Early Intervention With Non-ablative Fractional Laser to Reduce Cutaneous Scarring

Cicatrix Clinical Trial

Official title:

Early Intervention With Non-ablative Fractional Laser to Reduce Cutaneous Scarring

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02645773
• Other study ID #: Early intevention
• Status: Completed
• Phase: N/A
• First received: December 30, 2015
• Last updated: February 8, 2016
• Start date: September 2015
• Est. completion date: January 2016

Study information

• Verified date: February 2016
• Source: Bispebjerg Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

To investigate intervention with early application of non-ablative laser to prevent scarring in the skin

Description:

To intervene in scar formation at three different time-points

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: January 2016
• Est. primary completion date: December 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• good health

• men

• Skin type 2-3

• non-smokers

• presenting full medical record

Exclusion Criteria:

• active skin disease in test area

• resent UV-exposure in test area

• history of keloid

• current or resent cancer

• uncontrolled systemical disease

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Cicatrix

Intervention

Device:
• non-ablative laser
non-abaltive laser pre, immediate and post wounding

Locations

Country	Name	City	State
Denmark	Bispebjerg Hospital	Copenhagen

Sponsors (1)

Lead Sponsor	Collaborator
Bispebjerg Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To measure the clinical effect on scarring of non-ablative laser intervention at the three time-points	Clinical evaluation by scar scales	3 months after	No