HeaLED: Pilot Study of Skin Healing Under LED Exposure

NCT ID: NCT02677194

Last Updated: 2018-02-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-02-29
• Study Completion Date: 2017-10-31

Brief 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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Exposition LED

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).

Group Type: EXPERIMENTAL

LED

Intervention Type: 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.

Control

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)

Group Type: OTHER

Control device

Intervention Type: OTHER

Device without any LED exposition

Interventions

LED

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.

Intervention Type: DEVICE

Control device

Device without any LED exposition

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• • 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
• 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

Exclusion Criteria

• • 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Centre Hospitalier Universitaire de Nice

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Passeron Thierry, PhD

Role: PRINCIPAL_INVESTIGATOR

Centre Hospitalier Universitaire de Nice

Other Identifiers

14-AOI-12

Identifier Type: -

Identifier Source: org_study_id