Laser Treatment in Early Wound Healing to Promote Physiol... | NCT03253484

Studies
Laser Treatment in Early Wound Healing to Promote Physiological Skin Remodeling

NCT03253484

Sponsor

Bispebjerg Hospital

Status

Unknown status

Last Update Posted

Aug 18, 2017Actual

Enrollment

32Estimated

Phase

Not Applicable

Conditions

Scar Improvement by Laser

Interventions

NAFL-treatment

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2017

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 18, 2017Estimated

Primary Completion Date

Jan 31, 2018Estimated

Completion Date

Jan 31, 2018Estimated

First Submitted Date

Aug 11, 2017

First Submission Date that Met QC Criteria

Aug 15, 2017

First Posted Date

Aug 18, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 15, 2017

Last Update Posted Date

Aug 18, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

32Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
NAFL-treated wounds	Experimental	NAFL treated wounds	Radiation: NAFL-treatment
Control	No Intervention	untreated control wound

Interventions

Name	Type	Description	Arm Group Labels	Other Names
NAFL-treatment	Radiation	non ablative fractional laser 15 40 nm promoting wound healing and reduction of scar formation	NAFL-treated wounds

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Clincial evaluation on Patient observer scar assessement scale (POSAS)	validated scar scale	3 months followup

Secondary Outcomes

Measure	Description	Time Frame
Photoevaluation on visual analogue scale	3 independent dermatologists will evaluate on VAS	3 months follow-up
Reflectance measurement	measurement of erythema and pigment

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
30101519	Derived	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.