NCT02651298

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2014

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2014

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2015

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

January 2, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 8, 2016

Completed
Last Updated

January 8, 2016

Status Verified

January 1, 2016

Enrollment Period

1 year

First QC Date

January 2, 2016

Last Update Submit

January 7, 2016

Conditions

Cicatrix

Outcome Measures

Primary Outcomes (1)

  • patient observer scar scale

    validated scar scale evaluations

    up until 6 months post treatment

Secondary Outcomes (7)

  • erythema measured by reflectance

    1 months post treatment

  • pigmentation measured by reflectance

    1 months post treatment

  • erythema measured by reflectance

    3 months post treatment

  • pigmentation measured by reflectance

    3 months post treatment

  • erythema measured by reflectance

    6 months post treatment

  • +2 more secondary outcomes

Study Arms (2)

Fractional CO2-laser

EXPERIMENTAL

3 treatments with fractional co2-laser

Device: Fractional Co2-laser

Untreated control

NO INTERVENTION

untreated control side of caesarean section scar

Interventions

Fractional Co2-laserDEVICE

laser treatment

Also known as: Ablative fractional laser
Fractional CO2-laser

Eligibility Criteria

Age22 Years - 55 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • mature caesarean section scar

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bispebjerg Hospital

Copenhagen, Denmark

Location

MeSH Terms

Conditions

Cicatrix

Condition Hierarchy (Ancestors)

FibrosisPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Merete Haedersdal, Professor

    Bispebjerg Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

January 2, 2016

First Posted

January 8, 2016

Study Start

January 1, 2014

Primary Completion

January 1, 2015

Study Completion

January 1, 2015

Last Updated

January 8, 2016

Record last verified: 2016-01

Locations

DK(1)