Study of the Efficacy and Tolerance of Light Therapy in Sensitive Skin

Not Applicable

Completed

• Conditions: Sensitive Skin
• Interventions: Device: LED light

• Registration Number: NCT03279003
• Lead Sponsor: University Hospital, Brest

Brief Summary

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.

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 Timeline

• Study First Submitted: 2017-09-01
• Study First Submitted QC: 2017-09-08
• Study First Posted: 2017-09-12
• Study Start: 2018-06-22
• Primary Completion: 2018-11-12
• Study Completion: 2018-11-12
• Status Verified: 2021-12
• Last Update Submitted: 2021-12-10
• Last Update Posted: 2021-12-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Light-emitting diode therapy	LED light	Exposure to LED light

Primary Outcome Measures

Name	Time	Method
Efficacy of light therapy	2 months	The improvement of sensitive skin symptoms will be measured by the Sensiscale scale

Secondary Outcome Measures

Name	Time	Method
Assessment of pain improvement	2 months	Pain improvement will be done by self-evaluation of the patients, using a visual analog scale
Assessment of the tolerance	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.
Assessment of improvement in pruritus	2 months	The improvement of pruritus will be done by self-evaluation of the patients, using a visual analog scale

Trial Locations

Locations (1)

CHRU de Brest; 🇫🇷 Brest, France