Clinical trial NCT02050126: Caesarean Scar Revision With the UltraPulse
Official title: Caesarean Scar Revision With the UltraPulse
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Scar Revision
Lead sponsor: Lumenis Be Ltd.
Sponsor class: INDUSTRY
First posted: 2014-01-30
Enrollment: 12
Sex: FEMALE
Minimum age (years): 22
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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:

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 .

Primary outcomes:
measure: Scar Evaluation
timeFrame: 3 month following the 3rd treatment.
Secondary outcomes:
measure: Scar Evaluation.
timeFrame: At base line , at the 3rd treatment and at the 1, 3 and 6 months follow-up
measure: POSAS assessment
timeFrame: At base line , at the 3rd treatment and at the 1, 3 and 6 months follow-up
measure: Scar Thickness and Uniformity
timeFrame: At base line, at the 3rd treatment and at the 1, 3 and 6 months follow-up
measure: Scar color
timeFrame: At base line, at the 3rd treatment and at the 1, 3 and 6 months follow-up.
measure: Histochemical Changes in scar tissue
timeFrame: Immediately before the 2nd, and 3rd treatment
measure: Subject's satisfaction
timeFrame: At the 3rd treatment and at the 1, 3 and 6 month follow-up
Other outcomes:
Locations:
city: København
country: Denmark
facility: Dermato-venerologisk Afdeling D42
state: Bispebjerg Bakke 23
Study officials:
affiliation: Dermato-venerologisk Afdeling D42
name: Merete Hædersdal, dr. med., ph.d.
role: PRINCIPAL_INVESTIGATOR
References: