CClinicalTrials.gg
Sign In
CompletedNCT02050126Updated Apr 22, 2016

Caesarean Scar Revision With the UltraPulse

An interventional study of Lumenis UltraPulse Encore. in Scar Revision, sponsored by Lumenis Be Ltd.. Completed at 1 site in Denmark. Open to female participants aged 22 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-04-22.

Sponsored by Lumenis Be Ltd. · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
12
Allocation
Not applicable
Ages
22 Years to 55 Years
Sex
Female
01

Study 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.

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.

02

Conditions studied

  • Scar Revision
03

In context

Lead sponsor

Lumenis Be Ltd. is the lead sponsor of 32 studies on the registry; 5 are open to participants now.

Of its 7 completed or terminated interventional studies of FDA-regulated products, 1 (14%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
22 Years to 55 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

Inclusion criteria

  1. Females in good general health older than 22 years of age and younger than 55 years of age.
  2. Presenting with a caesarean scar mature and stable caesarean scar (at least 1 year post procedure).
  3. At least six months following termination of breast feeding.
  4. Willing to give and sign an informed consent form and a photographic release form.
  5. Willing to comply with study dosing and complete the entire course of the study .
  6. Performed negative pregnancy test.

Exclusion criteria

Exclusion Criteria:

  1. Active bacterial, fungal, or viral infection in the treatment area.
  2. Active cold sores, or herpes in the treatment area.
  3. 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 .
  4. 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).
  5. Treatment with a systemic retinoid within the past year (e.g., Accutane®, Roche Dermatologics).
  6. History or presenting with a keloid scar.
  7. Any current or recent treatment for cancer.
  8. 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.
  9. Significant history or current evidence of a medical, psychological or other disorder that, in the investigator's opinion, would preclude enrollment into the study.
  10. Previous laser treatments on the same scar at least 0.5 year prior to this evaluation.
  11. 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 .
  12. Any other condition that may exclude patient for treatment per physician discretion.
  13. Female subject who is pregnant, nursing an infant .
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
12 participants (actual)

Study arms

  • Experimental
    Scar Revision

    Caesarean Scar Revision using Lumenis UltraPulse Encore.

    Device: Lumenis UltraPulse Encore.

Interventions

  • DeviceLumenis UltraPulse Encore.

    Treatment using Lumenis UltraPulse Encore.

06

What researchers measure

Primary outcomes

  1. Scar Evaluation

    VSS , POSAS, Appearance assessment-Evaluation of the scar by blinded investigator.

    Time frame: 3 month following the 3rd treatment.

Secondary outcomes

  1. Scar Evaluation.

    VSS assessment -Evaluation of the scar by blinded investigator.

    Time frame: At base line , at the 3rd treatment and at the 1, 3 and 6 months follow-up

  2. POSAS assessment

    POSAS assessment by blinded Investigator and subject

    Time frame: At base line , at the 3rd treatment and at the 1, 3 and 6 months follow-up

  3. 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.

    Time frame: At base line, at the 3rd treatment and at the 1, 3 and 6 months follow-up

  4. Scar color

    Colorimeter will be used for color measurement.

    Time frame: At base line, at the 3rd treatment and at the 1, 3 and 6 months follow-up.

  5. 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

    Time frame: Immediately before the 2nd, and 3rd treatment

  6. Subject's satisfaction

    Subject's satisfaction of the treatment using a Satisfaction Scale as follows: None; Slight; Moderate; Good; Very Good.

    Time frame: At the 3rd treatment and at the 1, 3 and 6 month follow-up

07

Study locations

1 site
  • Dermato-venerologisk Afdeling D42
    København, Bispebjerg Bakke 23 2400, Denmark
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 22, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02050126
Lead sponsor
Lumenis Be Ltd.
Responsible party
Sponsor
First posted
Jan 30, 2014
Start date
Apr 2013
Primary completion
Jan 2016
Completion
Jan 2016
Last update
Apr 22, 2016

Study contacts

Merete Hædersdal, dr. med., ph.d.
principal investigator · Dermato-venerologisk Afdeling D42

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2016. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies from this sponsor

Lumenis Be Ltd.

Start the discussion