Grover's DiseaseNCT04343586
Blue Light Phototherapy
A study testing Blue light phototherapy in people with Grover's Disease and Psoriasis Vulgaris, run by Northwestern University at 1 site in United States.
Trial summary
This study will use Blue-light Photo-therapy to treat patients with psoriasis vulgaris and Grover's Disease. Read more about this study
- Who is it for?
- Ages 18 to 89 years
- Conditions the study is for
- Grover's Disease, Psoriasis Vulgaris
- What is being tested?
- Blue light phototherapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2020to 22 Sep 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient's aged 18-89 at time of enrollment
- Previous diagnosis of psoriasis vulgaris or Grover's disease
Who cannot join
- All Groups: Subjects who are younger than 18 years of age or older than 90 years of age
- Patients who have received topical or systemic treatment within the prior 2 weeks of planned phototherapy
- Patients prescribed any of the following drugs for issues not related to their psoriasis or Grover's disease
- topical steroids
- calcineurin inhibitors
- methotrexate
Show all 10Show fewer
- retinoids
- biologic agents
- Unable to schedule phototherapy sessions
- We will not recruit the following populations: adults unable to consent, individuals who are not yet adults (infants, children, teenagers), pregnant women, prisoners and other vulnerable populations.
Trial locations and contacts
1 site in 1 country.
United States1 site
Northwestern University Department of Dermatology
Chicago, Illinois, 60611
About this study
Official title: Development & Preliminary Clinical Validation Blue Light Phototherapy Systems for T-Cell
This study will use Blue-light Photo-therapy to treat patients with psoriasis vulgaris and Grover's Disease.
- Conditions
- Grover's Disease, Psoriasis Vulgaris
- Being tested
- Blue light phototherapy
- Medical subject headings
- Grover's disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blue light phototherapyDevice
Also called DusaPharma Blu-U model 4170
Phototherapy- Wavelength: 417±15 nm
| Study group | Role | What they receive |
|---|---|---|
| Adult treatment arm | Experimental | Adults enrolled in the study will receive treatment (blue light phototherapy) on one area of their body affected by psoriasis or Grover's disease. The treatment area (restricted by size of the device) will be compared to untreated areas affected by disease on the same patient. Receives: Device: Blue light phototherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy of Blue Light Therapy for Patients With Grover's Disease
Demonstrate preliminary skin efficacy as measured by lesion count
Measured: Time Frame: 5 weeks
Assess User Experience With the Dermatology Life Quality Index (DLQI) Pre and Post-treatment.
The DLQI is a questionnaire with 10 questions. The maximum score is 30 and minimum is 0. The higher the score, the more quality of life is impaired.
Measured: Time Frame: 5 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2020
- Study start1 Sep 2020
- Primary completion20 Dec 2021
- Study completion22 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Grover's DiseaseStudies of the same condition, open and under way.
- More trials run by Northwestern 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Collaborators
- T-Cellerate LLC
- Responsible party
- Principal investigator, Shuai (Steve) Xu, Northwestern University
- Investigators
- Shuai Xu, Principal investigator, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04343586
- Sponsor's protocol ID
- STU00210472
- Status last verified
- Feb 2023
- First submitted
- 24 Jan 2020
- Last updated
- 17 Mar 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Publications
Olagbenro M, Ravi S, Myers D, Lin D, Woodburn W, Walter JR, Xu S. Assessment of Blue Light Phototherapy for Grover Disease: A Nonrandomized Controlled Trial. JAMA Dermatol. 2023 Jan 1;159(1):102-104. doi: 10.1001/jamadermatol.2022.4491.
PubMed 36449285
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development & Preliminary Clinical Validation Blue Light Phototherapy Systems for T-Cell
- ClinicalTrials.gov ID
- NCT04343586
- Acronym / sponsor ID
- STU00210472
- Conditions
- Grover's Disease, Psoriasis Vulgaris
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Collaborators
- T-Cellerate LLC
- Study start
- 1 Sep 2020 (actual)
- Primary completion
- 20 Dec 2021 (actual)
- Study completion
- 22 Sep 2022 (actual)
- First posted
- 13 Apr 2020 (actual)
- Results
- Posted 17 Mar 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will use Blue-light Photo-therapy to treat patients with psoriasis vulgaris and Grover's Disease.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adult treatment arm | Experimental | Device: Blue light phototherapyAdults enrolled in the study will receive treatment (blue light phototherapy) on one area of their body affected by psoriasis or Grover's disease. The treatment area (restricted by size of the device) will be compared to untreated areas affected by disease on the same patient. |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patient's aged 18-89 at time of enrollment
- Previous diagnosis of psoriasis vulgaris or Grover's disease
Key exclusion criteria (10 listed)
- All Groups: Subjects who are younger than 18 years of age or older than 90 years of age
- Patients who have received topical or systemic treatment within the prior 2 weeks of planned phototherapy
- Patients prescribed any of the following drugs for issues not related to their psoriasis or Grover's disease
- Unable to schedule phototherapy sessions
- We will not recruit the following populations: adults unable to consent, individuals who are not yet adults (infants, children, teenagers), pregnant women, prisoners and other vulnerable populations.
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 |
|---|---|---|
| Blue light phototherapyAlso: DusaPharma Blu-U model 4170Phototherapy- Wavelength: 417±15 nm | Device | Adult treatment arm |
Primary outcome
Efficacy of Blue Light Therapy for Patients With Grover's Disease
Time frame: Time Frame: 5 weeks
Demonstrate preliminary skin efficacy as measured by lesion count
Assess User Experience With the Dermatology Life Quality Index (DLQI) Pre and Post-treatment.
Time frame: Time Frame: 5 weeks
The DLQI is a questionnaire with 10 questions. The maximum score is 30 and minimum is 0. The higher the score, the more quality of life is impaired.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 36449285Olagbenro M, Ravi S, Myers D, Lin D, Woodburn W, Walter JR, Xu S. Assessment of Blue Light Phototherapy for Grover Disease: A Nonrandomized Controlled Trial. JAMA Dermatol. 2023 Jan 1;159(1):102-104. doi: 10.1001/jamadermatol.2022.4491.
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.
Shuai Xu principal investigator
Northwestern University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blue light phototherapy in people with Grover's Disease and Psoriasis Vulgaris, run by Northwestern University 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 2 inclusion and 10 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 17 Mar 2023. 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?
Yes. Results are posted in the registry (first posted 17 Mar 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Efficacy of Blue Light Therapy for Patients With Grover's Disease (time frame: Time Frame: 5 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?
On the ClinicalTrials.gov record for NCT04343586, which also lists 1 linked publication.
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 17 Mar 2023.