Clinical trial NCT05326997: Treatment of Melasma With Yellow Light Compared to Tranexamic Acid
Official title: Photobiomodulation With Yellow Light in the Treatment of Melasma: Clinical Trial, Randomized, Controlled, Double Blind.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Melasma
Keywords: Low Level Laser Therapy (LLLT)
Melasma
Photobiomodulation
Tranexamic Acid
Lead sponsor: University of Nove de Julho
Sponsor class: OTHER
First posted: 2022-04-14
Enrollment: 21
Sex: FEMALE
Minimum age (years): 35
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: MASI (Melasma Area and Severity Index)
timeFrame: Before treatment (week 0).
measure: MASI (Melasma Area and Severity Index)
timeFrame: Half treatment (Week 6)
measure: MASI (Melasma Area and Severity Index)
timeFrame: After the treatments (week 12).
Secondary outcomes:
measure: Corneomelametry
timeFrame: Before (week 0), at half (week 6) and after treatment (week 12).
measure: Photography
timeFrame: Before (week 0), at half (week 6) and after treatment (week 12).
measure: Final global diagnosis of the skin.
timeFrame: Before (week 0), at half (week 6) and after treatment (week 12).
measure: The MELASQoL questionnaire, (Melasma Quality of Life Scale)
timeFrame: Before (week 0), at half (week 6) and after treatment (week 12).
measure: Adverse Effects
timeFrame: At half (week 6) and after treatment (week 12).
Other outcomes:
Locations:
city: São Caetano Do Sul
country: Brazil
facility: Galache Clinic
state: São Paulo
city: São Paulo
country: Brazil
facility: Universidade Nove de Julho
Study officials:
affiliation: University of Nove de Julho
name: Thais Rodrigues Galache, MSc Fellow
role: STUDY_CHAIR
References: