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A comparative study of melasma treatment using non-ablative fractional diode laser alone and in combination with tranexamic acid (TXA)

A comparative study of Melasma treatment using non-ablative fractional diode laser alone and in combination with Tranexamic acid (TXA)

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20250223064831N1
Enrollment
22
Registered
2025-07-02
Start date
2025-07-01
Completion date
Unknown
Last updated
2025-07-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Melasma.

Interventions

Intervention 1: Patients over 18 years of age with melasma who receive laser and tranexamic acid on one side of the face. Intervention 2: Control group: Patients over 18 years of age with melasma who

Sponsors

Tehran University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: The patient must be over 18 years of age. The patient has Fitzpatrick skin type II-IV with bilateral symmetrical Melasma. The patient has had Melasma for at least 6 months.

Exclusion criteria

Exclusion criteria: The patient is pregnant or breastfeeding. The patient has active herpes lesions and active infection in the area being treated with laser. Patients undergoing treatments such as alpha hydroxy acids, birth control pills, chemical peels, dermabrasion, tanning beds, or sunburn that affect skin pigmentation at the time of the study or within the past three months The patient has a history of hypersensitivity to topical medications, a personal or family history of vitiligo, or a history of laser therapy side effects and keloid formation.

Design outcomes

Primary

MeasureTime frame
The degree of patient satisfaction with the treatment. Timepoint: Before and after treatment. Method of measurement: Patient satisfaction questionnaire that provides patient satisfaction with the treatment outcome on a scale of 1-10.;Melasma treatment. Timepoint: Before and after treatment. Method of measurement: In this scoring system, the entire face is divided into four areas: forehead, right malar, left malar, and chin, representing 30, 30, 30, and 10% of the entire face, respectively. . Melasma severity was determined by three variables: percentage of total area involved, on a scale of 0 (no involvement) to 6 (90-100% involvement); darkness, on a scale of 0 (absent) to 4 (maximum); and homogeneity, hyperpigmentation, on a scale of 0 (minimal) to 4 (maximum). The MASI score on each side of the face will be calculated by a blinded rater at baseline and after the last session 2 weeks later with the equation: MASI = 0.3(DF+HF)AF+0.3(DMR+HMR)AMR+0.3(DML+HML)AML+0.1(DC+HC)AC.

Secondary

MeasureTime frame
. Timepoint: . Method of measurement: .;. Timepoint: . Method of measurement: .

Countries

Iran (Islamic Republic of)

Contacts

Public ContactFatima Alhjjar

Tehran University of Medical Sciences

razihospital@sina.tums.ac.ir+98 21 5563 0553

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026