New Treatment in Melasma

Condition(s) studied

Investigational drug(s) / intervention(s)

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.

Study 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.

Eligibility

Primary outcome measure(s)

• Change in Melasma Area and Severity Index (MASI) score from baseline to the end of the treatment period — 4 months after initiation of treatment
  The mean change in MASI score from baseline to the end of the treatment period (4 months) will be compared among the three treatment groups.

Trial sites (1)

More Sohag University trials in Egypt

Other trials for the same condition