Laser Treatment in Early Wound Healing to Promote Physiological Skin Remodeling

NCT ID: NCT03253484

Last Updated: 2017-08-18

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-08-18
• Study Completion Date: 2018-01-31

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.

Conditions

Scar Improvement by Laser

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

NAFL-treated wounds

NAFL treated wounds

Group Type: EXPERIMENTAL

NAFL-treatment

Intervention Type: RADIATION

non ablative fractional laser 15 40 nm promoting wound healing and reduction of scar formation

Control

untreated control wound

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

NAFL-treatment

non ablative fractional laser 15 40 nm promoting wound healing and reduction of scar formation

Intervention Type: RADIATION

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bispebjerg Hospital

OTHER

Sponsor Role: lead

Responsible Party

Katrine Elisabeth Karmisholt

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

References

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.

Reference Type: DERIVED

PMID: 30101519 (View on PubMed)

Other Identifiers

H-17012492

Identifier Type: -

Identifier Source: org_study_id