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Treatment of Melasma With Yellow Light Compared to Tranexamic Acid

NCT05326997 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 21

Last updated 2024-10-21

No results posted yet for this study

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.

Conditions

  • Melasma

Interventions

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.

Sponsors & Collaborators

  • University of Nove de Julho

    lead OTHER

Principal Investigators

  • Thais Rodrigues Galache, MSc Fellow · University of Nove de Julho

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
35 Years
Max Age
50 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-05-01
Primary Completion
2023-10-30
Completion
2023-10-30

Countries

  • Brazil

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05326997 on ClinicalTrials.gov