KeloidNCT03160053
Improving Keloids Using Targeted Ultraviolet-B Irradiation
A study testing NB-UVB in people with Keloid, run by Johns Hopkins University.
Trial summary
Treatment of keloids with targeted Ultraviolet-Beta (UVB) radiation will improve the clinical appearance and induration of lesions. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Keloid
- What is being tested?
- NB-UVB
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- No sites listed yet
- Study dates
- 23 Jun 2015to 15 Jun 2018
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants must be 18 years old or over
- Participants must have a diagnosis of keloid
- No treatment with topical or intralesional steroids for 1 month prior to study
Who cannot join
- Patients who are unable to provide informed consent
- A history of photosensitivity, lupus erythematosus, porphyria or current use of a known photosensitizing drug
- Unwillingness to stop with topical or intralesional steroids for 1 month prior to study
- A history of malignant melanoma
- A history of radiation therapy to area of interest
- Subjects who self-report that they are pregnant or nursing
About this study
Treatment of keloids with targeted Ultraviolet-Beta (UVB) radiation will improve the clinical appearance and induration of lesions.
- Conditions
- Keloid
- Being tested
- NB-UVB
- Medical subject headings
- Keloid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NB-UVBDevice
Also called Narrowband UVB
NB-UVB has an emission spectrum in the ultraviolet B range of 290-320 nm. The system consists of a light source, a spot handpiece, and a light guide that connects the handpiece to the light source. The light source has a Start/Stop switch for light beam activation. Activation can also be controlled remotely with a foot switch. The light source has a timer and an output level control to adjust the intensity of the ultraviolet light. This will be calibrated using a manufacturer-provided UV meter prior to every treatment to ensure accurate doses of ultraviolet light.
| Study group | Role | What they receive |
|---|---|---|
| Treatment Group | Experimental | Keloids that were randomized to the treatment group, were exposed to Narrowband-UVB (NB-UVB). Targeted UVB will be delivered to the keloid for up to 16 weeks using the Lumera UVB light phototherapy device (Daavlin, Bryan Ohio, USA).The affected skin will be irradiated using a hand-held fiber optic cable with an adjustable aperture. Receives: Device: NB-UVB |
| Control Group | No intervention | Keloids that were randomized to a non treatment group, were not exposed to the NB-UVB light. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Appearance As Assessed by the Patient and Observer Scar Assessment (POSAS) Scale
Investigators will evaluate the pre- and post-study clinical photographs of all participants. The grading investigator will grade the degree of improvement using the POSAS scale to measure the clinical appearance of the keloids
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2017
- Study start23 Jun 2015
- Primary completion20 Nov 2015
- Study completion15 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for KeloidStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Each participant served as his/hers own control.
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03160053
- Sponsor's protocol ID
- IRB00055540
- Status last verified
- Jun 2018
- First submitted
- 7 Apr 2017
- Last updated
- 19 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Keloids Using Targeted Ultraviolet-B Irradiation
- ClinicalTrials.gov ID
- NCT03160053
- Acronym / sponsor ID
- IRB00055540
- Conditions
- Keloid
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Study start
- 23 Jun 2015 (actual)
- Primary completion
- 20 Nov 2015 (actual)
- Study completion
- 15 Jun 2018 (actual)
- First posted
- 19 May 2017 (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.
Treatment of keloids with targeted Ultraviolet-Beta (UVB) radiation will improve the clinical appearance and induration of lesions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Each participant served as his/hers own control.
| Arm | Type | Receives |
|---|---|---|
| Treatment Group | Experimental | Device: NB-UVBKeloids that were randomized to the treatment group, were exposed to Narrowband-UVB (NB-UVB). Targeted UVB will be delivered to the keloid for up to 16 weeks using the Lumera UVB light phototherapy device (Daavlin, Bryan Ohio, USA).The affected skin will be irradiated using a hand-held fiber optic cable with an adjustable aperture. |
| Control Group | No intervention | –Keloids that were randomized to a non treatment group, were not exposed to the NB-UVB light. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Participants must be 18 years old or over
- Participants must have a diagnosis of keloid
- No treatment with topical or intralesional steroids for 1 month prior to study
Key exclusion criteria (6 listed)
- Patients who are unable to provide informed consent
- A history of photosensitivity, lupus erythematosus, porphyria or current use of a known photosensitizing drug
- Unwillingness to stop with topical or intralesional steroids for 1 month prior to study
- A history of malignant melanoma
- A history of radiation therapy to area of interest
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 |
|---|---|---|
| NB-UVBAlso: Narrowband UVBNB-UVB has an emission spectrum in the ultraviolet B range of 290-320 nm. The system consists of a light source, a spot handpiece, and a light guide that connects the handpiece to the light source. The light source has a Start/Stop switch for light beam activation. Activation can also be controlled remotely with a foot switch. The light source has a timer and an output level control to adjust the intensity of the ultraviolet light. This will be calibrated using a manufacturer-provided UV meter prior to every treatment to ensure accurate doses of ultraviolet light. | Device | Treatment Group |
Primary outcome
Clinical Appearance As Assessed by the Patient and Observer Scar Assessment (POSAS) Scale
Time frame: 16 weeks
Investigators will evaluate the pre- and post-study clinical photographs of all participants. The grading investigator will grade the degree of improvement using the POSAS scale to measure the clinical appearance of the keloids
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 19 Jun 2018.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing NB-UVB in people with Keloid, run by Johns Hopkins University.
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 3 inclusion and 6 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 19 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
Clinical Appearance As Assessed by the Patient and Observer Scar Assessment (POSAS) Scale (time frame: 16 weeks). 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 19 Jun 2018.