Treatment of Melasma With Yellow Light Compared to Tranexamic Acid Depigmented.

Sponsor

University of Nove de Julho (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05326997

Collaborator

(none)

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

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 56 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.

Condition or Disease	Intervention/Treatment	Phase
Melasma	Device: Photobiomodulation group Other: Group control (Tranexamic acid)	N/A

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 56 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 Design

Study Type:

Interventional

Anticipated Enrollment :

56 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

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.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.

Masking:

Double (Participant, Outcomes Assessor)

Masking Description:

Neither the participants involved in the study, nor the outcomes assessor will be aware of the groups formed, as well as the treatments received.

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Aug 1, 2022

Anticipated Primary Completion Date :

Jul 30, 2023

Anticipated Study Completion Date :

Jul 30, 2024

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

35 Years to 50 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Inclusion Criteria:

Feminine gender
Age between 35 to 50 years
Phototypes ll 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