ClinicalTrials.gg
CompletedNCT04936919Updated Apr 19, 2023

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

An interventional study of BroadBand Light in Pigmented Lesions, 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 2023-04-19.

Sponsored by Sciton · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was Feb 2022, 4 years 8 months ago, and no results have been posted to the registry.
Phase
Not applicable
Study type
Interventional
Enrollment
12
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

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

Read the detailed description

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

02

Conditions studied

  • Pigmented Lesions
03

In context

Lead sponsor

Sciton is the lead sponsor of 15 studies on the registry; 2 are open to participants now.

Of its 11 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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
  • or surgically sterilized, or using a medically acceptable form of 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 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 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 /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 , 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.
Terms in these criteria, in plain language(5)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Postmenopausal

Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

05

Study design

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

Study arms

  • Experimental
    Treatment Arm

    Subjects in the treatment arm will receive broadband light treatment

    Device: BroadBand Light

Interventions

  • DeviceBroadBand Light

    Treatment arm will receive Broadband light treatment

06

What researchers measure

Primary outcomes

  1. Degree of improvement in photographs

    photographs

    Time frame: 4 weeks

07

Study locations

1 site
  • RefinedMD
    Los Gatos, California 95032, United States
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 19, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04936919
Lead sponsor
Sciton
Responsible party
Sponsor
First posted
Jun 23, 2021
Start date
May 28, 2021
Primary completion
Feb 25, 2022
Completion
Mar 15, 2022
Last update
Apr 19, 2023

Study contacts

Swengel, MD
principal investigator · RefinedMD

Oversight

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

Not currently enrolling

This study is completed, as verified in Apr 2023. You cannot join it, but the record below documents what was studied.

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