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

Sensitive Skin Clinical Trial

— SENSILED  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03279003
• Other study ID #: SENSILED (29BRC16.0179)
• Status: Completed
• Phase: N/A
• Start date: June 22, 2018
• Est. completion date: November 12, 2018

Study information

• Verified date: December 2021
• Source: University Hospital, Brest
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: November 12, 2018
• Est. primary completion date: November 12, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Hypersensitivity
• Sensitive Skin

Intervention

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

Locations

Country	Name	City	State
France	CHRU de Brest	Brest

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Brest

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficacy of light therapy	The improvement of sensitive skin symptoms will be measured by the Sensiscale scale	2 months
Secondary	Assessment of pain improvement	Pain improvement will be done by self-evaluation of the patients, using a visual analog scale	2 months
Secondary	Assessment of improvement in pruritus	The improvement of pruritus will be done by self-evaluation of the patients, using a visual analog scale	2 months
Secondary	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.	2 months