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

Sciton

Status

Completed

Conditions

Pigmented Lesions

Treatments

Device: BroadBand Light

Study type

Interventional

Funder types

Industry

Identifiers

NCT04936919

BBLCIP002

Details and patient eligibility

About

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

Full description

This study is conducted to investigate the effects of intense pulsed broadband light device for treatment of pigmented lesions

Enrollment

12 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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.
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).
Current smoker or history of smoking within 6 months of study participation.