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NCT Number: NCT03279003

Study of the Efficacy and Tolerance of Light Therapy 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.

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Key information

Conditions

Sensitive Skin

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHRU de Brest

Brest, 29609, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

LED light

Device

An exposure to LED light will be carried out twice a week until improvement, maximum 8 weeks.

Primary outcomes

  1. Efficacy of light therapy

    Time frame: 2 months

    The improvement of sensitive skin symptoms will be measured by the Sensiscale scale

Secondary outcomes

  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.

Sponsors and collaborators

Lead sponsor

University Hospital, Brest

Other

Registry information

Official study title

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

Acronym: SENSILED

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Sep 12, 2017
Registry last updated
Dec 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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