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Treatment of Breast Lift/Reduction Scars

Primary Purpose

Scars

Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
2940nm and BBL treatment
Non-treatment side (Control)
Sponsored by
Sciton
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Scars focused on measuring Breast reduction scars, Breast lift scars

Eligibility Criteria

25 Years - 60 Years (Adult)FemaleAccepts Healthy Volunteers

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.

Sites / Locations

  • AboutSkin Research, LLC
  • Sanctuary Plastic Surgery

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Treatment Arm

Control Arm

Arm Description

2940nm laser and BBL treatment

One side of the treatment area will act as a control. No treatment on the control side.

Outcomes

Primary Outcome Measures

Improvement in surgical scars
Degree of improvement in scars using photographs assessed via modified Vancouver scar scale

Secondary Outcome Measures

Overall improvement
The Patient and Observer Scar Scale (POSAS)
Overall Improvement
Global Aesthetic Improvement Scale (GAIS)

Full Information

First Posted
June 22, 2021
Last Updated
November 17, 2021
Sponsor
Sciton
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1. Study Identification

Unique Protocol Identification Number
NCT05123508
Brief Title
Treatment of Breast Lift/Reduction Scars
Official Title
Treatment of Surgical Scars Following Breast Lifts/Reductions
Study Type
Interventional

2. Study Status

Record Verification Date
November 2021
Overall Recruitment Status
Withdrawn
Why Stopped
No subjects enrolled
Study Start Date
June 30, 2021 (Actual)
Primary Completion Date
October 21, 2021 (Actual)
Study Completion Date
October 21, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sciton

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Scars
Keywords
Breast reduction scars, Breast lift scars

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Treatment arm and control arm
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment Arm
Arm Type
Experimental
Arm Description
2940nm laser and BBL treatment
Arm Title
Control Arm
Arm Type
Experimental
Arm Description
One side of the treatment area will act as a control. No treatment on the control side.
Intervention Type
Device
Intervention Name(s)
2940nm and BBL treatment
Intervention Description
2940nm and BBL treatment
Intervention Type
Other
Intervention Name(s)
Non-treatment side (Control)
Intervention Description
No treatment
Primary Outcome Measure Information:
Title
Improvement in surgical scars
Description
Degree of improvement in scars using photographs assessed via modified Vancouver scar scale
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Overall improvement
Description
The Patient and Observer Scar Scale (POSAS)
Time Frame
3 months
Title
Overall Improvement
Description
Global Aesthetic Improvement Scale (GAIS)
Time Frame
3 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Healthy female subjects between 25 to 60 years of age inclusive Fitzpatrick skin type I-IV Subjects with post-surgical breast lift/reduction scar A maximum of 8-10 weeks since surgery Healed surgery wound in the treatment area Willing to have photographs taken of the treatment area Can read, understand and sign informed consent form (English only) Has indicated willingness to participate in the study by signing an informed consent form Agrees to adhere to the treatment and follow-up schedule and post treatment care instructions Exclusion Criteria: Fitzpatrick skin type V-VI Breast reconstruction with radiation treatment Is pregnant and/or lactating Has tattoos, dysplastic nevi in the treatment area History or current photosensitivity History or current use of medication with photosensitizing properties within past 6 months History or current of chronic reoccurring skin disease or disorder affecting treatment area History or current cancer of any type Has hormonal disorder Has signs of actinic bronzing Has open lacerations, and abrasions on the treatment area History of keloid formation, or hypertrophic scar formation, or poor wound healing History of bleeding disorder, or is currently taking anticoagulation medications Has significant concurrent illnesses (controlled or uncontrolled), such as diabetes, lupus, epilepsy, or cardiac disorders, which might be aggravated as a result of treatment Has participated in any clinical trial involving an investigational drug, device or cosmetic product or procedure within the past 30 days The investigator feels that for any reason the subject is not eligible to participate in the study.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joel Cohen, MD
Organizational Affiliation
AboutSkin Research, LLC
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jason Pozner, MD
Organizational Affiliation
Sanctuary Plastic Surgery
Official's Role
Principal Investigator
Facility Information:
Facility Name
AboutSkin Research, LLC
City
Greenwood Village
State/Province
Colorado
ZIP/Postal Code
80111
Country
United States
Facility Name
Sanctuary Plastic Surgery
City
Boca Raton
State/Province
Florida
ZIP/Postal Code
33431
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Treatment of Breast Lift/Reduction Scars

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