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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.
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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). |
|
| 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) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LED | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Effect of LED treatement | The effect of LED treatment on skin healing will be estimated by measure on colorimetry (day 3 versus day 0) | at day 3 |
| Measure | Description | Time Frame |
|---|---|---|
| Waterloss measure | Compare waterloss measure at day 3 (V4) between different LED zones versus control zone by vaporimètre | at day 3 |
| Tolerance | Describe LED effect on laser tolerance by scale EVA |
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Inclusion Criteria:
• Male or female aged 18 years or more
Exclusion Criteria:
• Subject within exclusion period according to the volunteer national file
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| Name | Affiliation | Role |
|---|---|---|
| Passeron Thierry, PhD | Centre Hospitalier Universitaire de Nice | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34529859 | Result | 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. |
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|
| Control device | Other | Device without any LED exposition |
|
| at day 3 (V4) |