CClinicalTrials.gg
CompletedNCT06363240Updated May 16, 2025

Evaluation of Broadband Light Treatment for Solar Lentigines

An interventional study of Broadband Light in Solar Lentigo, sponsored by Sciton. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-05-16.

Sponsored by Sciton · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
4
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

Broadband light treatment for Solar Lentigines

02

Conditions studied

  • Solar Lentigo

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03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

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).

Current smoker or history of smoking within 6 months of study participation. As per the Investigator's discretion, any physical or mental condition which might make it unsafe for the subject to participate in this study

04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
4 participants (actual)

Study arms

  • Experimental
    Treatment Arm

    Each subject will receive Broadband light treatment

    Device: Broadband Light

Interventions

  • DeviceBroadband Light

    Broadband Light treatment

05

What researchers measure

Primary outcomes

  1. Changes in skin post treatment

    Histological changes post treatment

    Time frame: 10 minutes - 1 month post treatment

06

Study locations

1 site
  • Sanctuary Plastic Surgery
    Boca Raton, Florida 33431, United States
07

Registry details

Key details

Study ID
NCT06363240
Lead sponsor
Sciton
Responsible party
Sponsor
First posted
Apr 12, 2024
Start date
Mar 12, 2024
Primary completion
Dec 20, 2024
Completion
Apr 30, 2025
Last update
May 16, 2025

Study contacts

Jonathan Cook, MD
principal investigator · Sanctuary Plastic Surgery

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in May 2025. You cannot join it, but the record below documents what was studied.

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