Plaque PsoriasisNCT00708851
NB-UVB Phototherapy With and Without Topical LCD Treatment: a Bilateral Pilot Study
A study testing LCD Solution with NB-UVB Phototherapy and NB-UVB Light Device (311-315 nm) in people with Plaque Psoriasis, run by NeoStrata Company, Inc. at 1 site in United States.
Trial summary
The purpose of this study is to determine if combining a daily at-home regimen using an LCD Solution with a 3 times weekly outpatient narrowband UVB phototherapy regimen could be a safe, effective, rapid, and, convenient treatment for plaque psoriasis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Plaque Psoriasis
- What is being tested?
- LCD Solution with NB-UVB Phototherapy and NB-UVB Light Device (311-315 nm)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2007to Mar 2008
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years old or older
- able and willing to provide written informed consent
- symmetrical plaque psoriasis
- able and willing to attend phototherapy sessions and apply LCD at home
- negative pregnancy test for women of child-bearing potential
Who cannot join
- current or recent other treatments for psoriasis
- hypersensitivity to LCD or UVB light
- current or previous skin cancer
- pregnant or nursing mother
- participating in another clinical trial
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Clinical Evaluation of Safety & Efficacy of Adding an At-home Topical LCD Solution Regimen to Standard Narrowband UVB Phototherapy Administered 3 Times Weekly to Adults With Generalized Plaque Psoriasis.
The purpose of this study is to determine if combining a daily at-home regimen using an LCD Solution with a 3 times weekly outpatient narrowband UVB phototherapy regimen could be a safe, effective, rapid, and, convenient treatment for plaque psoriasis.
Read the detailed description
Use of coal tar with narrowband (NB) ultraviolet B (UVB) light (the Goeckermen regimen) is an effective treatment for plaque psoriasis that has become impractical in outpatient care mainly due to the inconvenience and aesthetic concerns of coal tar. This study aims to evaluate the safety, efficacy, and convenience of adding a novel liquor carbonis distillate (LCD) (coal tar) solution to standard NB_UVB phototherapy in adults with chronic plaque psoriasis. Patients will apply LCD solution to half the body, twice daily at home and receive outpatient full-body NB-UVB light therapy 3 times a week for up to 12 weeks. A blinded investigator will grade psoriasis severity of body halves and bilateral target lesions and monitor adverse reactions. Patients will rate their psoriasis symptoms and LCD solution aesthetics. Incorporating an at-home regimen with a novel LCD solution into outpatient NB-UVB light therapy is safe, convenient, and effective and can improve psoriasis more quickly than NB-UVB light therapy alone.
- Conditions
- Plaque Psoriasis
- Being tested
- LCD Solution with NB-UVB Phototherapy, NB-UVB Light Device (311-315 nm)
- Keywords
- psoriasis
- Medical subject headings
- Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LCD Solution with NB-UVB PhototherapyOther
Also called LCD
LCD Solution: 2 applications / day
NB-UVB Phototherapy: 3 light sessions / week
NB-UVB Light Device (311-315 nm)Device
Also called Ultralite Model # V4848NB
NB-UVB Phototherapy: 3 light exposures / week
| Study group | Role | What they receive |
|---|---|---|
| NB-UVB Light Device (311-315 nm) | Active comparator | the subject will receive full body NB-UVB light therapy Receives: Device: NB-UVB Light Device (311-315 nm) |
| LCD Solution with NB-UVB Phototherapy | Experimental | on half of the body will receive LCD while the full body receives NB-UVB therapy Receives: Other: LCD Solution with NB-UVB Phototherapy; Device: NB-UVB Light Device (311-315 nm) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Difference in Bilateral Static Physician's Global Assessment (sPGA) Scores, and Erythema, Scaling, and Induration (ESI) Scores of Bilateral Target Lesion Scores Across Visits for Each Condition and Between Conditions.
Twelve (12) participants were followed over a 12-week treatment period. Treatment was administered bilaterally as they applied LCD solution to one half of their body while receiving full-body NB-UVB light therapy. The difference in their sPGA, and ESI scores of bilateral target lesions were measured across all visits. PGA scores are calculated using a 6-point scale from 0 (clear) to 5 (very severe). Erythema, induration and scaling scores use a 5-point scale from 0 (none) to 4 (very severe).
Measured: 12 weeks of treatment
Secondary outcomes (1)
The Difference in Number and Severity of Treatment-related Adverse Reactions Between Conditions.
Number of subjects who experienced and adverse reaction due to UVB + LCD, versus number of subjects who experienced an adverse reaction due to UVB therapy alone.
Measured: 12 weeks of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2008 (estimated)
- Study startApr 2007
- Primary completionJan 2008
- Study completionMar 2008
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.
- Other trials for Plaque 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
- Investigator
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- NeoStrata Company, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jerry Bagel, MD, Principal investigator, Windsor Dermatology, East Windsor, NJ 08520
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00708851
- Sponsor's protocol ID
- 07-LCDUVB
- Status last verified
- Apr 2015
- First submitted
- 27 Jun 2008
- Last updated
- 20 Apr 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Evaluation of Safety & Efficacy of Adding an At-home Topical LCD Solution Regimen to Standard Narrowband UVB Phototherapy Administered 3 Times Weekly to Adults With Generalized Plaque Psoriasis.
- ClinicalTrials.gov ID
- NCT00708851
- Acronym / sponsor ID
- 07-LCDUVB
- Conditions
- Plaque Psoriasis
- Keywords
- psoriasis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- NeoStrata Company, Inc.Industry (pharma, biotech, devices)
- Study start
- Apr 2007
- Primary completion
- Jan 2008 (actual)
- Study completion
- Mar 2008 (actual)
- First posted
- 2 Jul 2008 (estimated)
- Results
- Posted 20 Apr 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine if combining a daily at-home regimen using an LCD Solution with a 3 times weekly outpatient narrowband UVB phototherapy regimen could be a safe, effective, rapid, and, convenient treatment for plaque psoriasis.
Detailed description
Use of coal tar with narrowband (NB) ultraviolet B (UVB) light (the Goeckermen regimen) is an effective treatment for plaque psoriasis that has become impractical in outpatient care mainly due to the inconvenience and aesthetic concerns of coal tar. This study aims to evaluate the safety, efficacy, and convenience of adding a novel liquor carbonis distillate (LCD) (coal tar) solution to standard NB_UVB phototherapy in adults with chronic plaque psoriasis. Patients will apply LCD solution to half the body, twice daily at home and receive outpatient full-body NB-UVB light therapy 3 times a week for up to 12 weeks. A blinded investigator will grade psoriasis severity of body halves and bilateral target lesions and monitor adverse reactions. Patients will rate their psoriasis symptoms and LCD solution aesthetics. Incorporating an at-home regimen with a novel LCD solution into outpatient NB-UVB light therapy is safe, convenient, and effective and can improve psoriasis more quickly than NB-UVB light therapy alone.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NB-UVB Light Device (311-315 nm) | Active comparator | Device: NB-UVB Light Device (311-315 nm)the subject will receive full body NB-UVB light therapy |
| LCD Solution with NB-UVB Phototherapy | Experimental | Other: LCD Solution with NB-UVB Phototherapy, Device: NB-UVB Light Device (311-315 nm)on half of the body will receive LCD while the full body receives NB-UVB therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 18 years old or older
- able and willing to provide written informed consent
- symmetrical plaque psoriasis
- able and willing to attend phototherapy sessions and apply LCD at home
- negative pregnancy test for women of child-bearing potential
Key exclusion criteria (5 listed)
- current or recent other treatments for psoriasis
- hypersensitivity to LCD or UVB light
- current or previous skin cancer
- pregnant or nursing mother
- participating in another clinical trial
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 |
|---|---|---|
| LCD Solution with NB-UVB PhototherapyAlso: LCDLCD Solution: 2 applications / day NB-UVB Phototherapy: 3 light sessions / week | Other | LCD Solution with NB-UVB Phototherapy |
| NB-UVB Light Device (311-315 nm)Also: Ultralite Model # V4848NBNB-UVB Phototherapy: 3 light exposures / week | Device | LCD Solution with NB-UVB Phototherapy, NB-UVB Light Device (311-315 nm) |
Primary outcome
The Difference in Bilateral Static Physician's Global Assessment (sPGA) Scores, and Erythema, Scaling, and Induration (ESI) Scores of Bilateral Target Lesion Scores Across Visits for Each Condition and Between Conditions.
Time frame: 12 weeks of treatment
Twelve (12) participants were followed over a 12-week treatment period. Treatment was administered bilaterally as they applied LCD solution to one half of their body while receiving full-body NB-UVB light therapy. The difference in their sPGA, and ESI scores of bilateral target lesions were measured across all visits. PGA scores are calculated using a 6-point scale from 0 (clear) to 5 (very severe). Erythema, induration and scaling scores use a 5-point scale from 0 (none) to 4 (very severe).
1 secondary outcome
The Difference in Number and Severity of Treatment-related Adverse Reactions Between Conditions.
Time frame: 12 weeks of treatment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Plaque Psoriasis
Active, not recruitingPhase 2
Dose Ranging Study of ORKA-001 in Patients With Moderate-to-Severe Plaque Psoriasis
Plaque Psoriasis
RecruitingPhase 1/2
A Study to Evaluate the Efficacy and Safety of CS32582 in Participants With Moderate to Severe Plaque Psoriasis
Plaque Psoriasis
Not yet recruitingPhase 3
A Study of Zasocitinib in Adults With Non-pustular Palmoplantar Psoriasis
Palmoplantar Psoriasis
RecruitingPhase 4
A Study to Investigate the Effectiveness of Tirzepatide (LY3298176) Following Initiation of Ixekizumab (LY2439821) in Participants With Moderate-to-Severe Plaque PsO and Obesity or Overweight in Clinical Practice (TOGETHER AMPLIFY-PsO)
Psoriasis, Overweight or Obesity
Active, not recruitingPhase 3
A Study of JNJ-77242113 for the Treatment of Participants With Moderate to Severe Plaque Psoriasis
Plaque Psoriasis
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.
Jerry Bagel, MD principal investigator
Windsor Dermatology, East Windsor, NJ 08520
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LCD Solution with NB-UVB Phototherapy and NB-UVB Light Device (311-315 nm) in people with Plaque Psoriasis, run by NeoStrata Company, 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 5 inclusion and 5 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 20 Apr 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?
Yes. Results are posted in the registry (first posted 20 Apr 2015). 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?
The Difference in Bilateral Static Physician's Global Assessment (sPGA) Scores, and Erythema, Scaling, and Induration (ESI) Scores of Bilateral Target Lesion Scores Across Visits for Each Condition and Between Conditions. (time frame: 12 weeks of treatment). 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 Apr 2015.