Healthy Participants and/or PatientsNCT03049319
MED in UVB Devices in the Presence and Absence of UV Filter
A study testing Psoriashield in the presence of a non-UV absorbing block., Psoriashield in the presence of a UV absorbing block. and Psoriashield in people with Healthy Participants and/or Patients, run by Wake Forest University Health Sciences at 1 site in United States.
Trial summary
Psoriasis affects 2-3% of the American population. While a wide variety of therapies currently exist, including topical corticosteroids and Vit D analogs, oral immunosuppressant and retinoid agents a better understanding of phototherapy is needed. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy Participants and/or Patients
- What is being tested?
- Psoriashield in the presence of a non-UV absorbing block., Psoriashield in the presence of a UV absorbing block. and Psoriashield
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2017to 17 Jan 2019
- 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
- Male and female subjects older than 18 years of age.
- Good health as determined by lack of clinically significant abnormalities in medical history and clinical assessment, as judged by the Investigator.
- Subject is capable of understanding and willing to provide a signed and dated written voluntary informed consent before any protocol specific procedures are performed.
- The subject is able to complete the study and comply with study instructions, including attending all study visits.
- If a female subject of childbearing potential, subject has a negative urine pregnancy test.
Who cannot join
- Subject has a history of being non-responsive to UVB therapy
- Subject received phototherapy in the past four weeks
- Subject used topical therapy within two weeks from baseline (Excluding emollients)
- Subject has used experimental drugs or devices at least one month prior to Baseline
- Subject has a known history of Photosensitivity disorder (Including Xeroderma pigmentosum, SLE, Cockayne Syndrome, Bloom Syndrome) or is currently taking any medication that causes photosensitivity that requires they avoid sunlight.
- Subject has other serious skin disorder or any chronic medical condition that is not well controlled.
Show all 11Show fewer
- Subject has major illness within 30 days prior to the Baseline visit.
- Subject has history of any immunocompromising disease.
- Subject is pregnant or nursing. Pregnant and nursing females will not be allowed in the study, and females of childbearing potential will have a pregnancy test at Baseline.
- Subject has a skin condition or disease that may require concurrent therapy or may confound the evaluation.
- Presence of any skin condition or coloration that would interfere with placement of test sites or the response or assessment of MED.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparing Minimal Erythema Dose (MED) in UVB Devices in the Presence and Absence of UV Filter
Psoriasis affects 2-3% of the American population. While a wide variety of therapies currently exist, including topical corticosteroids and Vit D analogs, oral immunosuppressant and retinoid agents a better understanding of phototherapy is needed. Given the prevalence of localized psoriasis and dissatisfaction with treatment, investigation of localized treatment should be a priority for researchers with goals to improve the current standard of care.
Read the detailed description
Psoriasis affects 2-3% of the American population. Psoriasis involving less than 10% BSA in the absence of joint involvement tends to be treated locally. More than 80% of people with psoriasis have <10% BSA involvement. A wide variety of therapies currently exist, including topical corticosteroids and Vit D analogs, oral immunosuppressant, retinoid agents, and phototherapy. Given the prevalence of localized psoriasis and dissatisfaction with treatment, investigation of localized treatment should be a priority for researchers with goals to improve the current standard of care.
UV light has a wavelength of 10nm - 380nm, which is slightly shorter than the wavelength of visible light. The UV light can be further classified to a narrow spectrum (UVB light has a wavelength of 280-315 nm). UVA has a wavelength of 315-400nm. Tanning beds use UV light to produce their effects. Whole body ultraviolet B (UVB) phototherapy is efficacious and is recommended as a first line option in selective psoriasis treatment recommendations. In pregnancy, UVB therapy is recommended as first line treatment for extensive plaque and guttate psoriasis.
Although UVB phototherapy has been included in the guidelines for psoriasis treatment, its use does not come without risk. Toxicities include cataract formation, herpes reactivation, photoaging, and with long-term exposure may lead to an increased risk of genital tumors in males. In addition, the use of UVB is rarely used as a first-line treatment for localized psoriasis probably due to financial issues and increased requirements for clinic visits. Narrowband UVB therapy (emission 311- 313nm) is superior to broad-band UVB light, and reduces toxicity. Psoriatic plaques can withstand much higher doses of UV light than the surrounding uninvolved skin; UV treatment of just the involved skin therefore offers increased efficacy in fewer treatments. In addition, localized treatment may remain in remission even 4 months after clearing with localized laser treatment. Localized treatment should therefore be a more favorable treatment option for psoriasis, using higher doses with sparing of healthy skin.
- Conditions
- Healthy Participants and/or Patients
- Being tested
- Psoriashield in the presence of a non-UV absorbing block., Psoriashield in the presence of a UV absorbing block., Psoriashield, Xtrac laser in the presence of a non-UV absorbing block., Xtrac in the presence of a UV absorbing block.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Psoriashield in the presence of a non-UV absorbing block.Device
The psoriashield will be applied to patient's back in the presence of a non-UV absorbing block.
Psoriashield in the presence of a UV absorbing block.Device
The psoriashield will be applied to patient's back in the presence of a UV absorbing block.
PsoriashieldDevice
The psoriashield will be applied to patient's back.
Xtrac laser in the presence of a non-UV absorbing block.Device
The Xtrac laser will be applied to patient's back in the presence of a UV absorbing block.
Xtrac in the presence of a UV absorbing block.Device
The Xtrac laser will be applied to patient's back in the presence of a non-UV absorbing block.
Xtrac laserDevice
The Xtrac laser will be applied to patient's back.
| Study group | Role | What they receive |
|---|---|---|
| Laser | Experimental | All six interventions will be applied to patient's back. Receives: Device: Psoriashield in the presence of a non-UV absorbing block.; Device: Psoriashield in the presence of a UV absorbing block.; Device: Psoriashield; Device: Xtrac laser in the presence of a non-UV absorbing block.; Device: Xtrac in the presence of a UV absorbing block.; Device: Xtrac laser |
What is being measured
The primary outcome is the main question the study is designed to answer.
MED Reading
Minimal Erythemal Dose
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2017
- Study start1 Feb 2017
- Primary completion17 Jan 2019
- Study completion17 Jan 2019
Why it stopped: The sponsor did not provide the equipment needed to do study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Healthy Participants and/or PatientsStudies of the same condition, open and under way.
- More trials run by Wake Forest University Health SciencesThe 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
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Steven R Feldman, MD PhD, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03049319
- Sponsor's protocol ID
- IRB00042226
- Status last verified
- Aug 2019
- First submitted
- 7 Feb 2017
- Last updated
- 29 Aug 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Publications
Feldman SR, Mellen BG, Housman TS, Fitzpatrick RE, Geronemus RG, Friedman PM, Vasily DB, Morison WL. Efficacy of the 308-nm excimer laser for treatment of psoriasis: results of a multicenter study. J Am Acad Dermatol. 2002 Jun;46(6):900-6. doi: 10.1067/mjd.2002.120454.
PubMed 12063488Walters IB, Burack LH, Coven TR, Gilleaudeau P, Krueger JG. Suberythemogenic narrow-band UVB is markedly more effective than conventional UVB in treatment of psoriasis vulgaris. J Am Acad Dermatol. 1999 Jun;40(6 Pt 1):893-900. doi: 10.1016/s0190-9622(99)70076-9.
PubMed 10365919
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing Minimal Erythema Dose (MED) in UVB Devices in the Presence and Absence of UV Filter
- ClinicalTrials.gov ID
- NCT03049319
- Acronym / sponsor ID
- IRB00042226
- Conditions
- Healthy Participants and/or Patients
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The sponsor did not provide the equipment needed to do study.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Study start
- 1 Feb 2017 (actual)
- Primary completion
- 17 Jan 2019 (actual)
- Study completion
- 17 Jan 2019 (actual)
- First posted
- 10 Feb 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.
Psoriasis affects 2-3% of the American population. While a wide variety of therapies currently exist, including topical corticosteroids and Vit D analogs, oral immunosuppressant and retinoid agents a better understanding of phototherapy is needed. Given the prevalence of localized psoriasis and dissatisfaction with treatment, investigation of localized treatment should be a priority for researchers with goals to improve the current standard of care.
Detailed description
Psoriasis affects 2-3% of the American population. Psoriasis involving less than 10% BSA in the absence of joint involvement tends to be treated locally. More than 80% of people with psoriasis have <10% BSA involvement. A wide variety of therapies currently exist, including topical corticosteroids and Vit D analogs, oral immunosuppressant, retinoid agents, and phototherapy. Given the prevalence of localized psoriasis and dissatisfaction with treatment, investigation of localized treatment should be a priority for researchers with goals to improve the current standard of care.
UV light has a wavelength of 10nm - 380nm, which is slightly shorter than the wavelength of visible light. The UV light can be further classified to a narrow spectrum (UVB light has a wavelength of 280-315 nm). UVA has a wavelength of 315-400nm. Tanning beds use UV light to produce their effects. Whole body ultraviolet B (UVB) phototherapy is efficacious and is recommended as a first line option in selective psoriasis treatment recommendations. In pregnancy, UVB therapy is recommended as first line treatment for extensive plaque and guttate psoriasis.
Although UVB phototherapy has been included in the guidelines for psoriasis treatment, its use does not come without risk. Toxicities include cataract formation, herpes reactivation, photoaging, and with long-term exposure may lead to an increased risk of genital tumors in males. In addition, the use of UVB is rarely used as a first-line treatment for localized psoriasis probably due to financial issues and increased requirements for clinic visits. Narrowband UVB therapy (emission 311- 313nm) is superior to broad-band UVB light, and reduces toxicity. Psoriatic plaques can withstand much higher doses of UV light than the surrounding uninvolved skin; UV treatment of just the involved skin therefore offers increased efficacy in fewer treatments. In addition, localized treatment may remain in remission even 4 months after clearing with localized laser treatment. Localized treatment should therefore be a more favorable treatment option for psoriasis, using higher doses with sparing of healthy skin.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Laser | Experimental | Device: Psoriashield in the presence of a non-UV absorbing block., Device: Psoriashield in the presence of a UV absorbing block., Device: Psoriashield, Device: Xtrac laser in the presence of a non-UV absorbing block., Device: Xtrac in the presence of a UV absorbing block., Device: Xtrac laserAll six interventions will be applied to patient's back. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male and female subjects older than 18 years of age.
- Good health as determined by lack of clinically significant abnormalities in medical history and clinical assessment, as judged by the Investigator.
- Subject is capable of understanding and willing to provide a signed and dated written voluntary informed consent before any protocol specific procedures are performed.
- The subject is able to complete the study and comply with study instructions, including attending all study visits.
- If a female subject of childbearing potential, subject has a negative urine pregnancy test.
Key exclusion criteria (11 listed)
- Subject has a history of being non-responsive to UVB therapy
- Subject received phototherapy in the past four weeks
- Subject used topical therapy within two weeks from baseline (Excluding emollients)
- Subject has used experimental drugs or devices at least one month prior to Baseline
- Subject has a known history of Photosensitivity disorder (Including Xeroderma pigmentosum, SLE, Cockayne Syndrome, Bloom Syndrome) or is currently taking any medication that causes photosensitivity that requires they avoid sunlight.
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 |
|---|---|---|
| Psoriashield in the presence of a non-UV absorbing block.The psoriashield will be applied to patient's back in the presence of a non-UV absorbing block. | Device | Laser |
| Psoriashield in the presence of a UV absorbing block.The psoriashield will be applied to patient's back in the presence of a UV absorbing block. | Device | Laser |
| PsoriashieldThe psoriashield will be applied to patient's back. | Device | Laser |
| Xtrac laser in the presence of a non-UV absorbing block.The Xtrac laser will be applied to patient's back in the presence of a UV absorbing block. | Device | Laser |
| Xtrac in the presence of a UV absorbing block.The Xtrac laser will be applied to patient's back in the presence of a non-UV absorbing block. | Device | Laser |
| Xtrac laserThe Xtrac laser will be applied to patient's back. | Device | Laser |
Primary outcome
MED Reading
Time frame: 24 hours
Minimal Erythemal Dose
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2019.
- Background: PubMed 12063488Feldman SR, Mellen BG, Housman TS, Fitzpatrick RE, Geronemus RG, Friedman PM, Vasily DB, Morison WL. Efficacy of the 308-nm excimer laser for treatment of psoriasis: results of a multicenter study. J Am Acad Dermatol. 2002 Jun;46(6):900-6. doi: 10.1067/mjd.2002.120454.
- Background: PubMed 10365919Walters IB, Burack LH, Coven TR, Gilleaudeau P, Krueger JG. Suberythemogenic narrow-band UVB is markedly more effective than conventional UVB in treatment of psoriasis vulgaris. J Am Acad Dermatol. 1999 Jun;40(6 Pt 1):893-900. doi: 10.1016/s0190-9622(99)70076-9.
- 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.
Steven R Feldman, MD PhD principal investigator
Wake Forest University Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Psoriashield in the presence of a non-UV absorbing block., Psoriashield in the presence of a UV absorbing block. and Psoriashield in people with Healthy Participants and/or Patients, run by Wake Forest University Health Sciences 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 5 inclusion and 11 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: withdrawn, as of the sponsor's last update on 29 Aug 2019. 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 was withdrawn before enrolling participants, so there are no results.
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?
MED Reading (time frame: 24 hours). 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 NCT03049319, which also lists 2 linked publications.
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 29 Aug 2019.