HealthyHeaLedNCT02677194
HeaLED: Pilot Study of Skin Healing Under LED Exposure
A study testing LED in people with Healthy, run by Centre Hospitalier Universitaire de Nice.
Trial summary
The aim of this study is to assess cutaneous healing process under LED exposition on 10 healthy subjects pre-treated with fractional CO2 laser on mini-zones on forearms. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- LED
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- No sites listed yet
- Study dates
- Feb 2016to Oct 2017
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- • Male or female aged 18 years or more
- Phototype I to III
- No allergy to topical anesthesia
- Healthy subject with no medical history of dermatological or systemic disease
- Normal homogeneous skin on forearms without excessive hair growth
- No medical history of keloïds or hypertrophic scar
Show all 11Show fewer
- No history of post-inflammatory hyperpigmentation
- No congenital methemoglobinemia or porphyria
- No oral retinoids treatment in the 6 previous months before starting the study
- No Topical or systemic corticosteroids or immunosuppressive or photosensitive drugs in the previous month
- No medical issue that could interfere with the results of the study according to investigator opinion
Who cannot join
- • Subject within exclusion period according to the volunteer national file
- Childbearing or breastfeeding women
- Use of topical cosmetics or drugs in the 48 previous hour before inclusion
- Antalgic treatment in the 24 previous hour before inclusion
About this study
Official title: Stimulation of Cutaneous Healing Processes With LED: a Controlled Comparative Study to Identify Optimal Settings
The aim of this study is to assess cutaneous healing process under LED exposition on 10 healthy subjects pre-treated with fractional CO2 laser on mini-zones on forearms.
Read the detailed description
Cutaneous healing is a physiological process that occurs in many occasions: posttraumatic, post-burn, but also in postsurgery or aesthetic interventions. Most often, topical products are used to create a favorable environment for wound healing.
LED (Light Emitting Diode) are light emitting diodes which produce monochromatic or non-coherent polychromatic radiation when an electric current passes through them. Some LED emitting wavelengths in the visible or near infrared have been reported to promote wound healing. In the literature, in vitro studies showed stimulation of fibroblast and keratinocyte proliferation under the effect of irradiation by the LED. Animal studies have also shown that some LED treatments were able to stimulate healing and angiogenesis. Despite existence of strong data in in vitro and animal studies, the clinical data in humans regarding wound healing are still very poor. Thus, it is still not clear whether the LEDs have a real interest in skin healing, and if so, what are the wavelengths and optimal parameters. Despite this, the LEDs are used widely, unfortunately without a clear demonstration of their effectiveness and without any determination of optimal parameters of treatments that could guide clinicians.
The main objective of the study is to evaluate the efficacy at day 3 of different parameters of LED to enhance wound healing after dermabrasion with CO2 fractional laser on mini-zones on 10 healthy volunteers.
Design of the study:
- screening visit (day-7 to day-21): information of the patient, verification of inclusion criteria , preselection of 7 mini-zones, collection of the informed consent. Clinical examination, vital signs. Pregnancy test for women old enough to procreate.
- V1 (inclusion): clinical examination, vital signs, new pregnancy test for the women old enough to procreate, randomization for the allocation of treatments (LED parameters) on 7 mini-zones of 1,5x1,5 cm at the level of forearm, one of them is allocated to control ( only laser). Dermabrasion by fractional laser CO2 ablative, evaluation of the pain on every zone by VAS post-act. Exposition to LED (630nm, 830nm and 590 nm). Water loss measure and colorimetry before and after laser and after the exposition to LED. Clinical evaluation of local tolerance post-laser and post-LED + standardized photographs. Application of a healing cream twice a day on area treated until healing.
- V2 (24 hours): evaluation local tolerance, photos, colorimetry, waterloss measure before the session LED.
- V3 (48 hours): evaluation local tolerance, photos, colorimetry, waterloss measure before the session LED
- V4 (72 hours): clinical exam, clinical local tolerance evaluation and healing, waterloss measure, colorimetry and standardized photos
- V5 ( J7): evaluation local tolerance, colorimetry and waterloss measures, standardized photos . V6 (J21+/-3 days): clinical exam, clinical local tolerance evaluation and healing, waterloss measure, colorimetry and standardized photos. Final visit of the study
- Conditions
- Healthy
- Being tested
- LED, Control device
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LEDDevice
There are 7 mini-zones of 1,5x1,5 cm at the level of forearm, one of them is allocated to control ( only laser). Dermabrasion by fractional laser CO2 ablative, evaluation of the pain on every zone by VAS post-act. Exposition to LED (630nm, 830nm and 590 nm). Water loss measure and colorimetry before and after laser and after the exposition to LED. Clinical evaluation of local tolerance post-laser and post-LED + standardized photographs.
Control deviceOther
Device without any LED exposition
| Study group | Role | What they receive |
|---|---|---|
| Exposition LED | Experimental | The patient is his own witness. This is a randomization for the allocation of treatments (LED parameters) on 6 mini-zones of 1,5x1,5 cm at the level of forearm. Dermabrasion by fractional laser CO2 ablative, evaluation of the pain on every zone by VAS post-act : exposition to LED 590nm (4 or 12sec) or 630nm(4min30 or 15 min) or 830 nm (6 or 12 min). Receives: Device: LED |
| Control | Other | Device without any LED exposition : This is a randomization for the allocation of treatments (LED parameters) on 6 mini-zones of 1,5x1,5 cm at the level of forearm or control (1 mini-zone) Receives: Other: Control device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of LED treatement
The effect of LED treatment on skin healing will be estimated by measure on colorimetry (day 3 versus day 0)
Measured: at day 3
Secondary outcomes (2)
Waterloss measure
Compare waterloss measure at day 3 (V4) between different LED zones versus control zone by vaporimètre
Measured: at day 3
Tolerance
Describe LED effect on laser tolerance by scale EVA
Measured: at day 3 (V4)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2016 (estimated)
- Study startFeb 2016
- Primary completionApr 2016
- Study completionOct 2017
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 HealthyStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NiceThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nice
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Passeron Thierry, PhD, Principal investigator, Centre Hospitalier Universitaire de Nice
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02677194
- Sponsor's protocol ID
- 14-AOI-12
- Acronym
- HeaLed
- Status last verified
- Mar 2026
- First submitted
- 28 Jan 2016
- Last updated
- 24 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Le Duff F, Fontas E, Guardoli D, Lacour JP, Passeron T. HeaLED: Assessment of skin healing under light-emitting diode (LED) exposure-A randomized controlled study versus placebo. Lasers Surg Med. 2022 Mar;54(3):342-347. doi: 10.1002/lsm.23480. Epub 2021 Sep 16.
PubMed 34529859
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stimulation of Cutaneous Healing Processes With LED: a Controlled Comparative Study to Identify Optimal Settings
- ClinicalTrials.gov ID
- NCT02677194
- Acronym / sponsor ID
- HeaLed / 14-AOI-12
- Conditions
- Healthy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NiceUniversity, hospital or other
- Study start
- Feb 2016 (actual)
- Primary completion
- Apr 2016 (actual)
- Study completion
- Oct 2017 (actual)
- First posted
- 9 Feb 2016 (estimated)
- 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.
The aim of this study is to assess cutaneous healing process under LED exposition on 10 healthy subjects pre-treated with fractional CO2 laser on mini-zones on forearms.
Detailed description
Cutaneous healing is a physiological process that occurs in many occasions: posttraumatic, post-burn, but also in postsurgery or aesthetic interventions. Most often, topical products are used to create a favorable environment for wound healing.
LED (Light Emitting Diode) are light emitting diodes which produce monochromatic or non-coherent polychromatic radiation when an electric current passes through them. Some LED emitting wavelengths in the visible or near infrared have been reported to promote wound healing. In the literature, in vitro studies showed stimulation of fibroblast and keratinocyte proliferation under the effect of irradiation by the LED. Animal studies have also shown that some LED treatments were able to stimulate healing and angiogenesis. Despite existence of strong data in in vitro and animal studies, the clinical data in humans regarding wound healing are still very poor. Thus, it is still not clear whether the LEDs have a real interest in skin healing, and if so, what are the wavelengths and optimal parameters. Despite this, the LEDs are used widely, unfortunately without a clear demonstration of their effectiveness and without any determination of optimal parameters of treatments that could guide clinicians.
The main objective of the study is to evaluate the efficacy at day 3 of different parameters of LED to enhance wound healing after dermabrasion with CO2 fractional laser on mini-zones on 10 healthy volunteers.
Design of the study:
- screening visit (day-7 to day-21): information of the patient, verification of inclusion criteria , preselection of 7 mini-zones, collection of the informed consent. Clinical examination, vital signs. Pregnancy test for women old enough to procreate.
- V1 (inclusion): clinical examination, vital signs, new pregnancy test for the women old enough to procreate, randomization for the allocation of treatments (LED parameters) on 7 mini-zones of 1,5x1,5 cm at the level of forearm, one of them is allocated to control ( only laser). Dermabrasion by fractional laser CO2 ablative, evaluation of the pain on every zone by VAS post-act. Exposition to LED (630nm, 830nm and 590 nm). Water loss measure and colorimetry before and after laser and after the exposition to LED. Clinical evaluation of local tolerance post-laser and post-LED + standardized photographs. Application of a healing cream twice a day on area treated until healing.
- V2 (24 hours): evaluation local tolerance, photos, colorimetry, waterloss measure before the session LED.
- V3 (48 hours): evaluation local tolerance, photos, colorimetry, waterloss measure before the session LED
- V4 (72 hours): clinical exam, clinical local tolerance evaluation and healing, waterloss measure, colorimetry and standardized photos
- V5 ( J7): evaluation local tolerance, colorimetry and waterloss measures, standardized photos . V6 (J21+/-3 days): clinical exam, clinical local tolerance evaluation and healing, waterloss measure, colorimetry and standardized photos. Final visit of the study
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exposition LED | Experimental | Device: LEDThe patient is his own witness. This is a randomization for the allocation of treatments (LED parameters) on 6 mini-zones of 1,5x1,5 cm at the level of forearm. Dermabrasion by fractional laser CO2 ablative, evaluation of the pain on every zone by VAS post-act : exposition to LED 590nm (4 or 12sec) or 630nm(4min30 or 15 min) or 830 nm (6 or 12 min). |
| Control | Other | Other: Control deviceDevice without any LED exposition : This is a randomization for the allocation of treatments (LED parameters) on 6 mini-zones of 1,5x1,5 cm at the level of forearm or control (1 mini-zone) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- • Male or female aged 18 years or more
Key exclusion criteria (4 listed)
- • Subject within exclusion period according to the volunteer national file
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 |
|---|---|---|
| LEDThere are 7 mini-zones of 1,5x1,5 cm at the level of forearm, one of them is allocated to control ( only laser). Dermabrasion by fractional laser CO2 ablative, evaluation of the pain on every zone by VAS post-act. Exposition to LED (630nm, 830nm and 590 nm). Water loss measure and colorimetry before and after laser and after the exposition to LED. Clinical evaluation of local tolerance post-laser and post-LED + standardized photographs. | Device | Exposition LED |
| Control deviceDevice without any LED exposition | Other | Control |
Primary outcome
Effect of LED treatement
Time frame: at day 3
The effect of LED treatment on skin healing will be estimated by measure on colorimetry (day 3 versus day 0)
2 secondary outcomes
Waterloss measure
Time frame: at day 3
Tolerance
Time frame: at day 3 (V4)
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 24 Mar 2026.
- Results publication: PubMed 34529859Le Duff F, Fontas E, Guardoli D, Lacour JP, Passeron T. HeaLED: Assessment of skin healing under light-emitting diode (LED) exposure-A randomized controlled study versus placebo. Lasers Surg Med. 2022 Mar;54(3):342-347. doi: 10.1002/lsm.23480. Epub 2021 Sep 16.
- Individual participant dataSharing planned: No
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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.
Passeron Thierry, PhD principal investigator
Centre Hospitalier Universitaire de Nice
Questions about this trial
What is this clinical trial studying?
A study testing LED in people with Healthy, run by Centre Hospitalier Universitaire de Nice.
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 11 inclusion and 4 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 24 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
Effect of LED treatement (time frame: at day 3). 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 NCT02677194, 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 24 Mar 2026.