Study of the Influence of Blue Light Emitted by Computer / Television Screens on Melasma MELABLUE Study (MELABLUE)
Primary Purpose
Melasma
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
exposition half-face
Sponsored by
About this trial
This is an interventional other trial for Melasma
Eligibility Criteria
Inclusion Criteria:
- Female patient, 18 years of age and older, phototype II to V on the Fitzpatrick scale
- Patient with a clinically diagnosed diagnosis of melasma.
- Patient without a serious medical history and declared fit to participate in the medical visit.
- Patient who has signed a written informed consent form before any action related to the study is initiated.
- If the patient is able to procreate, she should use reliable contraception (contraceptive pill, contraceptive implant, intrauterine contraceptive device, bilateral tubal ligation / section, condoms), and agree not to change contraceptive status for at least one month before the start of the study and throughout the duration of the study.
Exclusion Criteria:
- Women who are pregnant or breastfeeding or who have planned a pregnancy during the course of the study.
- Patient with another pigment condition on the face.
- Patient who used depigmenting cosmetic on the face in the two weeks prior to inclusion.
- Patient who used a local corticosteroid on the face or systemic steroids during the month prior to inclusion.
- Patient who used local tretinoin or local hydroquinone during the month prior to inclusion.
- Patient who took systemic or topical photosensitizing treatments during the month preceding the first day of the study (1 month or 5 half-lives, the longest possible duration),
- Patient with a history of photodermatoses.
- Patient spending more than 3 hours a day in front of a screen (computer, LED TV, tablet, phone etc ...) for professional or private reasons.
Sites / Locations
- Centre de Pharmacologie Clinique Appliquée à la Dermatologie
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
Melasma Group exposed left half-face by ORIEL solar simulator
Melasma Group exposed right half-face by ORIEL solar simulator
Arm Description
Twelve patients will be included in the study and exposed on a half-face from Day1 to Day5. The other half-face will serve as unexposed control.
Twelve patients will be included in the study and exposed on a half-face from Day1 to Day5. The other half-face will serve as unexposed control.
Outcomes
Primary Outcome Measures
Evaluate the effect of blue light emitted by computer / television screens on the intensity of pigmentation of melasma by Melasma Area and Severity Index scale
Secondary Outcome Measures
Evaluate the tolerance and the possible undesirable effects induced by the exposure in blue light with Melasma Area and Severity Index scale
Evaluate the effect of blue light emitted by computer / television screens on the intensity of pigmentation of healthy skin by chomametry
Full Information
NCT ID
NCT03877445
First Posted
March 13, 2019
Last Updated
December 6, 2019
Sponsor
Centre Hospitalier Universitaire de Nice
1. Study Identification
Unique Protocol Identification Number
NCT03877445
Brief Title
Study of the Influence of Blue Light Emitted by Computer / Television Screens on Melasma MELABLUE Study
Acronym
MELABLUE
Official Title
Study of the Influence of Blue Light Emitted by Computer / Television Screens on Melasma Single-center, Interventional, Randomized, Single-blind Study (Masked Investigator) MELABLUE Study
Study Type
Interventional
2. Study Status
Record Verification Date
December 2019
Overall Recruitment Status
Completed
Study Start Date
April 11, 2019 (Actual)
Primary Completion Date
April 11, 2019 (Actual)
Study Completion Date
July 22, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Nice
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
Melasma is a fairly common condition resulting in hyperpigmented macules on the face. Melasma is difficult to treat and has a significant negative impact on the patient's quality of life.
Melasma is worsen when exposed to high energy visible light (blue and violet light) of the solar spectrum. Blue light emitted by LED screens from computers, tablets, televisions and even mobile phones is currently suspected (via media channels) to induce harmful effects on the skin, including pigmentation and photoaging. These screens, however, emit much lower irradiances than those of the solar spectrum, and the probability that these irradiances impact the skin is very low.
The objective of the study is to assess the effect of blue light emitted by computer/television screens on the intensity of melasma pigmentation. To do this, it is proposed to use maximized conditions that could be encountered in normal daily life, namely a simulation of blue light exposure (420-490nm) at 20 cm from a laptop LED screen, 8 hours a day for 5 days. Since it is not proposed to expose a person for 8 hours a day, a solar simulator with appropriate filters will be used to emit a spectrum of between 420 and 490 nm with a compatible intensity for an acceptable duration of exposure (around 30 minutes a day).
Twelve patients will be included in the study and exposed on a half-face from Day1 to Day5. The other half-face will serve as unexposed control. The effect of blue light on the melasma lesions will be assessed from Day 1 to Day 6 using chromametry and a modified MASI on standardized photographs. A final evaluation visit will be performed at Day 15.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Melasma
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
12 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Melasma Group exposed left half-face by ORIEL solar simulator
Arm Type
Other
Arm Description
Twelve patients will be included in the study and exposed on a half-face from Day1 to Day5. The other half-face will serve as unexposed control.
Arm Title
Melasma Group exposed right half-face by ORIEL solar simulator
Arm Type
Other
Arm Description
Twelve patients will be included in the study and exposed on a half-face from Day1 to Day5. The other half-face will serve as unexposed control.
Intervention Type
Device
Intervention Name(s)
exposition half-face
Intervention Description
Patients will be included in the study and exposed on a half-face from Day1 to Day5. The other half-face will serve as unexposed control. The effect of blue light on the melasma lesions will be assessed from Day 1 to Day 6 using chromametry and a modified Melasma Area and Severity Index on standardized photographs
Primary Outcome Measure Information:
Title
Evaluate the effect of blue light emitted by computer / television screens on the intensity of pigmentation of melasma by Melasma Area and Severity Index scale
Time Frame
15 days
Secondary Outcome Measure Information:
Title
Evaluate the tolerance and the possible undesirable effects induced by the exposure in blue light with Melasma Area and Severity Index scale
Time Frame
15 days
Title
Evaluate the effect of blue light emitted by computer / television screens on the intensity of pigmentation of healthy skin by chomametry
Time Frame
15 days
10. Eligibility
Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Female patient, 18 years of age and older, phototype II to V on the Fitzpatrick scale
Patient with a clinically diagnosed diagnosis of melasma.
Patient without a serious medical history and declared fit to participate in the medical visit.
Patient who has signed a written informed consent form before any action related to the study is initiated.
If the patient is able to procreate, she should use reliable contraception (contraceptive pill, contraceptive implant, intrauterine contraceptive device, bilateral tubal ligation / section, condoms), and agree not to change contraceptive status for at least one month before the start of the study and throughout the duration of the study.
Exclusion Criteria:
Women who are pregnant or breastfeeding or who have planned a pregnancy during the course of the study.
Patient with another pigment condition on the face.
Patient who used depigmenting cosmetic on the face in the two weeks prior to inclusion.
Patient who used a local corticosteroid on the face or systemic steroids during the month prior to inclusion.
Patient who used local tretinoin or local hydroquinone during the month prior to inclusion.
Patient who took systemic or topical photosensitizing treatments during the month preceding the first day of the study (1 month or 5 half-lives, the longest possible duration),
Patient with a history of photodermatoses.
Patient spending more than 3 hours a day in front of a screen (computer, LED TV, tablet, phone etc ...) for professional or private reasons.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thierry PASSERON, MD, PhD
Organizational Affiliation
Centre Hospitalier Universitaire de Nice
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre de Pharmacologie Clinique Appliquée à la Dermatologie
City
Nice
Country
France
12. IPD Sharing Statement
Learn more about this trial
Study of the Influence of Blue Light Emitted by Computer / Television Screens on Melasma MELABLUE Study
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