Clinical Research Directory

Efficacy and Safety of Triple-Combination Cream Plus Microneedling Along With Tranexamic Acid Versus Platelet-Rich Plasma in the Treatment of Moderate-to-Severe Melasma: A Randomized Comparative Study

Sponsor: Bangladesh Medical University

Summary

Background Melasma is a chronic acquired pigmentary disorder characterized by symmetrical hyperpigmented macules and patches, predominantly affecting the face. It commonly occurs in individuals with darker skin phototypes and may significantly affect quality of life. Triple-combination cream containing hydroquinone, tretinoin, and fluocinolone acetonide is an established treatment; however, response may be incomplete. Microneedling enhances transdermal drug delivery and promotes dermal remodeling. Tranexamic acid (TXA) inhibits melanogenesis, while platelet-rich plasma (PRP) contains growth factors that may promote dermal remodeling and modulate melanogenesis. Objective To compare the efficacy and safety of triple-combination cream plus microneedling with TXA versus platelet-rich plasma in the treatment of moderate-to-severe melasma. Methods This randomized controlled trial will be conducted in the Department of Dermatology and Venereology, Bangladesh Medical University, over 12 months from protocol acceptance. Patients aged 18-60 years with symmetric facial melasma fulfilling the eligibility criteria will be randomly allocated into two equal groups. Group A will receive triple-combination cream containing fluocinolone acetonide 0.01%, hydroquinone 4%, and tretinoin 0.05% on alternate nights for 12 weeks, along with monthly microneedling with TXA for three sessions. Group B will receive the same cream regimen along with monthly microneedling with PRP for three sessions. Efficacy will be assessed using the modified Melasma Area and Severity Index (mMASI) score. Patient satisfaction and adverse events will also be assessed during follow-up. Appropriate statistical methods will be used for comparison between the groups. Ethical approval will be obtained from the Institutional Review Board of Bangladesh Medical University. Results Results will be assessed and presented after completion of the study. Conclusion Conclusion will be drawn after completion of the study. Keywords: Melasma, tranexamic acid, platelet-rich plasma, microneedling, triple-combination cream, mMASI.

Official title: Efficacy and Safety of Triple-Combination Cream Plus Microneedling Along With Tranexamic Acid Versus Platelet-Rich Plasma

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