Clinical trial NCT03253484: Laser Treatment in Early Wound Healing to Promote Physiological Skin Remodeling
Official title: Laser Treatment in Early Wound Healing to Promote Physiological Skin Remodeling
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Scar Improvement by Laser
Keywords: scar NAFL laser
Lead sponsor: Bispebjerg Hospital
Sponsor class: OTHER
First posted: 2017-08-18
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: split scar study
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Clincial evaluation on Patient observer scar assessement scale (POSAS)
timeFrame: 3 months followup
Secondary outcomes:
measure: Photoevaluation on visual analogue scale
timeFrame: 3 months follow-up
measure: Reflectance measurement
timeFrame: 3 months followup
measure: Clinical evaluation on Vancouver Scar Scale
timeFrame: 3 months followup
measure: Clincial evaluation on Patient observer scar assessement scale (POSAS)
timeFrame: 1month follow-up
measure: Clinical evaluation on Vancouver Scar Scale
timeFrame: 1month follow-up and
Other outcomes:
Locations:
Study officials:
References:
citation: 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.