Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
NA
INTERVENTIONAL
2021-06-30
2021-10-21
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Treatment Arm
2940nm laser and BBL treatment
2940nm and BBL treatment
2940nm and BBL treatment
Control Arm
One side of the treatment area will act as a control. No treatment on the control side.
Non-treatment side (Control)
No treatment
Interventions
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2940nm and BBL treatment
2940nm and BBL treatment
Non-treatment side (Control)
No treatment
Eligibility Criteria
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Inclusion Criteria
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
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.
25 Years
60 Years
FEMALE
Yes
Sponsors
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Sciton
INDUSTRY
Responsible Party
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Principal Investigators
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Joel Cohen, MD
Role: PRINCIPAL_INVESTIGATOR
AboutSkin Research, LLC
Jason Pozner, MD
Role: PRINCIPAL_INVESTIGATOR
Sanctuary Plastic Surgery
Locations
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AboutSkin Research, LLC
Greenwood Village, Colorado, United States
Sanctuary Plastic Surgery
Boca Raton, Florida, United States
Countries
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Other Identifiers
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SCARCIP001
Identifier Type: -
Identifier Source: org_study_id