PsoriasisNCT02447068
Luma Light System Proof of Concept Study in Subjects With Mild to Moderate Psoriasis
A study testing Luma Light System, Luma Light and Occlusive Dressing in people with Psoriasis, run by Illumicure Inc at 1 site in United States.
Trial summary
This is a proof of concept, investigator blinded study to evaluate the efficacy and safety of a novel combination of a home narrow band ultraviolet B (NBUVB) lamp with an occlusive dressing in adult subjects with mild to moderate psoriasis vulgaris. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Psoriasis
- What is being tested?
- Luma Light System, Luma Light and Occlusive Dressing
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- May 2015to Sep 2015
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female of any race, 18 to 65 (inclusive) years of age.
- Verbal and written informed consent obtained from the subject.
- Has a clinical diagnosis of mild to moderate psoriasis at the Screening and Baseline visits.
- Has an IGA score of 2 or 3.
- Target plaque assessment (TPA) score between 6-9 and a score of at least 2 for each of the 3 different psoriasis signs and symptoms (erythema, plaque elevation, and scaling)
- Has at least 4 plaques of at least 10 cm2 with TPA scores not differing from each other by a score of more than 1
Show all 11Show fewer
- Is in good general health as determined by the Investigator based on the subject's medical history, vital signs and physical examination.
- Females of childbearing potential must have negative urine pregnancy test results.
- Females of childbearing potential agree to use acceptable methods of contraception from the screening visit continuously until 30 days after end of treatment.
- Subject agrees to use only the Sponsor provided cleanser and lotion during the study period.
- Subject is willing and able to return for all study visits.
Who cannot join
- Presence of psoriasis that was previously treated with prescription medications prior to the Screening visit and was non-responsive to treatment, as determined by the Investigator.
- Presence of any concurrent skin condition that could interfere with the evaluation of the study device, as determined by the Investigator.
- Female who is pregnant, nursing an infant, or planning a pregnancy during the study period.
- Treatment with any investigational drug or device within 30 days or 5 half-lives (whichever is longer) prior to the Baseline visit, or concurrent participation in another clinical trial with an investigational drug or device.
- History of melanoma.
- Subject has any medical, social or psychological conditions that, in the opinion of the Investigator, preclude them from receiving the pre-treatment, required treatment, and post-treatment procedures and evaluations.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Redwood Family Dermatology
Santa Rosa, California, 95403
Liza Marie, 707-755-3946, liza@redwoodfamilyderm.com
Jeffrey Sugarman, MD, PhD
About this study
Official title: A Proof of Concept, Investigator Blinded Study to Evaluate the Efficacy and Safety of a Novel Combination of a Home Narrow Band Ultraviolet B (NBUVB) Lamp With an Occlusive Dressing in Adult Subjects With Mild to Moderate Psoriasis Vulgaris
This is a proof of concept, investigator blinded study to evaluate the efficacy and safety of a novel combination of a home narrow band ultraviolet B (NBUVB) lamp with an occlusive dressing in adult subjects with mild to moderate psoriasis vulgaris. Four interpatient arms will be used to compare the efficacy of combination of NBUVB with an occlusive dressing to the light alone and to dressing alone and no treatment. Ten patients will be enrolled in this 6 weeks study.
- Conditions
- Psoriasis
- Being tested
- Luma Light System, Luma Light, Occlusive Dressing
- Medical subject headings
- Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Luma Light SystemDevice
The Luma Light System combines a NBUVB light with an occlusive dressing.
Luma LightDevice
NBUVB light
Occlusive DressingDevice
Off-the-shelf occlusive dressing
| Study group | Role | What they receive |
|---|---|---|
| Non-treatment Control | No intervention | Control arm will not have any intervention |
| Occlusive Dressing | Active comparator | An off-the-shelf dressing occlusive dressing will be used as an active comparator. Receives: Device: Occlusive Dressing |
| Luma Light | Active comparator | A NBUVB light will be used as an active comparator. Receives: Device: Luma Light |
| Luma Light System | Experimental | The experimental arm will be a combination of an occlusive dressing and NBUVB light. Receives: Device: Luma Light System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Target Plaque Assessment
Local efficacy will be evaluated with a 0-4 point scale for three signs and symptoms of psoriasis: erythema, plaque elevation, and scaling.
Measured: 6 weeks
Local Skin Reactions
Tolerability will be evaluated through assessment of selected local signs and symptoms at the article-application site: Burning/stinging, pain and pruritus. Each sign or symptom will be graded at Baseline and each subsequent visit using a 0-3 scale (0 = none, 1 = mild, 2 = moderate, or 3 = severe).
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2015 (estimated)
- Study startMay 2015
- Primary completionSep 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PsoriasisStudies 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
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Illumicure Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02447068
- Sponsor's protocol ID
- L-001
- Status last verified
- May 2015
- First submitted
- 14 May 2015
- Last updated
- 20 May 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Proof of Concept, Investigator Blinded Study to Evaluate the Efficacy and Safety of a Novel Combination of a Home Narrow Band Ultraviolet B (NBUVB) Lamp With an Occlusive Dressing in Adult Subjects With Mild to Moderate Psoriasis Vulgaris
- ClinicalTrials.gov ID
- NCT02447068
- Acronym / sponsor ID
- L-001
- Conditions
- Psoriasis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Illumicure IncIndustry (pharma, biotech, devices)
- Study start
- May 2015
- Primary completion
- Sep 2015 (estimated)
- First posted
- 18 May 2015 (estimated)
- 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.
This is a proof of concept, investigator blinded study to evaluate the efficacy and safety of a novel combination of a home narrow band ultraviolet B (NBUVB) lamp with an occlusive dressing in adult subjects with mild to moderate psoriasis vulgaris. Four interpatient arms will be used to compare the efficacy of combination of NBUVB with an occlusive dressing to the light alone and to dressing alone and no treatment. Ten patients will be enrolled in this 6 weeks study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Non-treatment Control | No intervention | –Control arm will not have any intervention |
| Occlusive Dressing | Active comparator | Device: Occlusive DressingAn off-the-shelf dressing occlusive dressing will be used as an active comparator. |
| Luma Light | Active comparator | Device: Luma LightA NBUVB light will be used as an active comparator. |
| Luma Light System | Experimental | Device: Luma Light SystemThe experimental arm will be a combination of an occlusive dressing and NBUVB light. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Male or female of any race, 18 to 65 (inclusive) years of age.
- Verbal and written informed consent obtained from the subject.
- Has a clinical diagnosis of mild to moderate psoriasis at the Screening and Baseline visits.
- Has an IGA score of 2 or 3.
- Target plaque assessment (TPA) score between 6-9 and a score of at least 2 for each of the 3 different psoriasis signs and symptoms (erythema, plaque elevation, and scaling)
Key exclusion criteria (6 listed)
- Presence of psoriasis that was previously treated with prescription medications prior to the Screening visit and was non-responsive to treatment, as determined by the Investigator.
- Presence of any concurrent skin condition that could interfere with the evaluation of the study device, as determined by the Investigator.
- Female who is pregnant, nursing an infant, or planning a pregnancy during the study period.
- Treatment with any investigational drug or device within 30 days or 5 half-lives (whichever is longer) prior to the Baseline visit, or concurrent participation in another clinical trial with an investigational drug or device.
- History of melanoma.
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 |
|---|---|---|
| Luma Light SystemThe Luma Light System combines a NBUVB light with an occlusive dressing. | Device | Luma Light System |
| Luma LightNBUVB light | Device | Luma Light |
| Occlusive DressingOff-the-shelf occlusive dressing | Device | Occlusive Dressing |
Primary outcome
Target Plaque Assessment
Time frame: 6 weeks
Local efficacy will be evaluated with a 0-4 point scale for three signs and symptoms of psoriasis: erythema, plaque elevation, and scaling.
Local Skin Reactions
Time frame: 6 weeks
Tolerability will be evaluated through assessment of selected local signs and symptoms at the article-application site: Burning/stinging, pain and pruritus. Each sign or symptom will be graded at Baseline and each subsequent visit using a 0-3 scale (0 = none, 1 = mild, 2 = moderate, or 3 = severe).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2015.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Luma Light System, Luma Light and Occlusive Dressing in people with Psoriasis, run by Illumicure Inc 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 11 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: status not confirmed, as of the sponsor's last update on 20 May 2015. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Liza Marie (707-755-3946, liza@redwoodfamilyderm.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Target Plaque Assessment (time frame: 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 20 May 2015.