Safety and Efficacy of Broad Band Light In Motion Treatment

NCT03970317 | Completed FDA Device

• 1 other identifier: BBLCIP001
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

Brief Summary

Evaluate safety and efficacy of Broad Band Light (BBL) motion technique treatment for pigmentation, skin tone and texture

Conditions

Pigmentation

Outcome Measures

Primary Outcomes (1)

• Photographs

  Evaluation of Photographs using Physician's Global Assessment Scale (0-4) where 0 is no change and 4 is very significant improvement

  6 weeks

Study Arms (1)

Broad Band Light

EXPERIMENTAL

Broad Band Light (BBL) motion treatment

Device: Broad Band Light

Interventions

Broad Band Light DEVICE

Broad Band Light Device

Also known as: BBL

Broad Band Light

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-V
• Has visible signs of moderate to severe skin pigmentation
• 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
• Willing to have digital photographs taken of the treatment area and agree to use of photographs for presentation, educational or marketing purposes
• 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
• Must be willing to adhere to the treatment and follow-up schedule and post-treatment care instructions
• Agree 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

You may not qualify if:

• 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.
• Any use of medication that is known to increase sensitivity to light according to Investigator's discretion.

Sponsors & Collaborators

• Sciton: lead

Study Sites (1)

Refined Dermatology

Los Gatos, California, 95032, United States

Location

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: May 29, 2019
• First Posted: May 31, 2019
• Study Start: April 12, 2019
• Primary Completion: August 30, 2020
• Study Completion: September 29, 2020
• Last Updated: October 20, 2020

Record last verified: 2020-10

Locations

US (1)