Evaluation of Broadband Light Treatment Protocol for Pigmented Skin Lesions - A Comparative Study

Evaluation of Broadband Light Treatment Protocols for Pigmented Skin Lesions - A Comparation Study

Evaluation of Broadband Light Treatment Protocols for Pigmented Skin Lesions - A comparative study

Study Overview

• Status: Completed
• Conditions: Pigmentation
• Intervention / Treatment: Device: Broadband Light

• Study Type: Interventional
• Enrollment (Actual): 3
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New Jersey
    • Montclair, New Jersey, United States, 07042
      • New Jersey Plastic Surgery

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. Healthy male or female, 18 years or older
2. Fitzpatrick skin type I-IV
3. Has visible signs of moderate to severe skin pigmentation
4. 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
5. 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)
6. 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
7. Willing to have digital photographs taken of the treatment area and agree to use of photographs for presentation, educational or marketing purposes
8. Subject must agree to not make any changes in their skin regimen for the duration of the study, including the follow-up period
9. Subject must be able to read, understand and sign Informed Consent Form
10. Must be willing to adhere to the treatment and follow-up schedule and post-treatment care instructions

Exclusion Criteria:

1. Fitzpatrick skin type V-VI
2. Participation in a clinical trial of another device or drug within 6 months prior to enrollment or during the study.
3. 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.
4. Prior injection of botulinum toxin, collagen, hyaluronic acid filler or other dermal filler in the target area within 1 week of study participation.
5. History of malignant tumors in the target area.
6. Skin abnormalities in the target area, e.g., cuts, scrapes, wounds, scars, large moles.
7. Pregnant and/or breastfeeding (applicable to female subjects only)
8. Having an infection, dermatitis or a rash in the treatment area.
9. Significant concurrent illness, such as diabetes mellitus or cardiovascular disease, e.g., uncontrolled hypertension.
10. Suffering from coagulation disorders or taking prescription anticoagulation medications.
11. History of keloid scarring, hypertrophic scarring or of abnormal wound healing.
12. History of immunosuppression/immune deficiency disorders or currently using immunosuppressive medications.
13. History of vitiligo, eczema, or psoriasis.
14. History of connective tissue disease, such as systemic lupus erythematosus or scleroderma.
15. History of seizure disorders due to light.
16. Any use of medication that is known to increase sensitivity to light according to Investigator's discretion.
17. History of disease stimulated by heat, such as recurrent herpes simplex and/or herpes zoster (shingles) in the treatment area, unless treatment is conducted following a prophylactic regimen.
18. History of radiation to the treatment area or undergoing systemic chemotherapy for the treatment of cancer.
19. History of pigmentary disorders, particularly tendency for hyper- or hypo-pigmentation.
20. Systemic use of retinoid, such as isotretinoin, or corticosteroid, as applicable, within 6 months of study participation.
21. Topical use of retinoid, such as isotretinoin, corticosteroid or hydroquinone on the target area within 1 month of participation.
22. Anytime in life, having have used gold therapy (gold salts) for disorders such as rheumatologic disease or lupus.
23. Excessively tanned in areas to be treated, or unable/unlikely to refrain from tanning during the study (for example, subject's occupation requires regular sun exposure).
24. Current smoker or history of smoking within 6 months of study participation.
25. As per the Investigator's discretion, any physical or mental condition which might make it unsafe for the subject to participate in this study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment Arm; Broadband light treatment will be provided on pigmented skin lesions	Device: Broadband Light; Broadband Light device will be used for treatment of pigmented skin lesions

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in pigmentation, skin tone and texture	Change in pigmentation, skin tone and texture will be evaluated using photographs captured at baseline and 4-6 weeks post treatment	4-6 weeks

Collaborators and Investigators

• Sponsor: Sciton

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2022
• Primary Completion (Actual): May 30, 2023
• Study Completion (Actual): June 6, 2023

Study Registration Dates

• First Submitted: December 6, 2022
• First Submitted That Met QC Criteria: December 14, 2022
• First Posted (Actual): December 22, 2022

Study Record Updates

• Last Update Posted (Estimated): December 1, 2023
• Last Update Submitted That Met QC Criteria: November 29, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Skin Diseases; Pigmentation Disorders
• Other Study ID Numbers: SBBLCIP004

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes