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NCT07887399
New Treatment in Melasma
Conditions: Female, With, Facial, Melasma
Sex: Female
Ages: 18 Years – 60 Years
Healthy volunteers: No
Phase: NA
Enrollment: 75
Sponsor: Sohag University
Location: Faculty of Medicine Sohag University Sohag
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 Criteria
Inclusion Criteria:
* Adult females≥18 years
* All types of Melasma of any severity (epidermal, dermal and mixed)
* Fitzpatrick skin types II-V
Exclusion Criteria:
* \- Recent treatment of Melasma (3months before enrollement in the study)
* Pregnancy and lactation
* Scarring or Keloidal tendency
* Active infection
* Medical treatment including: hormonal therapy, anticoagulant, antiplatelet and photosensitizing drugs
* Systemic diseases including: DM, HTN, Malignancy and bleeding disorders
* Other causes of hyperpigmentation
Source: ClinicalTrials.gov (NCT07887399). StuddyBuddy aggregates publicly available trial information.