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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03279003
Recruitment Status : Unknown
Verified September 2017 by University Hospital, Brest.
Recruitment status was:  Not yet recruiting
First Posted : September 12, 2017
Last Update Posted : September 12, 2017
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Sensitive Skin Device: LED light Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Study of the Efficacy and Tolerance of Light Therapy by Light-emitting Diode (LED) in Sensitive Skin
Estimated Study Start Date : November 2017
Estimated Primary Completion Date : July 2018
Estimated Study Completion Date : September 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Allergy

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.




Primary Outcome Measures :
  1. Efficacy of light therapy [ Time Frame: 2 months ]
    The improvement of sensitive skin symptoms will be measured by the Sensiscale scale


Secondary Outcome Measures :
  1. 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. 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

  3. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03279003


Contacts
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Contact: Laurent Misery, Professor 02 98 22 33 15 ext +33 laurent.misery@chu-brest.fr

Sponsors and Collaborators
University Hospital, Brest
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Responsible Party: University Hospital, Brest
ClinicalTrials.gov Identifier: NCT03279003    
Other Study ID Numbers: SENSILED (29BRC16.0179)
First Posted: September 12, 2017    Key Record Dates
Last Update Posted: September 12, 2017
Last Verified: September 2017

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hypersensitivity
Immune System Diseases