Evaluation of Broadband Light Treatment for Solar Lentigines

NCT06363240 | Completed FDA Device

• 1 other identifier: CBBLCIP001
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

Brief Summary

Broadband light treatment for Solar Lentigines

Conditions

Solar Lentigo

Outcome Measures

Primary Outcomes (1)

• Changes in skin post treatment

  Histological changes post treatment

  10 minutes - 1 month post treatment

Study Arms (1)

Treatment Arm

EXPERIMENTAL

Each subject will receive Broadband light treatment

Device: Broadband Light

Interventions

Broadband Light DEVICE

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-IV Has visible signs of moderate to severe skin pigmentation Willing to have multiple biopsies taken from treatment location at various time points Willing to not use any other procedure(s) in the treatment area during the study, such as laser 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 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 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. 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. Any use of medication that is known to increase sensitivity to light according to Investigator's discretion.
• 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.
• History of radiation to the treatment area or undergoing systemic chemotherapy for the treatment of cancer.
• History of pigmentary disorders, particularly tendency for hyper- or hypo-pigmentation.
• Systemic use of retinoid, such as isotretinoin, or corticosteroid, as applicable, within 6 months of study participation.
• Topical use of retinoid, such as isotretinoin, corticosteroid or hydroquinone on the target area within 1 month of participation.
• Anytime in life, having have used gold therapy (gold salts) for disorders such as rheumatologic disease or lupus.
• 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).

Sponsors & Collaborators

• Sciton: lead

Study Sites (1)

Sanctuary Plastic Surgery

Boca Raton, Florida, 33431, United States

Location

Study Officials

• Jonathan Cook, MD

  Sanctuary Plastic 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: April 9, 2024
• First Posted: April 12, 2024
• Study Start: March 12, 2024
• Primary Completion: December 20, 2024
• Study Completion: April 30, 2025
• Last Updated: May 16, 2025

Record last verified: 2025-05

Locations

US (1)