Study of the Efficacy and Tolerance of Light Therapy in Sensitive Skin (SENSILED)

November 26, 2025 updated by: University Hospital, Brest

Study of the Efficacy and Tolerance of Light Therapy by Light-emitting Diode (LED) in Sensitive Skin

Light-emitting diode (LED) light therapy is increasingly used successfully and without adverse effects in diabetic leg ulcer, chronic low back pain, chronic myofacial pain in the neck and in several dermatoses such as acne, Psoriasis, alopecia areata and skin rejuvenation. A Korean study conducted in 2013 suggested its effectiveness in patients with sensitive skin in connection with rosacea, acne, eczema. The objective of the study is to perform a study in subjects with a sensitive skin without associated dermatosis.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The objective of the study is to evaluate the efficacy of light-emitting diode therapy in subjects with sensitive skin and to assess pain improvement, evaluation of improvement in pruritus and evaluation of treatment tolerance.

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Brest, France, 29609
        • CHRU de Brest

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 66 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Age greater than or equal to 18 years
  • Age less than or equal to 70
  • Sensitive skin defined by a score ≥ 40 on the Sensiscale scale
  • Patient able to consent

Exclusion Criteria:

  • Persons under 18 years of age or over.
  • Persons suffering from disorders of higher functions preventing comprehension of the questionnaire.
  • Pregnancy.
  • Analgesic or medication acting on the nervous system.
  • Other dermatosis of the face (example: rosacea, seborrheic dermatitis, acne ...).
  • Neurological or psychiatric illness.
  • A photosensitizing drug.
  • Refusal of patient
  • Patients under legal protection

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Light-emitting diode therapy
Exposure to LED light
Device: LED light
An exposure to LED light will be carried out twice a week until improvement, maximum 8 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Efficacy of light therapy
Time Frame: 2 months
The improvement of sensitive skin symptoms will be measured by the Sensiscale scale
2 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assessment of pain improvement
Time Frame: 2 months
Pain improvement will be done by self-evaluation of the patients, using a visual analog scale
2 months
Assessment of improvement in pruritus
Time Frame: 2 months
The improvement of pruritus will be done by self-evaluation of the patients, using a visual analog scale
2 months
Assessment of the tolerance
Time Frame: 2 months
At the end of the study, patients will be questioned about the possible occurrence of side effects listed in the patient's notebook during the 8 weeks of treatment.
2 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Brest

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 22, 2018

Primary Completion (Actual)

November 12, 2018

Study Completion (Actual)

November 12, 2018

Study Registration Dates

First Submitted

September 1, 2017

First Submitted That Met QC Criteria

September 8, 2017

First Posted (Actual)

September 12, 2017

Study Record Updates

Last Update Posted (Estimated)

December 3, 2025

Last Update Submitted That Met QC Criteria

November 26, 2025

Last Verified

December 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SENSILED (29BRC16.0179)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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