Study of the Efficacy and Tolerance of Light Therapy in S... | NCT03279003

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

NCT03279003

Sponsor

University Hospital, Brest

Status

Completed

Last Update Posted

Dec 3, 2025Actual

Enrollment

30Actual

Phase

Not Applicable

Conditions

Sensitive Skin

Interventions

LED light

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 22, 2018Actual

Primary Completion Date

Nov 12, 2018Actual

Completion Date

Nov 12, 2018Actual

First Submitted Date

Sep 1, 2017

First Submission Date that Met QC Criteria

Sep 8, 2017

First Posted Date

Sep 12, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 26, 2025

Last Update Posted Date

Dec 3, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

30Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Light-emitting diode therapy	Experimental	Exposure to LED light	Device: LED light

Interventions

Name	Type	Description	Arm Group Labels	Other Names
LED light	Device	An exposure to LED light will be carried out twice a week until improvement, maximum 8 weeks.	Light-emitting diode therapy

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Efficacy of light therapy	The improvement of sensitive skin symptoms will be measured by the Sensiscale scale	2 months

Secondary Outcomes

Measure	Description	Time Frame
Assessment of pain improvement	Pain improvement will be done by self-evaluation of the patients, using a visual analog scale	2 months
Assessment of improvement in pruritus	The improvement of pruritus will be done by self-evaluation of the patients, using a visual analog scale

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Facility	Status	City	State	ZIP	Country	Contacts
CHRU de Brest		Brest		29609	France

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
32118019	Result	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.