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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Taclonex Ointment Topically Once Daily | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Taclonex Ointment and Hydrogel Patch | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 6 Weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| John Koo, MD | University of California, San Francisco | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UCSF Psoriasis Skin and Treatment Center | San Francisco | California | 94118 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 7534777 | Background | 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. | |
| 15663344 | Background | 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. |
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Patients were assessed for psoriasis severity as well as washout from other concomitant medications
Recruitment took place at the University of California at San Francisco (UCSF) Psoriasis and Skin Treatment Center.
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| ID | Title | Description |
|---|---|---|
| FG000 | Ointment + Patch vs. Ointment Alone | Taclonex (calcipotriene 0.005% and betamethasone dipropionate 0.064%) ointment used topically to treat one psoriatic plaque with Hydrogel patch used over for occlusion for 6-8 hours daily. Within the same patient another patch of similar severity was chosen and was treated with Taclonex ointment alone without hydrogel patch occlusion |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Ointment + Patch vs. Ointment Alone |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | The number of participants was chosen by our budget restrictions. 35 patients were enrolled. 5 patients were lost to follow-up. | Posted | Mean | 95% Confidence Interval | Units on a scale | 4 weeks |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Ointment + Patch vs. Ointment Alone |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Tina Bhutani | UCSF | 4154763396 | tinabhutanimd@gmail.com |
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| ID | Term |
|---|---|
| D011565 | Psoriasis |
| D018232 | Rhabdomyosarcoma, Alveolar |
| ID | Term |
|---|---|
| D017444 | Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D012208 | Rhabdomyosarcoma |
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| Taclonex Ointment | Drug | Taclonex ointment daily for one psoriatic plaque. |
|
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Taclonex Alone |
Taclonex (calcipotriene 0.005% and betamethasone dipropionate 0.064%) ointment used daily without hydrogel patch. |
|
|
|
| Secondary | 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. | This outcome measure was not analyzed due to termination of the study | Posted | 6 Weeks |
|
|
| 0 |
| 30 |
| 0 |
| 30 |
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| D009217 | Myosarcoma |
| D009379 | Neoplasms, Muscle Tissue |
| D018204 | Neoplasms, Connective and Soft Tissue |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D012509 | Sarcoma |