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.
Trial summary
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. Read more about this study
- 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
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 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.
- 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)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- John Koo, MD, Principal investigator, University of California, San Francisco
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 7534777Fenton 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
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.
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.
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.
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
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.
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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.
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?
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.
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.