Treatment of Melasma With Yellow Light Compared to Tranexamic Acid

NCT ID: NCT05326997

Last Updated: 2024-10-21

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 21 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-05-01
• Study Completion Date: 2023-10-30

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.

Conditions

Melasma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

Photobiomodulation group

Intervention Type: DEVICE

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.

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.

Group Type: ACTIVE_COMPARATOR

Group control (Tranexamic acid)

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: DEVICE

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.

Intervention Type: OTHER

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

• Minimum Eligible Age: 35 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

University of Nove de Julho

OTHER

Sponsor Role: lead

Responsible Party

Christiane Pavani

Clinical Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Thais Rodrigues Galache, MSc Fellow

Role: STUDY_CHAIR

University of Nove de Julho

Locations

Galache Clinic

São Caetano do Sul, São Paulo, Brazil

Universidade Nove de Julho

São Paulo, , Brazil

Countries

Brazil

References

Galache TR, Galache M, Barros RTB, Bezerra CDDS, Sena MM, Pavani C. Amber LED photobiomodulation versus tranexamic acid for the treatment of melasma: randomized controlled double-blind pilot trial. Lasers Med Sci. 2025 Jul 12;40(1):313. doi: 10.1007/s10103-025-04567-9.

Reference Type: DERIVED

PMID: 40650752 (View on PubMed)

Galache TR, Galache M, Sena MM, Pavani C. Amber photobiomodulation versus tranexamic acid for the treatment of melasma: protocol for a double-blind, randomised controlled trial. BMJ Open. 2023 Jul 21;13(7):e073568. doi: 10.1136/bmjopen-2023-073568.

Reference Type: DERIVED

PMID: 37479524 (View on PubMed)

Other Identifiers

TRG

Identifier Type: -

Identifier Source: org_study_id