Treatment of Melasma With Yellow Light Compared to Tranexamic Acid

Photobiomodulation With Yellow Light in the Treatment of Melasma: Clinical Trial, Randomized, Controlled, Double Blind.

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.

Study Overview

• Status: Terminated
• Conditions: Melasma
• Intervention / Treatment: Device: Photobiomodulation group; Other: Group control (Tranexamic acid)

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 Type: Interventional
• Enrollment (Actual): 21
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • São Paulo, Brazil, 01504001
    • Universidade Nove de Julho
  • São Paulo
    • São Caetano Do Sul, São Paulo, Brazil, 09550050
      • Galache Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 35 years to 50 years (Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Photobiomodulation (PBM) with placebo cosmetic treatment.; 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.	Device: Photobiomodulation group; Participants will have their face sanitized with micellar water (a cosmetic product for cleaning and makeup remover), followed by cleaning with soap. Then, the eyes will be protected with gauze, proper glasses and a black towel on top, a headset with relaxation music will also be placed and then the face will receive the treatment with yellow light. After the session the face will receive sunscreen. A placebo cosmetic will be given to the participant to be applied twice a day and daily sunscreen.
Active Comparator: Photobiomodulation (PBM) sham with 5% liposomal tranexamic acid cosmetic product; 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.	Other: Group control (Tranexamic acid); Participants will have their face sanitized with micellar water. Then, the eyes will be protected with gauze, proper glasses and a black towel on top, a headset with relaxation music will also be placed and then the face will receive the treatment with yellow light sham. The person responsible for applying the PBM will simulate the irradiations by positioning the device in the same places described for the PBM group, however, the equipment will be kept off. After the session the face will receive sunscreen. Will be delivered to patients, liposomal tranexamic acid with use 2 x a day home care and daily sunscreen.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
MASI (Melasma Area and Severity Index)	Determines the affected area and the severity of Melasma, through visual analysis of the affected site and attribution of scores	Before treatment (week 0).
MASI (Melasma Area and Severity Index)	Determines the affected area and the severity of Melasma, through visual analysis of the affected site and attribution of scores	Half treatment (Week 6)
MASI (Melasma Area and Severity Index)	Determines the affected area and the severity of Melasma, through visual analysis of the affected site and attribution of scores	After the treatments (week 12).

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Photography	Registry of photographs at white and wood lamp	Before (week 0), at half (week 6) and after treatment (week 12).
The MELASQoL questionnaire, (Melasma Quality of Life Scale)	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.	Before (week 0), at half (week 6) and after treatment (week 12).
Adverse Effects	Registry of any discomfort or unexpected effect of the treatment	At half (week 6) and after treatment (week 12).
Corneomelametry	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)	Before (week 0), at half (week 6) and after treatment (week 12).
Final global diagnosis of the skin.	Clinical subjective measure with the aid of photographic records, in relation to the change by the severity of Melasma of pigmentation after treatment	Before (week 0), at half (week 6) and after treatment (week 12).

Collaborators and Investigators

• Sponsor: University of Nove de Julho
• Investigators: Study Chair: Thais Rodrigues Galache, MSc Fellow, University of Nove de Julho

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2023
• Primary Completion (Actual): October 30, 2023
• Study Completion (Actual): October 30, 2023

Study Registration Dates

• First Submitted: April 8, 2022
• First Submitted That Met QC Criteria: April 12, 2022
• First Posted (Actual): April 14, 2022

Study Record Updates

• Last Update Posted (Actual): October 21, 2024
• Last Update Submitted That Met QC Criteria: October 17, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Keywords: Melasma; Photobiomodulation; Tranexamic Acid; Low Level Laser Therapy (LLLT)
• Additional Relevant MeSH Terms: Skin Diseases; Hyperpigmentation; Pigmentation Disorders; Melanosis; Molecular Mechanisms of Pharmacological Action; Fibrin Modulating Agents; Antifibrinolytic Agents; Hemostatics; Coagulants; Tranexamic Acid
• Other Study ID Numbers: TRG

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices) will be shared. Researchers who provide a methodologically sound proposal will have access. Proposals should be directed to chrispavani@gmail.com To gain access, data requestors will need to sign a data access agreement.
• IPD Sharing Time Frame: Beginning 3 months following article publication
• IPD Sharing Access Criteria: Researchers who provide a methodologically sound proposal.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No