Treatment of Melasma With Yellow Light Compared to Tranexamic Acid

University of Nove de Julho

Status: Terminated

Conditions: Melasma

Treatments: Other: Group control (Tranexamic acid); Device: Photobiomodulation group

Study type: Interventional

Funder types: Other

Identifiers

NCT05326997

TRG

Details and patient eligibility

About

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.

Full 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.

Enrollment: 21 patients

Sex: Female

Ages: 35 to 50 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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21 participants in 2 patient groups

Photobiomodulation (PBM) with placebo cosmetic treatment.

Experimental group

Description:

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.

Treatment:

Device: Photobiomodulation group

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

Active Comparator group

Description:

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.

Treatment:

Other: Group control (Tranexamic acid)