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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05326997
Other study ID # TRG
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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).
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