Clinical trial NCT05123508: Treatment of Breast Lift/Reduction Scars
Official title: Treatment of Surgical Scars Following Breast Lifts/Reductions
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Scars
Keywords: Breast reduction scars
Breast lift scars
Lead sponsor: Sciton
Sponsor class: INDUSTRY
First posted: 2021-11-17
Enrollment: 0
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Treatment arm and control arm
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Improvement in surgical scars
timeFrame: 3 months
Secondary outcomes:
measure: Overall improvement
timeFrame: 3 months
measure: Overall Improvement
timeFrame: 3 months
Other outcomes:
Locations:
city: Greenwood Village
country: United States
facility: AboutSkin Research, LLC
state: Colorado
city: Boca Raton
country: United States
facility: Sanctuary Plastic Surgery
state: Florida
Study officials:
affiliation: AboutSkin Research, LLC
name: Joel Cohen, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Sanctuary Plastic Surgery
name: Jason Pozner, MD
role: PRINCIPAL_INVESTIGATOR
References: