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.
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
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
21
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.
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.
Galache Clinic
São Caetano do Sul, São Paulo, Brazil
Universidade Nove de Julho
São Paulo, Brazil
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
Time frame: 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
Time frame: 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
Time frame: After the treatments (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)
Time frame: Before (week 0), at half (week 6) and after treatment (week 12).
Photography
Registry of photographs at white and wood lamp
Time frame: 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
Time frame: 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.
Time frame: Before (week 0), at half (week 6) and after treatment (week 12).
Adverse Effects
Registry of any discomfort or unexpected effect of the treatment
Time frame: At half (week 6) and after treatment (week 12).
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