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Treatment of Melasma With Yellow Light Compared to Tranexamic Acid

Primary Purpose

Melasma

Status
Recruiting
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Photobiomodulation group
Group control (Tranexamic acid)
Sponsored by
University of Nove de Julho
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Melasma focused on measuring Low Level Laser Therapy (LLLT), Melasma, Photobiomodulation, Tranexamic Acid

Eligibility Criteria

35 Years - 50 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Feminine gender
  • Age between 35 to 50 years
  • Phototypes ll 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

Sites / Locations

  • Galache ClinicRecruiting
  • Universidade Nove de JulhoRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Photobiomodulation (PBM) with placebo cosmetic treatment.

Photobiomodulation (PBM) sham with 5% liposomal tranexamic acid cosmetic product

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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
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
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

Secondary Outcome Measures

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)
Photography
Registry of photographs at white and wood lamp
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
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.
Adverse Effects
Registry of any discomfort or unexpected effect of the treatment

Full Information

First Posted
April 8, 2022
Last Updated
June 25, 2023
Sponsor
University of Nove de Julho
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1. Study Identification

Unique Protocol Identification Number
NCT05326997
Brief Title
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

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 1, 2023 (Actual)
Primary Completion Date
September 30, 2024 (Anticipated)
Study Completion Date
December 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Nove de Julho

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Melasma
Keywords
Low Level Laser Therapy (LLLT), Melasma, Photobiomodulation, Tranexamic Acid

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
ParticipantOutcomes Assessor
Masking Description
Neither the participants involved in the study, nor the outcomes assessor will be aware of the groups formed, as well as the treatments received.
Allocation
Randomized
Enrollment
54 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Photobiomodulation (PBM) with placebo cosmetic treatment.
Arm Type
Experimental
Arm Description
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.
Arm Title
Photobiomodulation (PBM) sham with 5% liposomal tranexamic acid cosmetic product
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Photobiomodulation group
Intervention Description
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
Other
Intervention Name(s)
Group control (Tranexamic acid)
Intervention Description
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.
Primary Outcome Measure Information:
Title
MASI (Melasma Area and Severity Index)
Description
Determines the affected area and the severity of Melasma, through visual analysis of the affected site and attribution of scores
Time Frame
Before treatment (week 0).
Title
MASI (Melasma Area and Severity Index)
Description
Determines the affected area and the severity of Melasma, through visual analysis of the affected site and attribution of scores
Time Frame
Half treatment (Week 6)
Title
MASI (Melasma Area and Severity Index)
Description
Determines the affected area and the severity of Melasma, through visual analysis of the affected site and attribution of scores
Time Frame
After the treatments (week 12).
Secondary Outcome Measure Information:
Title
Corneomelametry
Description
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)
Time Frame
Before (week 0), at half (week 6) and after treatment (week 12).
Title
Photography
Description
Registry of photographs at white and wood lamp
Time Frame
Before (week 0), at half (week 6) and after treatment (week 12).
Title
Final global diagnosis of the skin.
Description
Clinical subjective measure with the aid of photographic records, in relation to the change by the severity of Melasma of pigmentation after treatment
Time Frame
Before (week 0), at half (week 6) and after treatment (week 12).
Title
The MELASQoL questionnaire, (Melasma Quality of Life Scale)
Description
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.
Time Frame
Before (week 0), at half (week 6) and after treatment (week 12).
Title
Adverse Effects
Description
Registry of any discomfort or unexpected effect of the treatment
Time Frame
At half (week 6) and after treatment (week 12).

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Christiane Pavani, PhD
Phone
+551133859222
Email
chrispavani@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thais Rodrigues Galache, MSc Fellow
Organizational Affiliation
University of Nove de Julho
Official's Role
Study Chair
Facility Information:
Facility Name
Galache Clinic
City
São Caetano Do Sul
State/Province
São Paulo
ZIP/Postal Code
09550050
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Thais Galache
Phone
4227-0023
Email
thais.galache@uol.com.br
First Name & Middle Initial & Last Name & Degree
Thais Galache
Facility Name
Universidade Nove de Julho
City
São Paulo
ZIP/Postal Code
01504001
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Thais Galache, Master
Phone
+551133859222
First Name & Middle Initial & Last Name & Degree
Christiane Pavani, PhD

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices) will be shared. Researchers who provide a methodologically sound proposal will have access. Proposals should be directed to chrispavani@gmail.com To gain access, data requestors will need to sign a data access agreement.
IPD Sharing Time Frame
Beginning 3 months following article publication
IPD Sharing Access Criteria
Researchers who provide a methodologically sound proposal.

Learn more about this trial

Treatment of Melasma With Yellow Light Compared to Tranexamic Acid

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