Study of the Efficacy and Tolerance of Light Therapy in Sensitive Skin
SENSILED
1 other identifier
interventional
30
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jun 2018
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 1, 2017
CompletedFirst Posted
Study publicly available on registry
September 12, 2017
CompletedStudy Start
First participant enrolled
June 22, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 12, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
November 12, 2018
CompletedDecember 3, 2025
December 1, 2021
5 months
September 1, 2017
November 26, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Efficacy of light therapy
The improvement of sensitive skin symptoms will be measured by the Sensiscale scale
2 months
Secondary Outcomes (3)
Assessment of pain improvement
2 months
Assessment of improvement in pruritus
2 months
Assessment of the tolerance
2 months
Study Arms (1)
Light-emitting diode therapy
EXPERIMENTALExposure to LED light
Interventions
An exposure to LED light will be carried out twice a week until improvement, maximum 8 weeks.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
CHRU de Brest
Brest, 29609, France
Related Publications (1)
Sonbol H, Brenaut E, Nowak E, Misery L. Efficacy and Tolerability of Phototherapy With Light-Emitting Diodes for Sensitive Skin: A Pilot Study. Front Med (Lausanne). 2020 Feb 7;7:35. doi: 10.3389/fmed.2020.00035. eCollection 2020.
PMID: 32118019RESULT
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 1, 2017
First Posted
September 12, 2017
Study Start
June 22, 2018
Primary Completion
November 12, 2018
Study Completion
November 12, 2018
Last Updated
December 3, 2025
Record last verified: 2021-12