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New Treatment in Melasma
Sponsor: Sohag University
Summary
This randomized controlled trial aims to compare different therapeutic approaches for the treatment of melasma. Participants will be randomly allocated into three treatment groups receiving modified Kligman formula, microneedling-assisted topical tranexamic acid, or nanotechnology-based topical tranexamic acid. The study will compare these treatment approaches over a defined treatment period followed by a follow-up period. The study will provide evidence regarding the comparative efficacy and safety of these therapeutic modalities in patients with melasma.
Official title: Efficacy and Safety of Topical Nanotechnology-based, Versus Microneedling-assisted Tranexamic Acid in Treatment of Melasma: A Randomized Controlled Trial
Key Details
Gender
FEMALE
Age Range
18 Years - 60 Years
Study Type
INTERVENTIONAL
Enrollment
75
Start Date
2026-10-18
Completion Date
2027-06-18
Last Updated
2026-10-21
Healthy Volunteers
No
Interventions
Tranexamic Acid - topical
Group A: will use daily topical TXA 3% +ZnO suspension (Nano-based Technology) on the entire face 2 times per day. Nanotechnology based formulations are able to overcome skin barrier so the drug will be retained in the epidermis to target melanocytes
Microneedling with Topical Tranexamic acid
Group B: will undergo microneedling over the face for a maximum 4 sessions with a 4-week interval between each session followed by topical TXA gel 3% after session and on daily basis over entire face 2 times per day. Microneedling will be done using (Derma Pen Maglev 3,Germany) with a 32-needle head with a needle depth ranging from 0.25 to 1 mm and adjusted according to the thickness and anatomical site of facial skin
Modified Kligman's Formula
Group C: will use modified Kligman formula every night.
Locations (1)
Faculty of Medicine Sohag University
Sohag, Egypt