Laser Treatment in Early Wound Healing to Promote Physiological Skin Remodeling

The primary objective of this study is to explore the potential clinical effect of targeting surgical wounds in all three wound healing phases by non ablative fractional laser (NAFL) to reduce scar formation in a randomized controlled trial. Thus, NAFL will be applied during 1) inflammation phase (0-3 days) as represented by NAFL-treatment adjacent to surgical wounding, 2) proliferation phase (4-21 days) by NAFL-treatment immediately after suture removal and 3) remodeling phase (21 days-1 year) by NAFL-treatment six weeks after surgery.

Study Overview

• Status: Unknown
• Conditions: Scar Improvement by Laser
• Intervention / Treatment: Radiation: NAFL-treatment

Detailed Description

This is a prospective, randomized, controlled, assessor - blinded, intra-individual trial comparing laser exposed skin lesions to untreated control skin lesions in a split scar set-up to investigate efficacy. The study will be performed on patients undergoing an excision at Bispebjerg Dermatological Department. One randomly allocated part of each included wound will receive three NAFL-treatments and the other part will serve as untreated control wound. Scars will be evaluated clinically on-site by blinded evaluator immediately before third treatment and 3 months after NAFL-treatments. The clinical data will be supplemented by blinded photo-evaluation, patients' evaluation and non-invasive measurements.

• Study Type: Interventional
• Enrollment (Anticipated): 32
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• o Subjects referred to excision of either benign, pre malignant or malignant non-melanoma skin cancer (NMSC) lesions.

  • The length of postoperative wound should be estimated to minimum 2.5 cm and may be located on any region of the body
  • Minimum 18 years old
  • Presenting full medical record report at study initiation
  • Fitzpatrick skin type I-III
  • Non-smokers
  • Written informed consent obtained from subject
  • Understanding of investigation procedures and willingness to abide to all procedures during the course of the investigation

Exclusion Criteria:

• o History of or presenting with a keloid scar

  • A subject with a systemic disease not yet stabilized
  • If the patient is pregnant
  • Visible recent sun exposure in test area
  • Significant history or current evidence of a medical, psychological or other disorder that, in the investigator's opinion, would preclude enrollment into the study
  • Current use of topical treatment and lack of willingness to refrain from future use of topical treatment, such as i.e. silicone products, that potentially can interfere with the test results
  • Unable to follow the outlined study protocol

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: NAFL-treated wounds; NAFL treated wounds	Radiation: NAFL-treatment; non ablative fractional laser 15 40 nm promoting wound healing and reduction of scar formation
No Intervention: Control; untreated control wound

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clincial evaluation on Patient observer scar assessement scale (POSAS)	validated scar scale	3 months followup

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Photoevaluation on visual analogue scale	3 independent dermatologists will evaluate on VAS	3 months follow-up
Reflectance measurement	measurement of erythema and pigment	3 months followup
Clinical evaluation on Vancouver Scar Scale	validated scar scale	3 months followup
Clincial evaluation on Patient observer scar assessement scale (POSAS)	validated scar scale	1month follow-up
Clinical evaluation on Vancouver Scar Scale	validated scar scale	1month follow-up and

Collaborators and Investigators

• Sponsor: Bispebjerg Hospital

Publications and helpful links

General Publications

• Karmisholt KE, Banzhaf CA, Glud M, Yeung K, Paasch U, Nast A, Haedersdal M. Laser treatments in early wound healing improve scar appearance: a randomized split-wound trial with nonablative fractional laser exposures vs. untreated controls. Br J Dermatol. 2018 Dec;179(6):1307-1314. doi: 10.1111/bjd.17076. Epub 2018 Sep 30.

Study record dates

Study Major Dates

• Study Start (Anticipated): August 18, 2017
• Primary Completion (Anticipated): January 31, 2018
• Study Completion (Anticipated): January 31, 2018

Study Registration Dates

• First Submitted: August 11, 2017
• First Submitted That Met QC Criteria: August 15, 2017
• First Posted (Actual): August 18, 2017

Study Record Updates

• Last Update Posted (Actual): August 18, 2017
• Last Update Submitted That Met QC Criteria: August 15, 2017
• Last Verified: August 1, 2017

More Information

Terms related to this study

• Keywords: scar NAFL laser
• Other Study ID Numbers: H-17012492

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No