Treatment of Breast Lift/Reduction Scars

Treatment of Surgical Scars Following Breast Lifts/Reductions

Laser and light treatment for surgical scars following breast lifts/reductions

Study Overview

• Status: Withdrawn
• Conditions: Scars
• Intervention / Treatment: Device: 2940nm and BBL treatment; Other: Non-treatment side (Control)

Detailed Description

The purpose of the study is to demonstrate effectiveness of laser and light therapy for the treatment of surgical scars following breast lifts/reductions.

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Colorado
    • Greenwood Village, Colorado, United States, 80111
      • AboutSkin Research, LLC
  • Florida
    • Boca Raton, Florida, United States, 33431
      • Sanctuary Plastic Surgery

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

1. Healthy female subjects between 25 to 60 years of age inclusive
2. Fitzpatrick skin type I-IV
3. Subjects with post-surgical breast lift/reduction scar
4. A maximum of 8-10 weeks since surgery
5. Healed surgery wound in the treatment area
6. Willing to have photographs taken of the treatment area
7. Can read, understand and sign informed consent form (English only)
8. Has indicated willingness to participate in the study by signing an informed consent form
9. Agrees to adhere to the treatment and follow-up schedule and post treatment care instructions

Exclusion Criteria:

1. Fitzpatrick skin type V-VI
2. Breast reconstruction with radiation treatment
3. Is pregnant and/or lactating
4. Has tattoos, dysplastic nevi in the treatment area
5. History or current photosensitivity
6. History or current use of medication with photosensitizing properties within past 6 months
7. History or current of chronic reoccurring skin disease or disorder affecting treatment area
8. History or current cancer of any type
9. Has hormonal disorder
10. Has signs of actinic bronzing
11. Has open lacerations, and abrasions on the treatment area
12. History of keloid formation, or hypertrophic scar formation, or poor wound healing
13. History of bleeding disorder, or is currently taking anticoagulation medications
14. Has significant concurrent illnesses (controlled or uncontrolled), such as diabetes, lupus, epilepsy, or cardiac disorders, which might be aggravated as a result of treatment
15. Has participated in any clinical trial involving an investigational drug, device or cosmetic product or procedure within the past 30 days
16. The investigator feels that for any reason the subject is not eligible to participate in the study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment Arm; 2940nm laser and BBL treatment	Device: 2940nm and BBL treatment; 2940nm and BBL treatment
Experimental: Control Arm; One side of the treatment area will act as a control. No treatment on the control side.	Other: Non-treatment side (Control); No treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Improvement in surgical scars	Degree of improvement in scars using photographs assessed via modified Vancouver scar scale	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall improvement	The Patient and Observer Scar Scale (POSAS)	3 months
Overall Improvement	Global Aesthetic Improvement Scale (GAIS)	3 months

Collaborators and Investigators

• Sponsor: Sciton
• Investigators: Principal Investigator: Joel Cohen, MD, AboutSkin Research, LLC; Principal Investigator: Jason Pozner, MD, Sanctuary Plastic Surgery

Study record dates

Study Major Dates

• Study Start (Actual): June 30, 2021
• Primary Completion (Actual): October 21, 2021
• Study Completion (Actual): October 21, 2021

Study Registration Dates

• First Submitted: June 22, 2021
• First Submitted That Met QC Criteria: November 5, 2021
• First Posted (Actual): November 17, 2021

Study Record Updates

• Last Update Posted (Actual): November 29, 2021
• Last Update Submitted That Met QC Criteria: November 17, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Keywords: Breast reduction scars; Breast lift scars
• Additional Relevant MeSH Terms: Pathologic Processes; Fibrosis; Cicatrix
• Other Study ID Numbers: SCARCIP001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes