NCT05326997

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.

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 21 (actual)
• Sponsor: University of Nove de Julho · Academic / Other
• Sex: Female
• Age: 35 Years – 50 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Melasma

Interventions

Type	Name	Description
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.
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.

Timeline

• Start date: 2023-05-01
• Primary completion: 2023-10-30
• Completion: 2023-10-30
• First posted: 2022-04-14
• Last updated: 2024-10-21

Locations

2 sites across 1 country: Brazil