Back to resultsStudy of the Efficacy and Tolerance of Light Therapy in Sensitive Skin (SENSILED)
Primary Purpose
Sensitive Skin
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
LED light
Sponsored by
About this trial
This is an interventional treatment trial for Sensitive Skin
Eligibility Criteria
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
Sites / Locations
- CHRU de Brest
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Light-emitting diode therapy
Arm Description
Exposure to LED light
Outcomes
Primary Outcome Measures
Efficacy of light therapy
The improvement of sensitive skin symptoms will be measured by the Sensiscale scale
Secondary Outcome Measures
Assessment of pain improvement
Pain improvement will be done by self-evaluation of the patients, using a visual analog scale
Assessment of improvement in pruritus
The improvement of pruritus will be done by self-evaluation of the patients, using a visual analog scale
Assessment of the tolerance
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.
Full Information
NCT ID
NCT03279003
First Posted
September 1, 2017
Last Updated
December 10, 2021
Sponsor
University Hospital, Brest
1. Study Identification
Unique Protocol Identification Number
NCT03279003
Brief Title
Study of the Efficacy and Tolerance of Light Therapy in Sensitive Skin
Acronym
SENSILED
Official Title
Study of the Efficacy and Tolerance of Light Therapy by Light-emitting Diode (LED) in Sensitive Skin
Study Type
Interventional
2. Study Status
Record Verification Date
December 2021
Overall Recruitment Status
Completed
Study Start Date
June 22, 2018 (Actual)
Primary Completion Date
November 12, 2018 (Actual)
Study Completion Date
November 12, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Brest
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sensitive Skin
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Light-emitting diode therapy
Arm Type
Experimental
Arm Description
Exposure to LED light
Intervention Type
Device
Intervention Name(s)
LED light
Intervention Description
An exposure to LED light will be carried out twice a week until improvement, maximum 8 weeks.
Primary Outcome Measure Information:
Title
Efficacy of light therapy
Description
The improvement of sensitive skin symptoms will be measured by the Sensiscale scale
Time Frame
2 months
Secondary Outcome Measure Information:
Title
Assessment of pain improvement
Description
Pain improvement will be done by self-evaluation of the patients, using a visual analog scale
Time Frame
2 months
Title
Assessment of improvement in pruritus
Description
The improvement of pruritus will be done by self-evaluation of the patients, using a visual analog scale
Time Frame
2 months
Title
Assessment of the tolerance
Description
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.
Time Frame
2 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
CHRU de Brest
City
Brest
ZIP/Postal Code
29609
Country
France
12. IPD Sharing Statement
Learn more about this trial
Study of the Efficacy and Tolerance of Light Therapy in Sensitive Skin
We'll reach out to this number within 24 hrs