Treatment of Melasma With Yellow Light Compared to Tranexamic Acid

NCT05326997 | Terminated

• 1 other identifier: TRG
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 2

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.

Conditions

Melasma

Keywords

Low Level Laser Therapy (LLLT); Melasma; Photobiomodulation; Tranexamic Acid

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (5)

• Corneomelametry

  Before (week 0), at half (week 6) and after treatment (week 12).

• Photography

  Before (week 0), at half (week 6) and after treatment (week 12).

• Final global diagnosis of the skin.

  Before (week 0), at half (week 6) and after treatment (week 12).

• The MELASQoL questionnaire, (Melasma Quality of Life Scale)

  Before (week 0), at half (week 6) and after treatment (week 12).

• Adverse Effects

  At half (week 6) and after treatment (week 12).

Study Arms (2)

Photobiomodulation (PBM) with placebo cosmetic treatment.

EXPERIMENTAL

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

Photobiomodulation (PBM) sham with 5% liposomal tranexamic acid cosmetic product

ACTIVE COMPARATOR

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)

Interventions

Photobiomodulation group DEVICE

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.

Photobiomodulation (PBM) with placebo cosmetic treatment.

Group control (Tranexamic acid) OTHER

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.

Photobiomodulation (PBM) sham with 5% liposomal tranexamic acid cosmetic product

Eligibility Criteria

• Age: 35 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Nove de Julho: lead

Study Sites (2)

Galache Clinic

São Caetano do Sul, São Paulo, 09550050, Brazil

Location

Universidade Nove de Julho

São Paulo, 01504001, Brazil

Location

Related Publications (2)

• Galache TR, Galache M, Barros RTB, Bezerra CDDS, Sena MM, Pavani C. Amber LED photobiomodulation versus tranexamic acid for the treatment of melasma: randomized controlled double-blind pilot trial. Lasers Med Sci. 2025 Jul 12;40(1):313. doi: 10.1007/s10103-025-04567-9.

  PMID: 40650752 DERIVED

• Galache TR, Galache M, Sena MM, Pavani C. Amber photobiomodulation versus tranexamic acid for the treatment of melasma: protocol for a double-blind, randomised controlled trial. BMJ Open. 2023 Jul 21;13(7):e073568. doi: 10.1136/bmjopen-2023-073568.

  PMID: 37479524 DERIVED

MeSH Terms

Conditions

Melanosis

Interventions

Control Groups; Tranexamic Acid

Condition Hierarchy (Ancestors)

Hyperpigmentation; Pigmentation Disorders; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods; Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals

Study Officials

• Thais Rodrigues Galache, MSc Fellow

  University of Nove de Julho

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Neither the participants involved in the study, nor the outcomes assessor will be aware of the groups formed, as well as the treatments received.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Model Details: All participants will receive a skin preparation with enzymatic peeling, for homogeneity in the thickness of the stratum corneum among the participants and to reduce the unwanted reflection of photons. One week after the application of the peeling, the pre-treatment evaluation will be carried out and the participants will receive the intervention related to their treatment group, according to the allocation given by randomization. The area to be treated will be sanitized with Rennova® Beauté Micellar Water for makeup/sunscreen removal. Then, a cleaning foam based on 10% urea from Vivence laboratory will be used and also removed with gauze. After randomization, the study population will be divided into two groups (n=28 per group), wich are: (1) Group A - PBM with yellow LED application + placebo cosmetic treatment Home Care 2x per day, (2) Group B - PBM sham + treatment with 5% liposomal tranexamic acid Home Care cosmetic cream 2x per day.

Study Record Dates

• First Submitted: April 8, 2022
• First Posted: April 14, 2022
• Study Start: May 1, 2023
• Primary Completion: October 30, 2023
• Study Completion: October 30, 2023
• Last Updated: October 21, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Beginning 3 months following article publication
• Access Criteria: Researchers who provide a methodologically sound proposal.

Locations

BR (2)