Laser Treatment in Early Wound Healing to Promote Physiological Skin Remodeling

Scar Improvement by Laser Clinical Trial

Official title:

Laser Treatment in Early Wound Healing to Promote Physiological Skin Remodeling

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03253484
• Other study ID #: H-17012492
• Status: Not yet recruiting
• Phase: N/A
• First received: August 11, 2017
• Last updated: August 15, 2017
• Start date: August 18, 2017
• Est. completion date: January 31, 2018

Study information

• Verified date: August 2017
• Source: Bispebjerg Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 32
• Est. completion date: January 31, 2018
• Est. primary completion date: January 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Scar Improvement by Laser

Intervention

Radiation:
• NAFL-treatment
non ablative fractional laser 15 40 nm promoting wound healing and reduction of scar formation

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bispebjerg Hospital

Outcome

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