Sensitive SkinSENSILEDNCT03279003
Study of the Efficacy and Tolerance of Light Therapy in Sensitive Skin
A study testing LED light in people with Sensitive Skin, run by University Hospital, Brest at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Sensitive Skin
- What is being tested?
- LED light
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- 22 Jun 2018to 12 Nov 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
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- A photosensitizing drug.
- Refusal of patient
- Patients under legal protection
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Study of the Efficacy and Tolerance of Light Therapy by Light-emitting Diode (LED) 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.
Read the 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.
- Conditions
- Sensitive Skin
- Being tested
- LED light
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LED lightDevice
An exposure to LED light will be carried out twice a week until improvement, maximum 8 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Light-emitting diode therapy | Experimental | Exposure to LED light Receives: Device: LED light |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy of light therapy
The improvement of sensitive skin symptoms will be measured by the Sensiscale scale
Measured: 2 months
Secondary outcomes (3)
Assessment of pain improvement
Pain improvement will be done by self-evaluation of the patients, using a visual analog scale
Measured: 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
Measured: 2 months
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.
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2017
- Study start22 Jun 2018
- Primary completion12 Nov 2018
- Study completion12 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Sensitive SkinStudies of the same condition, open and under way.
- More trials run by University Hospital, BrestThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Brest
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03279003
- Sponsor's protocol ID
- SENSILED (29BRC16.0179)
- Acronym
- SENSILED
- Status last verified
- Dec 2021
- First submitted
- 1 Sep 2017
- Last updated
- 3 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 32118019
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Efficacy and Tolerance of Light Therapy by Light-emitting Diode (LED) in Sensitive Skin
- ClinicalTrials.gov ID
- NCT03279003
- Acronym / sponsor ID
- SENSILED / SENSILED (29BRC16.0179)
- Conditions
- Sensitive Skin
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University Hospital, BrestUniversity, hospital or other
- Study start
- 22 Jun 2018 (actual)
- Primary completion
- 12 Nov 2018 (actual)
- Study completion
- 12 Nov 2018 (actual)
- First posted
- 12 Sep 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Light-emitting diode therapy | Experimental | Device: LED lightExposure to LED light |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (9 listed)
- 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 ...).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LED lightAn exposure to LED light will be carried out twice a week until improvement, maximum 8 weeks. | Device | Light-emitting diode therapy |
Primary outcome
Efficacy of light therapy
Time frame: 2 months
The improvement of sensitive skin symptoms will be measured by the Sensiscale scale
3 secondary outcomes
Assessment of pain improvement
Time frame: 2 months
Assessment of improvement in pruritus
Time frame: 2 months
Assessment of the tolerance
Time frame: 2 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2025.
- Results publication: PubMed 32118019Sonbol 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LED light in people with Sensitive Skin, run by University Hospital, Brest at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy of light therapy (time frame: 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03279003, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Dec 2025.