Laser Treatment in Early Wound Healing to Promote Physiological Skin Remodeling

• ClinicalTrials.gov Identifier: NCT03253484
• Recruitment Status: Unknown
• First Posted: August 18, 2017
• Last Update Posted: August 18, 2017
• Sponsor: Bispebjerg Hospital
• Information provided by (Responsible Party): Katrine Elisabeth Karmisholt, Bispebjerg Hospital

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Scar Improvement by Laser	Radiation: NAFL-treatment	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 32 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: split scar study
• Masking: Single (Outcomes Assessor)
• Masking Description: the outcome assessor will not know which side is the treated side of scar
• Primary Purpose: Treatment
• Official Title: Laser Treatment in Early Wound Healing to Promote Physiological Skin Remodeling
• Estimated Study Start Date: August 18, 2017
• Estimated Primary Completion Date: January 31, 2018
• Estimated Study Completion Date: January 31, 2018

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

1. Clincial evaluation on Patient observer scar assessement scale (POSAS) [ Time Frame: 3 months followup ]
   validated scar scale

Secondary Outcome Measures :

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

Eligibility Criteria

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

Criteria

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

Contacts and Locations

No Contacts or Locations Provided

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: Katrine Elisabeth Karmisholt, MD, Bispebjerg Hospital
• ClinicalTrials.gov Identifier: NCT03253484 History of Changes
• Other Study ID Numbers: H-17012492
• First Posted: August 18, 2017
• Last Update Posted: August 18, 2017
• Last Verified: August 2017

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• 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

Keywords provided by Katrine Elisabeth Karmisholt, Bispebjerg Hospital:

scar NAFL laser