Laser Treatment in Early Wound Healing to Promote Physiological Skin Remodeling

Not Applicable

• Conditions: Scar Improvement by Laser
• Interventions: Radiation: NAFL-treatment

• Registration Number: NCT03253484
• Lead Sponsor: Bispebjerg Hospital

Brief Summary

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.

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 Timeline

• Status Verified: 2017-08
• Study First Submitted: 2017-08-11
• Study First Submitted QC: 2017-08-15
• Last Update Submitted: 2017-08-15
• Study Start: 2017-08-18
• Study First Posted: 2017-08-18
• Last Update Posted: 2017-08-18
• Primary Completion: 2018-01-31
• Study Completion: 2018-01-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 32

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
NAFL-treated wounds	NAFL-treatment	NAFL treated wounds

Primary Outcome Measures

Name	Time	Method
Clincial evaluation on Patient observer scar assessement scale (POSAS)	3 months followup	validated scar scale

Secondary Outcome Measures

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