
https://doi.org/10.18203/2349-3259.ijct20253341Keywords:
Clinical trial site, CROs, Dermatology clinical research, Institutional ethics committee, Regulatory compliance, SponsorsAbstract
India’s diverse patient population, cost-effective ecosystem and high prevalence of dermatological conditions like chronic inflammatory skin diseases, pigmentary disorders, alopecia and infectious diseases, etc. make it a prime destination for global clinical trials. This article is based on author’s experience in dermatology clinical research, web-based information from public domain including clinical trial registries, regulatory guidelines, review of literature, feasibility templates from sponsors and key industry conferences. It is the first of its kind to outline strategic approaches for optimizing dermatology clinical trial in India. This paper recapitulates importance of advanced diagnostic tools, site setup, infrastructure, regulatory compliance, ethical governance and institutional ethics committee (IEC) in enhancing site’s credibility and attracting sponsors. Additionally, it highlights the research gaps in dermatology and provides a roadmap for sponsors, CROs and investigators aiming to conduct ethical, efficient and impactful dermatology trials in India. These insights aim to equip Indian dermatology sites to attract and manage high-quality clinical trials across all phases.
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Vijayananthan A, Nawawi O. The importance of Good Clinical Practice guidelines and its role in clinical trials. Biomed Imag Intervent J. 2008;4(1):5.
Mathur R, Swaminathan S. National ethical guidelines for biomedical & health research involving human participants, 2017: A commentary. Indian J Med Res. 2018;148(3):279-83. DOI: https://doi.org/10.4103/0971-5916.245303
Bunn GP, editor. Good Clinical Practices in Pharmaceuticals. CRC Press. 2024. DOI: https://doi.org/10.1201/9781003407010
Vijayananthan A, Nawawi O. The importance of Good Clinical Practice guidelines and its role in clinical trials. Biomed Imag Interv J. 2008;4(1):5. DOI: https://doi.org/10.2349/biij.4.1.e5
Bangera s and Latha MS. Site selection for clinical research in India. Asian J Pharm Clin Res. 2015;8(1):10-4.
Panda T, Lala PK, Manoharan K, Jinson J, George M. Evaluation of the current status of Ethics Committees in India using the National Accreditation Board for Hospitals and Health-care Providers, Central Drugs Standard Control Organization (CDSCO) and Department of Health Research databases. Perspect Clin Res. 2025;16:75-80. DOI: https://doi.org/10.4103/picr.picr_40_24
Mullen CG, Houlihan JY, Stroo M, Deeter CE, Freel SA, Padget AM, Snyder DC. Leveraging retooled clinical research infrastructure for Clinical Research Management System implementation at a large Academic Medical Center. J Clin Transl Sci. 2023;7(1):127. DOI: https://doi.org/10.1017/cts.2023.550
Gaurav V, Agrawal S, Najeeb A, Ahuja R, Saurabh S, Gupta S. Advancements in Dermatological Imaging Modalities. Indian Dermatol Online J. 2024;15(2):278-92. DOI: https://doi.org/10.4103/idoj.idoj_852_23
Luo N, Zhong X, Su L, Cheng Z, Ma W, Hao P. Artificial intelligence-assisted dermatology diagnosis: From unimodal to multimodal. Comput Biol Med. 2023;165:107413. DOI: https://doi.org/10.1016/j.compbiomed.2023.107413
Fliorent R, Fardman B, Podwojniak A, Javaid K, Tan IJ, Ghani H, Truong TM, Rao B, Heath C. Artificial intelligence in dermatology: advancements and challenges in skin of color. Int J Dermatol. 2024;63(4):455-61. DOI: https://doi.org/10.1111/ijd.17076
Banerjee P, Das K, Goldust M, Wambier CG. Emerging Technologies in Hair and Nail Diagnosis and Treatment. Dermatol Rev. 2024;5(4):251. DOI: https://doi.org/10.1002/der2.251
Chandrashekar BS, Vartak P, Madura C, Shenoy C, Chandar A, Roopa MS, et al. Laser therapies in androgenetic alopecia: Review and clinical experiences. J Cutan Aesthet Surg. 2024;10:73. DOI: https://doi.org/10.25259/JCAS_73_2024
Post NF, Ezekwe N, Narayan VS, Bekkenk MW, Van Geel N, Hamzavi I, et al. The use of lasers in vitiligo, an overview. J Eur Acad Dermatol Venereol. 2022;36(6):779-89. DOI: https://doi.org/10.1111/jdv.18005
Sanyal RD, Fabi SG. Energy-Based Devices for the Treatment of Facial Skin Conditions in Skin of Color. J Clin Aesthet Dermatol. 2024;17(6):22-32.
Lee SW, Goo BL. High-Intensity Focused Ultrasound Enhances Drug Penetration into the Human Skin in the Franz Diffusion Cell. Clin Cosmet Investig Dermatol. 2024;17:1711-21. DOI: https://doi.org/10.2147/CCID.S457145
Lebiedowska A, Hartman-Petrycka M, Stolecka-Warzecha A, Odrzywołek W, Bożek M, Wilczyński S. The Influence of Skin Parameters and Body Composition on the Tolerance of Pain Stimulus Generated During Electrical Muscle Stimulation (EMS) in Women - Pilot Study. Clin Cosmet Investig Dermatol. 2024;17:1227-43. DOI: https://doi.org/10.2147/CCID.S463676
Rorie DA, Flynn RWV, Grieve K, Doney A, Mackenzie I, MacDonald TM, et al. Electronic case report forms and electronic data capture within clinical trials and pharmacoepidemiology. Br J Clin Pharmacol. 2017;83(9):1880-95. DOI: https://doi.org/10.1111/bcp.13285
Kashyap R, Yenokyan G, Joyner R, Gerstenhaber M, Alderfer M, Siegrist E, Moore J, Paller CJ, Aboumatar H, Potter JJ, Watkins S Jr, Niederhuber JE, Ford DE, Dobs A. Clinical Research Network: JHCRN Infrastructure and Lessons Learned. Clin Transl Sci. 2025;18(1):70123. DOI: https://doi.org/10.1111/cts.70123
Anjaneyan G, Kaliyadan F, Pandhi D, Sankar R. Virtual clinical trials-Implications for future dermatology research. Indian J Dermatol Venereol Leprol. 2024;90(5):636-9. DOI: https://doi.org/10.25259/IJDVL_1379_2023
Gulumkar AA, Balamuralidhara V, Gowrav MP. New drugs and clinical trials rules 2019–A regulatory look. Drug Invention Today. 2020;13(4):34.
Ujiie H, Rosmarin D, Schön MP, Ständer S, Boch K, Metz M, Maurer M, et al. Unmet Medical Needs in Chronic, Non-communicable Inflammatory Skin Diseases. Front Med (Lausanne). 2022;9:875492. DOI: https://doi.org/10.3389/fmed.2022.875492
Criado PR, Lorenzini D, Miot HA, Bueno-Filho R, Carneiro FRO, Ianhez M. New small molecules in dermatology: for the autoimmunity, inflammation and beyond. Inflamm Res. 2023;72(6):1257-4. DOI: https://doi.org/10.1007/s00011-023-01744-w
Mar K, Khalid B, Maazi M, Ahmed R, Wang OJE, Khosravi-Hafshejani T. Treatment of Post-Inflammatory Hyperpigmentation in Skin of Colour: A Systematic Review. J Cutan Med Surg. 2024;28(5):473-80. DOI: https://doi.org/10.1177/12034754241265716
Jiryis B, Toledano O, Avitan-Hersh E, Khamaysi Z. Management of Melasma: Laser and Other Therapies-Review Study. J Clin Med. 2024;13(5):1468. DOI: https://doi.org/10.3390/jcm13051468
Chandrashekar BS, Bharadwaj AV, Chandar A. Efficacy and safety of oral tofacitinib in vitiligo and its variants: A retrospective case series. Pigment International. 2025;12(2):92-8. DOI: https://doi.org/10.4103/pigmentinternational_39_24
Garg S, Vashisht KR, Garg D, Oberoi B, Sharma G. Advancements in Laser Therapies for Dermal Hyperpigmentation in Skin of Color: A Comprehensive Literature Review and Experience of Sequential Laser Treatments in a Cohort of 122 Indian Patients. J Clin Med. 2024;13(7):2116. DOI: https://doi.org/10.3390/jcm13072116
Hu S, Laughter MR, Anderson JB, Sadeghpour M. Emerging topical therapies to treat pigmentary disorders: an evidence-based approach. J Dermatol Treat. 2022;33(4):1931-7. DOI: https://doi.org/10.1080/09546634.2021.1940811
Ersan M, Ozer E, Akin O, Tasli PN, Sahin F. Effectiveness of Exosome Treatment in Androgenetic Alopecia: Outcomes of a Prospective Study. Aesthetic Plast Surg. 2024;48(21):4262-71. DOI: https://doi.org/10.1007/s00266-024-04332-3
Pozo-Pérez L, Tornero-Esteban P, López-Bran E. Clinical and preclinical approach in AGA treatment: a review of current and new therapies in the regenerative field. Stem Cell Res Ther. 2024;15(1):260. DOI: https://doi.org/10.1186/s13287-024-03801-5
Devjani S, Ezemma O, Kelley KJ, Stratton E, Senna M. Androgenetic Alopecia: Therapy Update. Drugs. 2023;83(8):701-15. DOI: https://doi.org/10.1007/s40265-023-01880-x
Chandrashekar BS, Lobo OC, Fusco I, Madeddu F, Zingoni T. Effectiveness of 675-nm Wavelength Laser Therapy in the Treatment of Androgenetic Alopecia Among Indian Patients: Clinical Experimental Study. JMIR Dermatol. 2024;7:60858. DOI: https://doi.org/10.2196/60858
Chandrashekar, B. S., Chandu, M., Shenoy, C., Chandar, A., & Roopa, M. S. (2024). SULT1A1 enzyme booster to amplify topical minoxidil response in androgenic alopecia: a single-center prospective study. International J Res Med Sci. 2024;12(11):4142–5. DOI: https://doi.org/10.18203/2320-6012.ijrms20243362
Chandrashekar BS, Nandhini T, Vasanth V, Sriram R, Navale S. Topical minoxidil fortified with finasteride: An account of maintenance of hair density after replacing oral finasteride. Indian Dermatol Online J. 2015;6(1):17-20. DOI: https://doi.org/10.4103/2229-5178.148925
Li Y, Hu X, Dong G, Wang X, Liu T. Acne treatment: research progress and new perspectives. Front Med (Lausanne). 2024;11:1425675. DOI: https://doi.org/10.3389/fmed.2024.1425675
Cruz S, Vecerek N, Elbuluk N. Targeting Inflammation in Acne: Current Treatments and Future Prospects. Am J Clin Dermatol. 2023;24(5):681-94. DOI: https://doi.org/10.1007/s40257-023-00789-1
Vasam M, Korutla S, Bohara RA. Acne vulgaris: A review of the pathophysiology, treatment and recent nanotechnology-based advances. Biochem Biophys Rep. 2023;36:101578. DOI: https://doi.org/10.1016/j.bbrep.2023.101578
De Almeida CV, Antiga E, Lulli M. Oral and Topical Probiotics and Postbiotics in Skincare and Dermatological Therapy: A Concise Reiew. Microorganisms. 2023 ;11(6):1420. DOI: https://doi.org/10.3390/microorganisms11061420
Bratu E, Solomon V. The treatment in basal cell cancer. German International Journal of Modern Science/Deutsche Internationale Zeitschrift für Zeitgenössische Wissenschaft. 2025;5:97.
Wang X, Ma S, Zhu S, Zhu L, Guo W. Advances in Immunotherapy and Targeted Therapy of Malignant Melanoma. Biomedicines. 2025;13(1):225. DOI: https://doi.org/10.3390/biomedicines13010225
Bhat, Ramesha M; Swathi, N. Missed, but Momentous: A Comprehensive Review of Neglected Tropical Skin Diseases in Southern India and their Global Impact. Clin Dermatol Rev. 2012;9(1):9-16. DOI: https://doi.org/10.4103/cdr.cdr_79_24
Goh E, Chavatte JM, Lin RTP, Ng LFP, Rénia L, Oon HH. Vaccines in Dermatology-Present and Future: A Review. Vaccines (Basel). 2025;13(2):125. DOI: https://doi.org/10.3390/vaccines13020125
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