Treatment of Breast Lift/Reduction Scars

Scars Clinical Trial

Official title:

Treatment of Surgical Scars Following Breast Lifts/Reductions

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT05123508
• Other study ID #: SCARCIP001
• Status: Withdrawn
• Phase: N/A
• Start date: June 30, 2021
• Est. completion date: October 21, 2021

Study information

• Verified date: November 2021
• Source: Sciton
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: October 21, 2021
• Est. primary completion date: October 21, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 25 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cicatrix
• Scars

Intervention

Device:
• 2940nm and BBL treatment
2940nm and BBL treatment

Other:
• Non-treatment side (Control)
No treatment

Locations

Country	Name	City	State
United States	Sanctuary Plastic Surgery	Boca Raton	Florida
United States	AboutSkin Research, LLC	Greenwood Village	Colorado

Sponsors (1)

Lead Sponsor	Collaborator
Sciton

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Improvement in surgical scars	Degree of improvement in scars using photographs assessed via modified Vancouver scar scale	3 months
Secondary	Overall improvement	The Patient and Observer Scar Scale (POSAS)	3 months
Secondary	Overall Improvement	Global Aesthetic Improvement Scale (GAIS)	3 months