PsoriasisNCT01094717
Acitretin or Tazarotene Gel and Excimer Laser for Treatment of Psoriasis
A study testing Acitretin 25Mg Oral Capsule, Excimer laser and Tazarotene 0.1% Gel,Top in people with Psoriasis, run by University of Utah at 1 site in United States.
Trial summary
This is a randomized, double-blind study of excimer (308-nm UVB) laser added to either tazarotene 0.1% gel or acitretin 25 mg daily for plaque psoriasis. The primary objective of this study is to compare the improvement of psoriatic plaques with and without excimer laser (308-nm UVB) treatment, applied in a randomized… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Psoriasis
- What is being tested?
- Acitretin 25Mg Oral Capsule, Excimer laser and Tazarotene 0.1% Gel,Top
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 13 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2010to Oct 2011
- 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
- Must give written informed consent
- Must be at least 18 years old
- Must have been diagnosed with stable plaque type psoriasis covering between 1 and 5% BSA
- NPF-PS ≥8 (based additive scores averaged over all lesions for erythema, scale, and thickness range of score = 0-5)
- No systemic or phototherapy in the 4 wks prior to entering the study
- No topical therapy other than emollients (no corticosteroids, vitamin D analogs, vitamin A analogs) in the 2 wks prior to entering the study
- Women on tazarotene gel must not be pregnant nor planning to become pregnant during the study and must be on two forms of birth control
- Subjects known to not tolerate oral acitretin at 25 mg/day and women of child-bearing potential may be enrolled and treated with topical tazarotene gel 0.1%
Who cannot join
- Candidates will be excluded from study entry if any of the following exclusion criteria exist at the time of enrollment:
- Unstable disease
- Only treatable sites are in intertriginous areas or on face
- Subjects unable to tolerate frequency of visits
- NPF-PS severity score <8 additive score of erythema, scale, and thickness, averaged over all lesions
- History of inability to tolerate topical tazarotene 0.1% gel and or acitretin 25 mg/day
- Women of childbearing potential are excluded from the actretin arm of the study.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Utah Department of Dermatology
Salt Lake City, Utah, 84132
About this study
Official title: A Comparison of Treatment of Psoriasis With Acitretin or Tazarotene Gel 0.1% and Active or Sham Treatments With the 308 nm Excimer Laser
This is a randomized, double-blind study of excimer (308-nm UVB) laser added to either tazarotene 0.1% gel or acitretin 25 mg daily for plaque psoriasis.
The primary objective of this study is to compare the improvement of psoriatic plaques with and without excimer laser (308-nm UVB) treatment, applied in a randomized and blinded fashion, in subjects on acitretin 25 mg or tazarotene gel 0.1% QD.
Read the detailed description
The hypothesis of this study is that excimer (308-nm UVB) laser added to either tazarotene 0.1% gel or acitretin 25 mg daily will lead to improved efficacy of these treatments alone.
The primary objective of this study is to compare the improvement of psoriatic plaques with and without excimer laser (308-nm UVB) treatment, applied in a randomized and blinded fashion, in subjects on acitretin 25 mg or tazarotene gel 0.1% QD. The primary endpoint will be the comparison between the change in NPF score of plaques treated with excimer laser and those treated with sham treatment.
The secondary objectives are to compare the number of excimer light treatments and time necessary to achieve an average lesion assessment score of 0 to 1 in subjects treated with acitretin 25 mg PO or tazarotene gel 0.1% QD, and to evaluate adverse events related to combinations of the study treatments.
- Conditions
- Psoriasis
- Being tested
- Acitretin 25Mg Oral Capsule, Excimer laser, Tazarotene 0.1% Gel,Top, Sham excimer laser
- Keywords
- psoriasis, excimer, acitretin, tazarotene
- Medical subject headings
- Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acitretin 25Mg Oral CapsuleDrug
Acitretin 25 mg oral daily for 12 weeks
Excimer laserDevice
Lesions on randomly assigned left or right side of body were treated with 308nm excimer laser.
Tazarotene 0.1% Gel,TopDrug
Topical tazarotene 0.1% gel was applied daily to active lesions.
Sham excimer laserDevice
Lesions on randomly assigned left or right side of body were treated with sham excimer laser (opaque cover on the laser device).
| Study group | Role | What they receive |
|---|---|---|
| acitretin and active excimer laser | Experimental | patients enrolled in the acitretin arm will be treated with acitretin 25 mg daily and excimer (active) to randomly assigned left or right side of body psoriasis lesions. Receives: Drug: Acitretin 25Mg Oral Capsule; Device: Excimer laser |
| acitretin and sham excimer laser | Experimental | Patients in this arm were treated with acitretin 25 mg daily and sham (placebo) excimer laser to randomly assigned left or right side of body psoriasis lesions. Receives: Drug: Acitretin 25Mg Oral Capsule; Device: Sham excimer laser |
| tazarotene and active excimer laser | Experimental | patients enrolled in this arm were treated with tazarotene 0.1% gel topical application daily and excimer (active) laser to randomly assigned left or right side of body psoriasis lesions. Receives: Device: Excimer laser; Drug: Tazarotene 0.1% Gel,Top |
| tazarotene and sham excimer laser | Experimental | patients enrolled in this arm were treated with tazarotene 0.1% gel topical application daily and sham excimer laser to randomly assigned left or right side of body psoriasis lesions. Receives: Drug: Tazarotene 0.1% Gel,Top; Device: Sham excimer laser |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the NPF Psoriasis Score of Plaques
mean % change in the National Psoriasis Foundation (NPF) psoriasis score of the target plaques [higher percent change in NPF score is consistent with improvement, while higher absolute NPF score is consistent with worse disease, minimum score of 0 (no disease) and maximum score of 30 (worst disease)]
Measured: week 8
Secondary outcomes (2)
Number of Patients That Achieved an Average Lesion Assessment Score of 0 or 1 at Week 12.
number of patients who achieved average lesion assessment score of 0 or 1 by the Target Plaque Sum Score (TPSS) for each arm/intervention. For the TPSS, the target plaque was assessed separately for induration, scaling, and erythema using a 6-point severity scale (0 = none and 5 = severe) and the scores were summed to produce the Target Plaque Sum Score [15-point scale; maximum (most severe) score 15].
Measured: 8 weeks
Number of Participants With Adverse Events
We will collect number and types of adverse events for the excimer-treated vs. sham-treated sites
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2010 (estimated)
- Study startJan 2010
- Primary completionSep 2011
- Study completionOct 2011
Why it stopped: lack of efficacy and lack of funding
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 PsoriasisStudies of the same condition, open and under way.
- More trials run by University of UtahThe 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
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Utah
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kristina Callis, University of Utah
- Investigators
- Kristina C Duffin, MD, Principal investigator, University of Utah
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01094717
- Sponsor's protocol ID
- IRB_00031865
- Status last verified
- Jun 2019
- First submitted
- 25 Mar 2010
- Last updated
- 26 Jun 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of Treatment of Psoriasis With Acitretin or Tazarotene Gel 0.1% and Active or Sham Treatments With the 308 nm Excimer Laser
- ClinicalTrials.gov ID
- NCT01094717
- Acronym / sponsor ID
- IRB_00031865
- Conditions
- Psoriasis
- Keywords
- psoriasis, excimer, acitretin, tazarotene
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: lack of efficacy and lack of funding
- Enrolment
- 13 participants (actual)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Study start
- Jan 2010
- Primary completion
- Sep 2011 (actual)
- Study completion
- Oct 2011 (actual)
- First posted
- 29 Mar 2010 (estimated)
- Results
- Posted 26 Jun 2019
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 randomized, double-blind study of excimer (308-nm UVB) laser added to either tazarotene 0.1% gel or acitretin 25 mg daily for plaque psoriasis.
The primary objective of this study is to compare the improvement of psoriatic plaques with and without excimer laser (308-nm UVB) treatment, applied in a randomized and blinded fashion, in subjects on acitretin 25 mg or tazarotene gel 0.1% QD.
Detailed description
The hypothesis of this study is that excimer (308-nm UVB) laser added to either tazarotene 0.1% gel or acitretin 25 mg daily will lead to improved efficacy of these treatments alone.
The primary objective of this study is to compare the improvement of psoriatic plaques with and without excimer laser (308-nm UVB) treatment, applied in a randomized and blinded fashion, in subjects on acitretin 25 mg or tazarotene gel 0.1% QD. The primary endpoint will be the comparison between the change in NPF score of plaques treated with excimer laser and those treated with sham treatment.
The secondary objectives are to compare the number of excimer light treatments and time necessary to achieve an average lesion assessment score of 0 to 1 in subjects treated with acitretin 25 mg PO or tazarotene gel 0.1% QD, and to evaluate adverse events related to combinations of the study treatments.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| acitretin and active excimer laser | Experimental | Drug: Acitretin 25Mg Oral Capsule, Device: Excimer laserpatients enrolled in the acitretin arm will be treated with acitretin 25 mg daily and excimer (active) to randomly assigned left or right side of body psoriasis lesions. |
| acitretin and sham excimer laser | Experimental | Drug: Acitretin 25Mg Oral Capsule, Device: Sham excimer laserPatients in this arm were treated with acitretin 25 mg daily and sham (placebo) excimer laser to randomly assigned left or right side of body psoriasis lesions. |
| tazarotene and active excimer laser | Experimental | Device: Excimer laser, Drug: Tazarotene 0.1% Gel,Toppatients enrolled in this arm were treated with tazarotene 0.1% gel topical application daily and excimer (active) laser to randomly assigned left or right side of body psoriasis lesions. |
| tazarotene and sham excimer laser | Experimental | Drug: Tazarotene 0.1% Gel,Top, Device: Sham excimer laserpatients enrolled in this arm were treated with tazarotene 0.1% gel topical application daily and sham excimer laser to randomly assigned left or right side of body psoriasis lesions. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Must give written informed consent
- Must be at least 18 years old
- Must have been diagnosed with stable plaque type psoriasis covering between 1 and 5% BSA
- NPF-PS ≥8 (based additive scores averaged over all lesions for erythema, scale, and thickness range of score = 0-5)
- No systemic or phototherapy in the 4 wks prior to entering the study
Key exclusion criteria (7 listed)
- Candidates will be excluded from study entry if any of the following exclusion criteria exist at the time of enrollment:
- Unstable disease
- Only treatable sites are in intertriginous areas or on face
- Subjects unable to tolerate frequency of visits
- NPF-PS severity score <8 additive score of erythema, scale, and thickness, averaged over all lesions
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 |
|---|---|---|
| Acitretin 25Mg Oral CapsuleAcitretin 25 mg oral daily for 12 weeks | Drug | acitretin and active excimer laser, acitretin and sham excimer laser |
| Excimer laserLesions on randomly assigned left or right side of body were treated with 308nm excimer laser. | Device | acitretin and active excimer laser, tazarotene and active excimer laser |
| Tazarotene 0.1% Gel,TopTopical tazarotene 0.1% gel was applied daily to active lesions. | Drug | tazarotene and active excimer laser, tazarotene and sham excimer laser |
| Sham excimer laserLesions on randomly assigned left or right side of body were treated with sham excimer laser (opaque cover on the laser device). | Device | acitretin and sham excimer laser, tazarotene and sham excimer laser |
Primary outcome
Change in the NPF Psoriasis Score of Plaques
Time frame: week 8
mean % change in the National Psoriasis Foundation (NPF) psoriasis score of the target plaques [higher percent change in NPF score is consistent with improvement, while higher absolute NPF score is consistent with worse disease, minimum score of 0 (no disease) and maximum score of 30 (worst disease)]
2 secondary outcomes
Number of Patients That Achieved an Average Lesion Assessment Score of 0 or 1 at Week 12.
Time frame: 8 weeks
Number of Participants With Adverse Events
Time frame: 12 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Kristina C Duffin, MD principal investigator
University of Utah
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acitretin 25Mg Oral Capsule, Excimer laser and Tazarotene 0.1% Gel,Top in people with Psoriasis, run by University of Utah 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 8 inclusion and 7 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: stopped early, as of the sponsor's last update on 26 Jun 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?
Yes. Results are posted in the registry (first posted 26 Jun 2019). 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?
Change in the NPF Psoriasis Score of Plaques (time frame: week 8). 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 26 Jun 2019.