Treatment of Melasma With Yellow Light Compared to Tranexamic Acid

Melasma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05326997
• Other study ID #: TRG
• Status: Recruiting
• Phase: N/A
• Start date: May 1, 2023
• Est. completion date: December 30, 2024

Study information

• Verified date: June 2023
• Source: University of Nove de Julho
• Contact: Christiane Pavani, PhD
• Phone: +551133859222
• Email: chrispavani[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 54
• Est. completion date: December 30, 2024
• Est. primary completion date: September 30, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 35 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Melanosis
• Melasma

Intervention

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.

Locations

Country	Name	City	State
Brazil	Galache Clinic	São Caetano Do Sul	São Paulo
Brazil	Universidade Nove de Julho	São Paulo

Sponsors (1)

Lead Sponsor	Collaborator
University of Nove de Julho

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Before treatment (week 0).
Primary	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	Half treatment (Week 6)
Primary	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	After the treatments (week 12).
Secondary	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)	Before (week 0), at half (week 6) and after treatment (week 12).
Secondary	Photography	Registry of photographs at white and wood lamp	Before (week 0), at half (week 6) and after treatment (week 12).
Secondary	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	Before (week 0), at half (week 6) and after treatment (week 12).
Secondary	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.	Before (week 0), at half (week 6) and after treatment (week 12).
Secondary	Adverse Effects	Registry of any discomfort or unexpected effect of the treatment	At half (week 6) and after treatment (week 12).