Treatment of Melasma With Yellow Light Compared to Tranexamic Acid

Not Applicable

Terminated

• Conditions: Melasma
• Interventions: Other: Group control (Tranexamic acid); Device: Photobiomodulation group

• Registration Number: NCT05326997
• Lead Sponsor: University of Nove de Julho

Brief Summary

Photobiomodulation (PBM) has been suggested as an alternative treatment for Melasma, showed by the in vitro data, inhibition of the tyrosinase enzyme and reduction in the pigment content by autophagy. This treatment compares with tranexamic acid, where it acts on similar pathways of melanogenesis. A total of 54 female participants, phototype scale Fitzpatrick ll - lV will be recruited which will be distributed among two groups: Light + placebo Home Care cosmetic product and Light sham + Home Care cosmetic product with tranexamic acid. The treatments will consist of 90 days, with application of photobiomodulation (PBM) once a week and application of the cosmetic product twice a day.

Detailed Description

This is a controled, randomized, double blind, two arms clinical trial. The main objective of this study is to evaluate the effect of photobiomodulation with amber light in the treatment of Melasma compared to the effect of tranexamic acid. The sample will be divided into 2 groups: Group 1 will receive PBM with amber Light Emitting Diode (LED) (DMC E-Light ABR), 20 J/cm² and placebo topical cosmetic for use in home care; Group 2 will receive PBM sham and topical cosmetic containing 5% liposomal tranexamic acid for use in home care. A total of 54 women with facial Melasma, aged 35 to 50 will be included. The treatments will consist of 12 sessions, once a week for 3 months. The severity of Melasma will be evaluated through the Melasma Area and Severity Index (MASI index), the pigmentation of the epidermis will be evaluated by corneomelametry, photographic records and the quality of life questionnaire (MELASQoL-PB) will also be made.

Study Timeline

• Study First Submitted: 2022-04-08
• Study First Submitted QC: 2022-04-12
• Study First Posted: 2022-04-14
• Study Start: 2023-05-01
• Primary Completion: 2023-10-30
• Study Completion: 2023-10-30
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-17
• Last Update Posted: 2024-10-21

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 21

Inclusion Criteria

• Feminine gender
• Age between 35 to 50 years
• Phototypes l to lV of the Fitzpatrick scale
• Facial melasma
• Healthy participants without clinical skin comorbidities (psoriasis, vitiligo, rosacea and dermatoses)

Exclusion Criteria

• Pre-existing systemic diseases, autoimmune diseases, digestive system disease
• Polycystic ovary
• Isotretinoin drug use (less than 6 months)
• Sequelae of an accident on the face that interferes with the facial treatment
• Undertakes any treatment for topical or oral Melasma at the time of the research or less than 3 months ago
• Uses retinoic acid, vitamin A derivatives, photosensitizing drugs
• Skin pathologies on the face
• Glaucoma, cataract, cancer patients, pregnant women, lactating women
• Uses oral or intrauterine contraceptives (IUD)
• Thyroid disorders
• Use of hormone replacement
• Bacterial, viral and fungal infections
• Tendency to form keloids

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Photobiomodulation (PBM) sham with 5% liposomal tranexamic acid cosmetic product	Group control (Tranexamic acid)	Participants will receive the simulated intervention with PBM using amber light (DMC E-Light ABR) and will also receive a product for topical home use containing 5% liposomal tranexamic acid.
Photobiomodulation (PBM) with placebo cosmetic treatment.	Photobiomodulation group	Participants will receive the intervention with PBM using amber light (DMC E-Light ABR), 20 J/cm² and will also receive a product for daily home topical use containing only the cosmetic base without active.

Primary Outcome Measures

Name	Time	Method
MASI (Melasma Area and Severity Index)	After the treatments (week 12).	Determines the affected area and the severity of Melasma, through visual analysis of the affected site and attribution of scores

Secondary Outcome Measures

Name	Time	Method
Photography	Before (week 0), at half (week 6) and after treatment (week 12).	Registry of photographs at white and wood lamp
Final global diagnosis of the skin.	Before (week 0), at half (week 6) and after treatment (week 12).	Clinical subjective measure with the aid of photographic records, in relation to the change by the severity of Melasma of pigmentation after treatment
The MELASQoL questionnaire, (Melasma Quality of Life Scale)	Before (week 0), at half (week 6) and after treatment (week 12).	Evaluates the impact of Melasma on the quality of life of those affected by the disease and will be applied with the aim of evaluating facial self-image and their degree of satisfaction.
Corneomelametry	Before (week 0), at half (week 6) and after treatment (week 12).	Quantifies the melanin present in the epidermis, specifically in the stratum corneum. A direct sample of the participant's skin will be collected with cyanoacrylate strippings (CSSS)
Adverse Effects	At half (week 6) and after treatment (week 12).	Registry of any discomfort or unexpected effect of the treatment

Trial Locations

Locations (2)

Galache Clinic; 🇧🇷 São Caetano Do Sul, São Paulo, Brazil

Universidade Nove de Julho; 🇧🇷 São Paulo, Brazil