HeaLED: Pilot Study of Skin Healing Under LED Exposure

NCT02677194 | Completed

• 1 other identifier: 14-AOI-12
• Study Type: interventional
• Target: 10
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (2)

• Waterloss measure

  at day 3

• Tolerance

  at day 3 (V4)

Study Arms (2)

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).

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)

Other: Control device

Interventions

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.

Exposition LED

Control device OTHER

Device without any LED exposition

Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Childbearing or breastfeeding women

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nice: lead

Related Publications (1)

• 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.

  PMID: 34529859 RESULT

Study Officials

• Passeron Thierry, PhD

  Centre Hospitalier Universitaire de Nice

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 28, 2016
• First Posted: February 9, 2016
• Study Start: February 1, 2016
• Primary Completion: April 1, 2016
• Study Completion: October 1, 2017
• Last Updated: March 24, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share