Caesarean Scar Revision With the UltraPulse

NCT ID: NCT02050126

Last Updated: 2016-04-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-04-30
• Study Completion Date: 2016-01-31

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.

Conditions

Scar Revision

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Scar Revision

Caesarean Scar Revision using Lumenis UltraPulse Encore.

Group Type: EXPERIMENTAL

Lumenis UltraPulse Encore.

Intervention Type: DEVICE

Treatment using Lumenis UltraPulse Encore.

Interventions

Lumenis UltraPulse Encore.

Treatment using Lumenis UltraPulse Encore.

Intervention Type: DEVICE

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 .

• Minimum Eligible Age: 22 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Lumenis Be Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Merete Hædersdal, dr. med., ph.d.

Role: PRINCIPAL_INVESTIGATOR

Dermato-venerologisk Afdeling D42

Locations

Dermato-venerologisk Afdeling D42

Copenhagen, Bispebjerg Bakke 23, Denmark

Countries

Denmark

Other Identifiers

LUM-ABU-UP-12-02

Identifier Type: -

Identifier Source: org_study_id