Back to results

CO2-laser Treatment for Caesarean Section Scars

Primary Purpose

Cicatrix

Status

Completed

Phase

Not Applicable

Locations

Denmark

Study Type

Interventional

Intervention

Fractional Co2-laser

About this trial

This is an interventional treatment trial for Cicatrix

Eligibility Criteria

22 Years - 55 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

mature caesarean section scar

Exclusion Criteria:

systemic uncontrolled disease
recent or current cancer
smoking
keloid formation
wounds or local disease int treatment area
pregnancy or lactation

Sites / Locations

Bispebjerg Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Fractional CO2-laser

Untreated control

Arm Description

3 treatments with fractional co2-laser

untreated control side of caesarean section scar

Outcomes

Primary Outcome Measures

patient observer scar scale

validated scar scale evaluations

Secondary Outcome Measures

erythema measured by reflectance

measured by reflectance

pigmentation measured by reflectance

measured by reflectance

erythema measured by reflectance

measured by reflectance

pigmentation measured by reflectance

measured by reflectance

erythema measured by reflectance

measured by reflectance

pigmentation measured by reflectance

measured by reflectance

histology of scar tissue

Full Information

NCT ID

NCT02651298

First Posted

January 2, 2016

Last Updated

January 7, 2016

Sponsor

Bispebjerg Hospital

Collaborators

Lumenis Be Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT02651298

Brief Title

CO2-laser Treatment for Caesarean Section Scars

Official Title

Fractional CO2-laser Treatment of Caesarean Section Scars - A Randomized Controlled Split-scar Trial With Long Term Follow-up Assessment

Study Type

Interventional

2. Study Status

Record Verification Date

January 2016

Overall Recruitment Status

Completed

Study Start Date

January 2014 (undefined)

Primary Completion Date

January 2015 (Actual)

Study Completion Date

January 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Bispebjerg Hospital

Collaborators

Lumenis Be Ltd.

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

Fractional Co2-laser for treatment of mature caesarean section scars.

Detailed Description

Randomized split scar study to document improvement of caesarean section scars as compared to untreated control scar.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cicatrix

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantOutcomes Assessor

Allocation

Randomized

Enrollment

12 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Fractional CO2-laser

Arm Type

Experimental

Arm Description

3 treatments with fractional co2-laser

Arm Title

Untreated control

Arm Type

No Intervention

Arm Description

untreated control side of caesarean section scar

Intervention Type

Device

Intervention Name(s)

Fractional Co2-laser

Other Intervention Name(s)

Ablative fractional laser

Intervention Description

laser treatment

Primary Outcome Measure Information:

Title

patient observer scar scale

Description

validated scar scale evaluations

Time Frame

up until 6 months post treatment

Secondary Outcome Measure Information:

Title

erythema measured by reflectance

Description

measured by reflectance

Time Frame

1 months post treatment

Title

pigmentation measured by reflectance

Description

measured by reflectance

Time Frame

1 months post treatment

Title

erythema measured by reflectance

Description

measured by reflectance

Time Frame

3 months post treatment

Title

pigmentation measured by reflectance

Description

measured by reflectance

Time Frame

3 months post treatment

Title

erythema measured by reflectance

Description

measured by reflectance

Time Frame

6 months post treatment

Title

pigmentation measured by reflectance

Description

measured by reflectance

Time Frame

6 months post treatment

Title

histology of scar tissue

Time Frame

3 months post treatment

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

22 Years

Maximum Age & Unit of Time

55 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: mature caesarean section scar Exclusion Criteria: systemic uncontrolled disease recent or current cancer smoking keloid formation wounds or local disease int treatment area pregnancy or lactation

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Merete Haedersdal, Professor

Organizational Affiliation

Bispebjerg Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Bispebjerg Hospital

City

Copenhagen

Country

Denmark

12. IPD Sharing Statement

Learn more about this trial

CO2-laser Treatment for Caesarean Section Scars

We'll reach out to this number within 24 hrs