ScarsNCT05123508
Treatment of Breast Lift/Reduction Scars
A study testing 2940nm and BBL treatment in people with Scars, run by Sciton at 2 sites in United States.
Trial summary
Laser and light treatment for surgical scars following breast lifts/reductions Read more about this study
- Who is it for?
- Ages 25 to 60 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Scars
- What is being tested?
- 2940nm and BBL treatment
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 2 sitesUnited States
- Study dates
- 30 Jun 2021to 21 Oct 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 60 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Show all 9Show fewer
- 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
Who cannot join
- 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
Show all 16Show fewer
- 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
- The investigator feels that for any reason the subject is not eligible to participate in the study.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Sanctuary Plastic Surgery
Boca Raton, Florida, 33431
AboutSkin Research, LLC
Greenwood Village, Colorado, 80111
About this study
Official title: Treatment of Surgical Scars Following Breast Lifts/Reductions
Laser and light treatment for surgical scars following breast lifts/reductions
Read the 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.
- Conditions
- Scars
- Being tested
- 2940nm and BBL treatment, Non-treatment side (Control)
- Keywords
- Breast reduction scars, Breast lift scars
- Medical subject headings
- Cicatrix
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
2940nm and BBL treatmentDevice
2940nm and BBL treatment
Non-treatment side (Control)Other
No treatment
| Study group | Role | What they receive |
|---|---|---|
| Treatment Arm | Experimental | 2940nm laser and BBL treatment Receives: 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. Receives: Other: Non-treatment side (Control) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement in surgical scars
Degree of improvement in scars using photographs assessed via modified Vancouver scar scale
Measured: 3 months
Secondary outcomes (2)
Overall improvement
The Patient and Observer Scar Scale (POSAS)
Measured: 3 months
Overall Improvement
Global Aesthetic Improvement Scale (GAIS)
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2021
- Study start30 Jun 2021
- Primary completion21 Oct 2021
- Study completion21 Oct 2021
Why it stopped: No subjects enrolled
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ScarsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Treatment arm and control arm
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sciton
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Joel Cohen, MD, Principal investigator, AboutSkin Research, LLCJason Pozner, MD, Principal investigator, Sanctuary Plastic Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05123508
- Sponsor's protocol ID
- SCARCIP001
- Status last verified
- Nov 2021
- First submitted
- 22 Jun 2021
- Last updated
- 29 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Surgical Scars Following Breast Lifts/Reductions
- ClinicalTrials.gov ID
- NCT05123508
- Acronym / sponsor ID
- SCARCIP001
- Conditions
- Scars
- Keywords
- Breast reduction scars, Breast lift scars
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No subjects enrolled
- Enrolment
- 0 participants (actual)
- Lead sponsor
- ScitonIndustry (pharma, biotech, devices)
- Study start
- 30 Jun 2021 (actual)
- Primary completion
- 21 Oct 2021 (actual)
- Study completion
- 21 Oct 2021 (actual)
- First posted
- 17 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Treatment arm and control arm
| Arm | Type | Receives |
|---|---|---|
| Treatment Arm | Experimental | Device: 2940nm and BBL treatment2940nm laser and BBL treatment |
| Control Arm | Experimental | Other: Non-treatment side (Control)One side of the treatment area will act as a control. No treatment on the control side. |
Who may qualify
- Ages
- 25 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 2940nm and BBL treatment2940nm and BBL treatment | Device | Treatment Arm |
| Non-treatment side (Control)No treatment | Other | Control Arm |
Primary outcome
Improvement in surgical scars
Time frame: 3 months
Degree of improvement in scars using photographs assessed via modified Vancouver scar scale
2 secondary outcomes
Overall improvement
Time frame: 3 months
Overall Improvement
Time frame: 3 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2021.
Related trials for Scars
Recruiting
A Study Assessing Arrhythmia Mapping With a Multi-Electrode Mapping Catheter
Scar-related Atrial Tachycardia, Persistent Atrial Fibrillation
Recruiting
Clinical Impact of Uterine Repair During Cesarean Section With Barbed Suture on the Incidence of Isthmocele
Isthmocele, Cesarean Scar Defect
Active, not recruiting
Clinical Study to Evaluate the Safety and Efficacy of Candela Technology
Hair Reduction, Tattoo Removal
Recruiting
Surgical Outcomes of Simple Interrupted Versus Running Epidermal Sutures in Full-thickness Skin Graft Placement
Skin Graft Scar
Recruiting
Management of Abdominal Post-surgical Scar With Ozoaqua Versus Standard Care
Wound Healing, Abdominal Surgery
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joel Cohen, MD principal investigator
AboutSkin Research, LLC
Jason Pozner, MD principal investigator
Sanctuary Plastic Surgery
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 2940nm and BBL treatment in people with Scars, run by Sciton at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 29 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement in surgical scars (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Nov 2021; AzTrials last refreshed its copy on 7 Nov 2026.