PigmentationNCT05750914
Evaluation of Broadband Light Treatment for Pigmented Skin Lesions
A study testing Broadband Light in people with Pigmentation, run by Sciton at 1 site in United States.
Trial summary
Evaluation of safety and efficacy of Broadband light treatment Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pigmentation
- What is being tested?
- Broadband Light
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2022to 19 Jan 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy male or female, 18 years or older
- Fitzpatrick skin type I-IV
- 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 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 30 or higher on the treatment area every day for the duration of the study, including the follow-up period
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- 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
Who cannot join
- 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.
- Skin abnormalities in the target area, e.g., cuts, scrapes, wounds, scars, large moles.
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- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Rochester Dermatologic Surgery
Victor, New York, 14654
About this study
Official title: Evaluation of Inmotion vs Standard Broadband Light Treatment for Pigmented Skin Lesions
Evaluation of safety and efficacy of Broadband light treatment
- Conditions
- Pigmentation
- Being tested
- Broadband Light
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Broadband LightDevice
Broadband Light treatment using standard protocol
| Study group | Role | What they receive |
|---|---|---|
| Treatment Arm | Experimental | Broadband light treatment using in-motion protocol Receives: Device: Broadband Light |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pigmentation
Percent improvement in pigmentation as assessed using digital photographs taken at baseline and 4-6 weeks post treatment
Measured: 4-6 weeks
Skin texture
Percent improvement in skin texture as assessed using digital photographs taken at baseline and 4-6 weeks post treatment
Measured: 4-6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2023
- Study start1 Sep 2022
- Primary completion30 Dec 2023
- Study completion19 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PigmentationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sciton
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sherrif Ibrahim, MD, Principal investigator, Rochester Dermatologic Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05750914
- Sponsor's protocol ID
- SBBLCIP003
- Status last verified
- Apr 2024
- First submitted
- 12 Jan 2023
- Last updated
- 26 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Inmotion vs Standard Broadband Light Treatment for Pigmented Skin Lesions
- ClinicalTrials.gov ID
- NCT05750914
- Acronym / sponsor ID
- SBBLCIP003
- Conditions
- Pigmentation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- ScitonIndustry (pharma, biotech, devices)
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- 30 Dec 2023 (actual)
- Study completion
- 19 Jan 2024 (actual)
- First posted
- 2 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Evaluation of safety and efficacy of Broadband light treatment
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment Arm | Experimental | Device: Broadband LightBroadband light treatment using in-motion protocol |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Healthy male or female, 18 years or older
- Fitzpatrick skin type I-IV
- 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 for the duration of the study. (applicable to female subjects only)
Key exclusion criteria (25 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Broadband LightBroadband Light treatment using standard protocol | Device | Treatment Arm |
Primary outcome
Pigmentation
Time frame: 4-6 weeks
Percent improvement in pigmentation as assessed using digital photographs taken at baseline and 4-6 weeks post treatment
Skin texture
Time frame: 4-6 weeks
Percent improvement in skin texture as assessed using digital photographs taken at baseline and 4-6 weeks post treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sherrif Ibrahim, MD principal investigator
Rochester Dermatologic Surgery
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Broadband Light in people with Pigmentation, run by Sciton at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pigmentation (time frame: 4-6 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Apr 2024.