Study of the Influence of Blue Light Emitted by Computer / Television Screens on Melasma MELABLUE Study (MELABLUE)

• ClinicalTrials.gov Identifier: NCT03877445
• Recruitment Status: Completed
• First Posted: March 15, 2019
• Last Update Posted: December 9, 2019
• Sponsor: Centre Hospitalier Universitaire de Nice
• Information provided by (Responsible Party): Centre Hospitalier Universitaire de Nice

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.

Condition or disease	Intervention/treatment	Phase
Melasma	Device: exposition half-face	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 12 participants
• Allocation: Randomized
• Intervention Model: Single Group Assignment
• Masking: Single (Investigator)
• Primary Purpose: Other
• 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
• Actual Study Start Date: April 11, 2019
• Actual Primary Completion Date: April 11, 2019
• Actual Study Completion Date: July 22, 2019

Arms and Interventions

Arm	Intervention/treatment
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.	Device: exposition half-face; 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
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.	Device: exposition half-face; 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

Outcome Measures

Primary Outcome Measures :

1. 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 Measures :

1. 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 ]
2. 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 ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: Female
• Gender Based Eligibility: Yes
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

France

Centre de Pharmacologie Clinique Appliquée à la Dermatologie

Nice, France

Sponsors and Collaborators

Centre Hospitalier Universitaire de Nice

Investigators

• Principal Investigator: Thierry PASSERON, MD, PhD; Centre Hospitalier Universitaire de Nice

More Information

• Responsible Party: Centre Hospitalier Universitaire de Nice
• ClinicalTrials.gov Identifier: NCT03877445
• Other Study ID Numbers: 19-PP-02
• First Posted: March 15, 2019
• Last Update Posted: December 9, 2019
• Last Verified: December 2019

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Melanosis; Hyperpigmentation; Pigmentation Disorders; Skin Diseases