Plaque PsoriasisPhase 4NCT00924950

Taclonex Ointment With Hydrogel Patch Occlusion for the Treatment of Psoriasis

A Phase 4 study testing Taclonex Ointment and Hydrogel Patch and Taclonex Ointment in people with Plaque Psoriasis and Psoriasis Vulgaris, run by University of California, San Francisco at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Plaque Psoriasis, Psoriasis Vulgaris
What is being tested?: Taclonex Ointment and Hydrogel Patch and Taclonex Ointment
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 35 participants
Where: 1 siteUnited States
Study dates: Jun 2009to Dec 2009
Phase: Phase 4
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

Subject has signed the informed consent form and Health Information Portability and Accountability Act (HIPAA) authorization form;
Male or female subject at least 18 years of age;
A diagnosis of stable plaque-type psoriasis vulgaris with at least one pair of symmetric lesions on either the trunk, arms, or legs that would serve as target lesions. Paired target lesions must be in similar anatomic locations (e.g., right and left elbows or right and left knees) and have roughly equivalent (no more than one point difference) modified Psoriasis Area Severity Index (PASI) scores. Each paired target lesions must have PASI scores equal to or greater than 7;
Any additional diagnoses must, in the investigator's opinion, not preclude the subject from safely participating in this study or interfere with the evaluation of the subject's psoriasis;
Psoriasis must be clinically stable for at least 30 days before enrollment;
Subject is able to discontinue the use of any medication or therapy for relief of psoriasis in the target areas to be treated;

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Subject is able to discontinue the use of any systemic medication or therapy (e.g. oral or injectable psoriasis medications, PUVA photochemotherapy, herbal remedies, etc.) for psoriasis;
Subject must be reliable and mentally competent to complete study measurements;
Subject is able to understand and agrees to comply with study requirements, attend study visits, and comply with the restrictions during the study.

Who cannot join

Subject has a skin disorder other than psoriasis in the target areas to be evaluated;
Known hypersensitivity to any component of the test medications;
Pigmentation, extensive scarring, or pigmented lesions in affected areas that would interfere with evaluation of efficacy parameters;
Clinically infected psoriasis at baseline;
Guttate, pustular, erythrodermic, or other non-plaque forms of psoriasis;
Spontaneously worsening or improving psoriasis within 30 days of enrollment;

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Any evidence of atrophy in the areas selected for treatment with topical corticosteroid;
Topical or intralesional therapies (other than emollients) or UVB phototherapy on potential target lesions within two weeks of starting study treatment;
Systemic therapy, PUVA phototherapy, or a systemic investigational therapy for psoriasis within 30 days prior to study entry;
Treatment with topical investigational therapy of the target lesions within 30 days prior to study entry;
Subject is considered unreliable as to medication compliance or adherence to scheduled appointments as determined by the investigators.
Subject is pregnant

Trial locations and contacts

1 site in 1 country.

United States1 site

UCSF Psoriasis Skin and Treatment Center
San Francisco, California, 94118

Other trials in United States

About this study

Official title: An Open-Label, Bilaterally-Controlled Single Center Study to Compare the Efficacy of Taclonex Ointment With Hydrogel Patch Occlusion to Taclonex Ointment Without Occlusion in the Treatment of Plaque-Type Psoriasis

The purpose of this study is to determine whether using Taclonex ointment under a hydrogel patch is more effective than using the ointment alone in treating psoriasis. Taclonex ointment is currently FDA approved for use on psoriasis. The hydrogel patch is a type of adhesive pad and contains no medications. It is currently FDA approved and has been shown to be safe and virtually free of side effects. The hypothesis is that psoriatic plaques which are treated with Taclonex ointment under a hydrogel patch will be more effectively treated compared to psoriatic plaques treated with Taclonex alone.

Read the detailed description

This will be an open label, bilaterally-controlled single center study. Thirty subjects with plaque type psoriasis will be enrolled in the study. All subjects will receive treatment on two target lesions that are similar in erythema, scaling and induration, and symmetric in anatomic location. The severity of their target lesions will be assessed using a modified Psoriasis Area and Severity Index (PASI) scoring system (Appendix A). Symmetrical target lesions must each be rated at a PASI score equal to or greater than 7 and be within 1 PASI score of each other.

All subjects will apply Taclonex ointment to both target lesions once daily for 4 weeks. The occlusive dressing will be applied by the subject to one of the two symmetrical target lesions once daily for 4 weeks. The occlusive dressing will be removed by the patient if he/she experiences warmth, irritation, increased erythema, and/or itching. If the patch is removed due to these symptoms and signs, the subject will leave the lesion un-occluded until for 24 hours, at which time a new occlusive dressing will be placed.

After the initial 4 weeks of treatment, there will be a follow up period of 6 weeks during which no treatment is used.

Subjects will be restricted from using systemic therapies for psoriasis during this study, including Psoralen Ultraviolet A (PUVA) photochemotherapy and herbal therapies. All topical medications, except the study medications, and UVB phototherapy are prohibited on the target lesions. All of the other psoriasis lesions on the body can be treated as usual with other topical medications and Ultraviolet B (UVB) phototherapy as long as it does not impact on the two target lesions.

Conditions: Plaque Psoriasis, Psoriasis Vulgaris
Being tested: Taclonex Ointment and Hydrogel Patch, Taclonex Ointment
Keywords: Psoriasis, Plaque psoriasis, with bilateral symmetrical lesions., A diagnosis of stable plaque-type psoriasis vulgaris, with at least one pair of symmetric lesions on either, the trunk, arms, or legs that would serve as target lesions.
Medical subject headings: Psoriasis, Rhabdomyosarcoma, Alveolar

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Taclonex Ointment and Hydrogel PatchDrug
Each patient will have bilateral symmetrical psoriatic plaques. One plaque will be treated with Taclonex Ointment daily along with Hydrogel Patch daily. All treatment will be for 4 weeks.
Taclonex OintmentDrug
Taclonex ointment daily for one psoriatic plaque.

Study groups in NCT00924950
Study group	Role	What they receive
Taclonex Ointment/Hydrogel Patch Applied Topically Once Daily	Active comparator	Taclonex ointment once daily used to treat one psoriatic plaque, along with the Hydrogel Patch used once daily. Receives: Drug: Taclonex Ointment and Hydrogel Patch
Taclonex Ointment Topically Once Daily	Active comparator	Not described Receives: Drug: Taclonex Ointment

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in Total Modified PASI Score at Week 4 Compared to Baseline
Modified psoriasis severity index measures erythema, induration, and scaling each measured from 0-4, with a maximum summed score of 12. A higher score means greater psoriasis severity and a lower score means lower psoriasis severity.
Measured: 4 weeks

Secondary outcomes (1)

Change in Modified PASI Scores Between Week 4 and Week 6 During the Follow-up Period. This is to Determine Whether There is Further Improvement of Psoriasis After the Cessation of Occlusion
Change in Modified PASI Scores Between Week 4 and Week 6 During the Follow-up Period. This is to Determine Whether There is Further Improvement of Psoriasis After the Cessation of Occlusion.
Measured: 6 Weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jun 2009Dec 2009

First posted19 Jun 2009 (estimated)
Study startJun 2009
Primary completionDec 2009
Study completionDec 2009

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 (2)Papers the sponsor has linked to this study.
Other trials for Plaque PsoriasisStudies of the same condition, open and under way.
More trials run by University of California, San FranciscoThe 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 4
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Enrolment: 35 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00924950
Sponsor's protocol ID: H5939-31328-02
Status last verified: Apr 2019
First submitted: 17 Jun 2009
Last updated: 18 Apr 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Griffiths CE, Tranfaglia MG, Kang S. Prolonged occlusion in the treatment of psoriasis: a clinical and immunohistologic study. J Am Acad Dermatol. 1995 Apr;32(4):618-22. doi: 10.1016/0190-9622(95)90347-x.
PubMed 7534777
Fenton C, Plosker GL. Calcipotriol/betamethasone dipropionate: a review of its use in the treatment of psoriasis vulgaris. Am J Clin Dermatol. 2004;5(6):463-78. doi: 10.2165/00128071-200405060-00012.
PubMed 15663344

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Not yet recruitingPhase 3
A Study of Zasocitinib in Adults With Non-pustular Palmoplantar Psoriasis
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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
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All Plaque Psoriasis trials

Study at a glance

From the registry record, last updated by the sponsor on 18 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Open-Label, Bilaterally-Controlled Single Center Study to Compare the Efficacy of Taclonex Ointment With Hydrogel Patch Occlusion to Taclonex Ointment Without Occlusion in the Treatment of Plaque-Type Psoriasis
ClinicalTrials.gov ID: NCT00924950
Acronym / sponsor ID: H5939-31328-02
Conditions: Plaque Psoriasis, Psoriasis Vulgaris
Keywords: Psoriasis, Plaque psoriasis, with bilateral symmetrical lesions., A diagnosis of stable plaque-type psoriasis vulgaris, with at least one pair of symmetric lesions on either, the trunk, arms, or legs that would serve as target lesions.
Phase: Phase 4
Study type: Interventional
Recruitment status: Terminated
Enrolment: 35 participants (actual)
Lead sponsor: University of California, San FranciscoUniversity, hospital or other
Study start: Jun 2009
Primary completion: Dec 2009 (actual)
Study completion: Dec 2009 (actual)
First posted: 19 Jun 2009 (estimated)
Results: Posted 5 Dec 2012

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

After the initial 4 weeks of treatment, there will be a follow up period of 6 weeks during which no treatment is used.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Taclonex Ointment/Hydrogel Patch Applied Topically Once Daily	Active comparator	Drug: Taclonex Ointment and Hydrogel PatchTaclonex ointment once daily used to treat one psoriatic plaque, along with the Hydrogel Patch used once daily.
Taclonex Ointment Topically Once Daily	Active comparator	Drug: Taclonex Ointment

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (9 listed)

Subject has signed the informed consent form and Health Information Portability and Accountability Act (HIPAA) authorization form;
Male or female subject at least 18 years of age;
A diagnosis of stable plaque-type psoriasis vulgaris with at least one pair of symmetric lesions on either the trunk, arms, or legs that would serve as target lesions. Paired target lesions must be in similar anatomic locations (e.g., right and left elbows or right and left knees) and have roughly equivalent (no more than one point difference) modified Psoriasis Area Severity Index (PASI) scores. Each paired target lesions must have PASI scores equal to or greater than 7;
Any additional diagnoses must, in the investigator's opinion, not preclude the subject from safely participating in this study or interfere with the evaluation of the subject's psoriasis;
Psoriasis must be clinically stable for at least 30 days before enrollment;

Key exclusion criteria (12 listed)

Subject has a skin disorder other than psoriasis in the target areas to be evaluated;
Known hypersensitivity to any component of the test medications;
Pigmentation, extensive scarring, or pigmented lesions in affected areas that would interfere with evaluation of efficacy parameters;
Clinically infected psoriasis at baseline;
Guttate, pustular, erythrodermic, or other non-plaque forms of psoriasis;

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
Taclonex Ointment and Hydrogel PatchEach patient will have bilateral symmetrical psoriatic plaques. One plaque will be treated with Taclonex Ointment daily along with Hydrogel Patch daily. All treatment will be for 4 weeks.	Drug	Taclonex Ointment/Hydrogel Patch Applied Topically Once Daily
Taclonex OintmentTaclonex ointment daily for one psoriatic plaque.	Drug	Taclonex Ointment Topically Once Daily

Primary outcome

Change in Total Modified PASI Score at Week 4 Compared to Baseline
Time frame: 4 weeks
Modified psoriasis severity index measures erythema, induration, and scaling each measured from 0-4, with a maximum summed score of 12. A higher score means greater psoriasis severity and a lower score means lower psoriasis severity.

1 secondary outcome

Change in Modified PASI Scores Between Week 4 and Week 6 During the Follow-up Period. This is to Determine Whether There is Further Improvement of Psoriasis After the Cessation of Occlusion
Time frame: 6 Weeks

Results and safety

Results posted to the registry on 5 Dec 2012, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Ointment + Patch vs. Ointment Alone	30	28

Primary outcome: Change in Total Modified PASI Score at Week 4 Compared to Baseline

Time frame: 4 weeks. Mean (95% Confidence Interval). Unit: Units on a scale

Measure	Taclonex Ointment Occluded With Hydrogel Patch n = 30	Taclonex Alone n = 30
Value	0.86 (0.40 to 1.31)	2.2 (1.7 to 3.58)

Taclonex Ointment Occluded With Hydrogel Patch vs Taclonex Alone: Mean Difference (Final Values): 0.8571, p = 0.0008, t-test, 2 sided

Population analysed: The number of participants was chosen by our budget restrictions. 35 patients were enrolled. 5 patients were lost to follow-up.

1 secondary outcome is reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Ointment + Patch vs. Ointment Alone	0 of 30 (0%)	0 of 30 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 7534777Griffiths CE, Tranfaglia MG, Kang S. Prolonged occlusion in the treatment of psoriasis: a clinical and immunohistologic study. J Am Acad Dermatol. 1995 Apr;32(4):618-22. doi: 10.1016/0190-9622(95)90347-x.
Background: PubMed 15663344Fenton C, Plosker GL. Calcipotriol/betamethasone dipropionate: a review of its use in the treatment of psoriasis vulgaris. Am J Clin Dermatol. 2004;5(6):463-78. doi: 10.2165/00128071-200405060-00012.

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.

John Koo, MD principal investigator

University of California, San Francisco

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 9 inclusion and 12 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 18 Apr 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.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 5 Dec 2012). 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 Total Modified PASI Score at Week 4 Compared to Baseline (time frame: 4 weeks). 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 NCT00924950, 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 18 Apr 2019.