- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03877445
Study of the Influence of Blue Light Emitted by Computer / Television Screens on Melasma MELABLUE Study (MELABLUE)
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
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.
Study Overview
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Nice, France
- Centre de Pharmacologie Clinique Appliquée à la Dermatologie
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: Melasma Group exposed left half-face by ORIEL solar simulator
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.
|
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
|
|
Other: Melasma Group exposed right half-face by ORIEL solar simulator
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.
|
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
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
|
15 days
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
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
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15 days
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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
|
15 days
|
Collaborators and Investigators
Investigators
- Principal Investigator: Thierry PASSERON, MD, PhD, Centre Hospitalier Universitaire de Nice
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 19-PP-02
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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