CicatrixNCT02651298
CO2-laser Treatment for Caesarean Section Scars
A study testing Fractional Co2-laser in people with Cicatrix, run by Bispebjerg Hospital at 1 site in Denmark.
Trial summary
Fractional Co2-laser for treatment of mature caesarean section scars. Read more about this study
- Who is it for?
- Ages 22 to 55 years, women only
- Conditions the study is for
- Cicatrix
- What is being tested?
- Fractional Co2-laser
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteDenmark
- Study dates
- Jan 2014to Jan 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 to 55 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- mature caesarean section scar
Who cannot join
- systemic uncontrolled disease
- recent or current cancer
- smoking
- keloid formation
- wounds or local disease int treatment area
- pregnancy or lactation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Fractional CO2-laser Treatment of Caesarean Section Scars - A Randomized Controlled Split-scar Trial With Long Term Follow-up Assessment
Fractional Co2-laser for treatment of mature caesarean section scars.
Read the detailed description
Randomized split scar study to document improvement of caesarean section scars as compared to untreated control scar.
- Conditions
- Cicatrix
- Being tested
- Fractional Co2-laser
- Medical subject headings
- Cicatrix
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fractional Co2-laserDevice
Also called Ablative fractional laser
laser treatment
| Study group | Role | What they receive |
|---|---|---|
| Fractional CO2-laser | Experimental | 3 treatments with fractional co2-laser Receives: Device: Fractional Co2-laser |
| Untreated control | No intervention | untreated control side of caesarean section scar |
What is being measured
The primary outcome is the main question the study is designed to answer.
patient observer scar scale
validated scar scale evaluations
Measured: up until 6 months post treatment
Secondary outcomes (7)
erythema measured by reflectance
measured by reflectance
Measured: 1 months post treatment
pigmentation measured by reflectance
measured by reflectance
Measured: 1 months post treatment
erythema measured by reflectance
measured by reflectance
Measured: 3 months post treatment
pigmentation measured by reflectance
measured by reflectance
Measured: 3 months post treatment
erythema measured by reflectance
measured by reflectance
Measured: 6 months post treatment
pigmentation measured by reflectance
measured by reflectance
Measured: 6 months post treatment
histology of scar tissue
Measured: 3 months post treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2016 (estimated)
- Study startJan 2014
- Primary completionJan 2015
- Study completionJan 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CicatrixStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bispebjerg Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Lumenis Be Ltd.
- Responsible party
- Principal investigator, Katrine Elisabeth Karmisholt, Bispebjerg Hospital
- Investigators
- Merete Haedersdal, Professor, Principal investigator, Bispebjerg Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02651298
- Sponsor's protocol ID
- C-section
- Status last verified
- Jan 2016
- First submitted
- 2 Jan 2016
- Last updated
- 8 Jan 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fractional CO2-laser Treatment of Caesarean Section Scars - A Randomized Controlled Split-scar Trial With Long Term Follow-up Assessment
- ClinicalTrials.gov ID
- NCT02651298
- Acronym / sponsor ID
- C-section
- Conditions
- Cicatrix
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Bispebjerg HospitalUniversity, hospital or other
- Collaborators
- Lumenis Be Ltd.
- Study start
- Jan 2014
- Primary completion
- Jan 2015 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 8 Jan 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fractional CO2-laser | Experimental | Device: Fractional Co2-laser3 treatments with fractional co2-laser |
| Untreated control | No intervention | –untreated control side of caesarean section scar |
Who may qualify
- Ages
- 22 to 55 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- mature caesarean section scar
Key exclusion criteria (6 listed)
- systemic uncontrolled disease
- recent or current cancer
- smoking
- keloid formation
- wounds or local disease int treatment area
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fractional Co2-laserAlso: Ablative fractional laserlaser treatment | Device | Fractional CO2-laser |
Primary outcome
patient observer scar scale
Time frame: up until 6 months post treatment
validated scar scale evaluations
7 secondary outcomes
erythema measured by reflectance
Time frame: 1 months post treatment
pigmentation measured by reflectance
Time frame: 1 months post treatment
erythema measured by reflectance
Time frame: 3 months post treatment
pigmentation measured by reflectance
Time frame: 3 months post treatment
erythema measured by reflectance
Time frame: 6 months post treatment
pigmentation measured by reflectance
Time frame: 6 months post treatment
histology of scar tissue
Time frame: 3 months post treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2016.
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Microbiome
Active, not recruitingPhase 4
Residual Disease MEMory in PSOriasis Skin During EnstiLAR® and Narrow-band Ultraviolet B Therapy: The MEMPSOLAR Study
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Merete Haedersdal, Professor principal investigator
Bispebjerg Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fractional Co2-laser in people with Cicatrix, run by Bispebjerg Hospital at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
patient observer scar scale (time frame: up until 6 months post treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jan 2016.