Scar RevisionNCT02050126
Caesarean Scar Revision With the UltraPulse
A study testing Lumenis UltraPulse Encore. in people with Scar Revision, run by Lumenis Be Ltd. at 1 site in Denmark.
Trial summary
Ten (10) adult female subjects that had a caesarean surgery performed.Study will be conducted in 1 site. Each subject will receive three treatments on one area that was randomly chosen. The other area will be left untreated and will serve as a control. Read more about this study
- Who is it for?
- Ages 22 to 55 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Scar Revision
- What is being tested?
- Lumenis UltraPulse Encore.
- 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
- Apr 2013to Jan 2016
- 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
- Healthy volunteers accepted
- Adult
Who may be able to join
- Females in good general health older than 22 years of age and younger than 55 years of age.
- Presenting with a caesarean scar mature and stable caesarean scar (at least 1 year post procedure).
- At least six months following termination of breast feeding.
- Willing to give and sign an informed consent form and a photographic release form.
- Willing to comply with study dosing and complete the entire course of the study .
- Performed negative pregnancy test.
Who cannot join
- Active bacterial, fungal, or viral infection in the treatment area.
- Active cold sores, or herpes in the treatment area.
- Recent excessive exposure to sunlight or artificial UV light (e.g.: use of tanning beds/booths and/or sunbathing) or expectations of tanning during the time of the study .
- History of or the presence of any skin condition/disease that might interfere with the diagnosis or evaluation of study parameters (i.e., atopic dermatitis, eczema, psoriasis).
- Treatment with a systemic retinoid within the past year (e.g., Accutane®, Roche Dermatologics).
- History or presenting with a keloid scar.
Show all 13Show fewer
- Any current or recent treatment for cancer.
- Any uncontrolled systemic disease. A potential subject in whom therapy for a systemic disease is not yet stabilized will not be considered for entry into the study.
- Significant history or current evidence of a medical, psychological or other disorder that, in the investigator's opinion, would preclude enrollment into the study.
- Previous laser treatments on the same scar at least 0.5 year prior to this evaluation.
- Subject planning any other cosmetic procedure to the study area during the study period, other than the treatments that will be performed by the investigator .
- Any other condition that may exclude patient for treatment per physician discretion.
- Female subject who is pregnant, nursing an infant .
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Dermato-venerologisk Afdeling D42
Copenhagen, Bispebjerg Bakke 23, 2400
About this study
Ten (10) adult female subjects that had a caesarean surgery performed.Study will be conducted in 1 site.
Each subject will receive three treatments on one area that was randomly chosen. The other area will be left untreated and will serve as a control.
The objective is to Evaluate the clinical impact of UltraPulse fractional carbon dioxide laser treatment on the appearance of a Caesarean Scar (CS) as compared to a similar untreated scar side.
- Conditions
- Scar Revision
- Being tested
- Lumenis UltraPulse Encore.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lumenis UltraPulse Encore.Device
Treatment using Lumenis UltraPulse Encore.
| Study group | Role | What they receive |
|---|---|---|
| Scar Revision | Experimental | Caesarean Scar Revision using Lumenis UltraPulse Encore. Receives: Device: Lumenis UltraPulse Encore. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Scar Evaluation
VSS , POSAS, Appearance assessment-Evaluation of the scar by blinded investigator.
Measured: 3 month following the 3rd treatment.
Secondary outcomes (6)
Scar Evaluation.
VSS assessment -Evaluation of the scar by blinded investigator.
Measured: At base line , at the 3rd treatment and at the 1, 3 and 6 months follow-up
POSAS assessment
POSAS assessment by blinded Investigator and subject
Measured: At base line , at the 3rd treatment and at the 1, 3 and 6 months follow-up
Scar Thickness and Uniformity
A High Definition Ultrasound (US) device will be used to generate a high resolution image of the skin layers of the treated and non-treated scar in order to measure and compare changes in scar thickness and uniformity.
Measured: At base line, at the 3rd treatment and at the 1, 3 and 6 months follow-up
Scar color
Colorimeter will be used for color measurement.
Measured: At base line, at the 3rd treatment and at the 1, 3 and 6 months follow-up.
Histochemical Changes in scar tissue
Histochemical analysis of scar tissue with different staining for analysis of changes following treatment:
- H\&E staining and histology for collagen arrangement, epidermal rete ridges and measurement of scar depth
- Collagen type I and III staining
- Elastin staining
- Immunohistochemistry for TGF-beta 1, 2, 3 and MMPs
Measured: Immediately before the 2nd, and 3rd treatment
Subject's satisfaction
Subject's satisfaction of the treatment using a Satisfaction Scale as follows: None; Slight; Moderate; Good; Very Good.
Measured: At the 3rd treatment and at the 1, 3 and 6 month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2014 (estimated)
- Study startApr 2013
- Primary completionJan 2016
- Study completionJan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Scar RevisionStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lumenis Be Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Merete Hædersdal, dr. med., ph.d., Principal investigator, Dermato-venerologisk Afdeling D42
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02050126
- Sponsor's protocol ID
- LUM-ABU-UP-12-02
- Status last verified
- Apr 2016
- First submitted
- 28 Jan 2014
- Last updated
- 22 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Caesarean Scar Revision With the UltraPulse
- ClinicalTrials.gov ID
- NCT02050126
- Acronym / sponsor ID
- LUM-ABU-UP-12-02
- Conditions
- Scar Revision
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Lumenis Be Ltd.Industry (pharma, biotech, devices)
- Study start
- Apr 2013
- Primary completion
- Jan 2016 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 30 Jan 2014 (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.
Ten (10) adult female subjects that had a caesarean surgery performed.Study will be conducted in 1 site.
Each subject will receive three treatments on one area that was randomly chosen. The other area will be left untreated and will serve as a control.
The objective is to Evaluate the clinical impact of UltraPulse fractional carbon dioxide laser treatment on the appearance of a Caesarean Scar (CS) as compared to a similar untreated scar side.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Scar Revision | Experimental | Device: Lumenis UltraPulse Encore.Caesarean Scar Revision using Lumenis UltraPulse Encore. |
Who may qualify
- Ages
- 22 to 55 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Females in good general health older than 22 years of age and younger than 55 years of age.
- Presenting with a caesarean scar mature and stable caesarean scar (at least 1 year post procedure).
- At least six months following termination of breast feeding.
- Willing to give and sign an informed consent form and a photographic release form.
- Willing to comply with study dosing and complete the entire course of the study .
Key exclusion criteria (13 listed)
- Active bacterial, fungal, or viral infection in the treatment area.
- Active cold sores, or herpes in the treatment area.
- Recent excessive exposure to sunlight or artificial UV light (e.g.: use of tanning beds/booths and/or sunbathing) or expectations of tanning during the time of the study .
- History of or the presence of any skin condition/disease that might interfere with the diagnosis or evaluation of study parameters (i.e., atopic dermatitis, eczema, psoriasis).
- Treatment with a systemic retinoid within the past year (e.g., Accutane®, Roche Dermatologics).
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 |
|---|---|---|
| Lumenis UltraPulse Encore.Treatment using Lumenis UltraPulse Encore. | Device | Scar Revision |
Primary outcome
Scar Evaluation
Time frame: 3 month following the 3rd treatment.
VSS , POSAS, Appearance assessment-Evaluation of the scar by blinded investigator.
6 secondary outcomes
Scar Evaluation.
Time frame: At base line , at the 3rd treatment and at the 1, 3 and 6 months follow-up
POSAS assessment
Time frame: At base line , at the 3rd treatment and at the 1, 3 and 6 months follow-up
Scar Thickness and Uniformity
Time frame: At base line, at the 3rd treatment and at the 1, 3 and 6 months follow-up
Scar color
Time frame: At base line, at the 3rd treatment and at the 1, 3 and 6 months follow-up.
Histochemical Changes in scar tissue
Time frame: Immediately before the 2nd, and 3rd treatment
Subject's satisfaction
Time frame: At the 3rd treatment and at the 1, 3 and 6 month follow-up
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 22 Apr 2016.
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 Hædersdal, dr. med., ph.d. principal investigator
Dermato-venerologisk Afdeling D42
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lumenis UltraPulse Encore. in people with Scar Revision, run by Lumenis Be Ltd. 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 6 inclusion and 13 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 22 Apr 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?
Scar Evaluation (time frame: 3 month following the 3rd 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 22 Apr 2016; AzTrials last refreshed its copy on 6 Nov 2026.