Pilot Evaluation of Smart vs HERO Broadband Light Treatment for Pigmented Skin Lesions

NCT04936919 | Completed FDA Device

• 1 other identifier: BBLCIP002
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of the study is to investigate the effects of Intense Pulsed Broad Band Light for treatment of pigmented lesions

Conditions

Pigmented Lesions

Outcome Measures

Primary Outcomes (1)

• Degree of improvement in photographs

  photographs

  4 weeks

Study Arms (1)

Treatment Arm

EXPERIMENTAL

Subjects in the treatment arm will receive broadband light treatment

Device: BroadBand Light

Interventions

BroadBand Light DEVICE

Treatment arm will receive Broadband light treatment

Treatment Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy male or female, 18 years or older
• Fitzpatrick skin type I-III
• Has visible signs of moderate to severe skin pigmentation
• Willing to not use any other procedure(s) in the treatment area during the study, such as laser- or light-based treatment, non-light-based device treatment such as radiofrequency or ultrasound, injection of botulinum toxin, collagen, hyaluronic acid filler or other dermal filler, chemical peel, or surgical procedure
• Post-menopausal or surgically sterilized, or using a medically acceptable form of birth control at least 3 months prior to enrollment and during the entire course of the study, and no plans to become pregnant or to father a child for the duration of the study
• Willing to have very limited sun exposure and use an approved sunscreen of SPF 50 or higher on the treatment area every day for the duration of the study, including the follow-up period
• Willing to have digital photographs taken of the treatment area and agree to use of photographs for presentation, educational or marketing purposes
• Subject must agree to not make any changes in their skin regimen for the duration of the study, including the follow-up period
• Subject must be able to read, understand and sign Informed Consent Form
• Must be willing to adhere to the treatment and follow-up schedule and post-treatment care instructions

You may not qualify if:

• Fitzpatrick skin type IV-VI
• Participation in a clinical trial of another device or drug within 6 months prior to enrollment or during the study.
• Any type of prior cosmetic treatment to the target area within 3 months of study participation, such as laser or light-based procedures or surgery.
• Prior injection of botulinum toxin, collagen, hyaluronic acid filler or other dermal filler in the target area within 1 week of study participation.
• History of malignant tumors in the target area.
• Skin abnormalities in the target area, e.g., cuts, scrapes, wounds, scars, large moles.
• Pregnant and/or breastfeeding.
• Having an infection, dermatitis or a rash in the treatment area.
• Significant concurrent illness, such as diabetes mellitus or cardiovascular disease, e.g., uncontrolled hypertension.
• Suffering from coagulation disorders or taking prescription anticoagulation medications.
• History of keloid scarring, hypertrophic scarring or of abnormal wound healing.
• History of immunosuppression/immune deficiency disorders or currently using immunosuppressive medications.
• History of vitiligo, eczema, or psoriasis.
• History of connective tissue disease, such as systemic lupus erythematosus or scleroderma.
• History of seizure disorders due to light.

Sponsors & Collaborators

• Sciton: lead

Study Sites (1)

RefinedMD

Los Gatos, California, 95032, United States

Location

Study Officials

• Swengel, MD

  RefinedMD

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: June 21, 2021
• First Posted: June 23, 2021
• Study Start: May 28, 2021
• Primary Completion: February 25, 2022
• Study Completion: March 15, 2022
• Last Updated: April 19, 2023

Record last verified: 2023-04

Locations

US (1)