Treatment of Breast Lift/Reduction Scars

NCT05123508 | Withdrawn FDA Device

• 1 other identifier: SCARCIP001
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Scars

Keywords

Breast reduction scars; Breast lift scars

Outcome Measures

Primary Outcomes (1)

• Improvement in surgical scars

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

  3 months

Secondary Outcomes (2)

• Overall improvement

  3 months

• Overall Improvement

  3 months

Study Arms (2)

Treatment Arm

EXPERIMENTAL

2940nm laser and BBL treatment

Device: 2940nm and BBL treatment

Control Arm

EXPERIMENTAL

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

Other: Non-treatment side (Control)

Interventions

2940nm and BBL treatment DEVICE

2940nm and BBL treatment

Treatment Arm

Non-treatment side (Control) OTHER

No treatment

Control Arm

Eligibility Criteria

• Age: 25 Years - 60 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sciton: lead

Study Sites (2)

AboutSkin Research, LLC

Greenwood Village, Colorado, 80111, United States

Location

Sanctuary Plastic Surgery

Boca Raton, Florida, 33431, United States

Location

MeSH Terms

Conditions

Cicatrix

Condition Hierarchy (Ancestors)

Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Joel Cohen, MD

  AboutSkin Research, LLC

  PRINCIPAL INVESTIGATOR

• Jason Pozner, MD

  Sanctuary Plastic Surgery

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Treatment arm and control arm

Study Record Dates

• First Submitted: June 22, 2021
• First Posted: November 17, 2021
• Study Start: June 30, 2021
• Primary Completion: October 21, 2021
• Study Completion: October 21, 2021
• Last Updated: November 29, 2021

Record last verified: 2021-11

Locations

US (2)