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

Sponsor
Centre Hospitalier Universitaire de Nice (Other)
Overall Status
Completed
CT.gov ID
NCT03877445
Collaborator
(none)
12
1
2
3.4
3.6

Study Details

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
  • Device: exposition half-face
N/A

Study Design

Study Type:
Interventional
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 :
Apr 11, 2019
Actual Primary Completion Date :
Apr 11, 2019
Actual Study Completion Date :
Jul 22, 2019

Arms and Interventions

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.

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

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.

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 [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 [15 days]

  2. Evaluate the effect of blue light emitted by computer / television screens on the intensity of pigmentation of healthy skin by chomametry [15 days]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
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

Site City State Country Postal Code
1 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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Centre Hospitalier Universitaire de Nice
ClinicalTrials.gov Identifier:
NCT03877445
Other Study ID Numbers:
  • 19-PP-02
First Posted:
Mar 15, 2019
Last Update Posted:
Dec 9, 2019
Last Verified:
Dec 1, 2019
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Dec 9, 2019