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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT05123508
Other study ID # SCARCIP001
Secondary ID
Status Withdrawn
Phase N/A
First received
Last updated
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
Health authority
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Status Withdrawn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.

Study Design


Related Conditions & MeSH terms


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
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