Evaluation of Broadband Light Treatment for Pigmented Skin Lesions

NCT05750914 | Completed FDA Device

• 1 other identifier: SBBLCIP003
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

Evaluation of safety and efficacy of Broadband light treatment

Conditions

Pigmentation

Outcome Measures

Primary Outcomes (2)

• Pigmentation

  Percent improvement in pigmentation as assessed using digital photographs taken at baseline and 4-6 weeks post treatment

  4-6 weeks

• Skin texture

  Percent improvement in skin texture as assessed using digital photographs taken at baseline and 4-6 weeks post treatment

  4-6 weeks

Study Arms (1)

Treatment Arm

EXPERIMENTAL

Broadband light treatment using in-motion protocol

Device: Broadband Light

Interventions

Broadband Light DEVICE

Broadband Light treatment using standard protocol

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-IV
• 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 for the duration of the study. (applicable to female subjects only)
• Willing to have very limited sun exposure and use an approved sunscreen of SPF 30 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 V-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 (applicable to female subjects only)
• 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)

Rochester Dermatologic Surgery

Victor, New York, 14654, United States

Location

Study Officials

• Sherrif Ibrahim, MD

  Rochester Dermatologic Surgery

  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: January 12, 2023
• First Posted: March 2, 2023
• Study Start: September 1, 2022
• Primary Completion: December 30, 2023
• Study Completion: January 19, 2024
• Last Updated: April 26, 2024

Record last verified: 2024-04

Locations

US (1)