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| Sponsor: | University of California, San Francisco |
|---|---|
| Information provided by: | University of California, San Francisco |
| ClinicalTrials.gov Identifier: | NCT00924950 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Plaque Psoriasis Psoriasis Vulgaris |
Drug: Taclonex Ointment and Hydrogel Patch Drug: Taclonex Ointment |
Phase IV |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| 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 |
| Enrollment: | 35 |
| Study Start Date: | June 2009 |
| Study Completion Date: | December 2009 |
| Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Taclonex Ointment with Hydrogel Patch
Taclonex ointment used daily to treat one psoriatic plaque, along with the Hydrogel Patch used daily.
|
Drug: Taclonex Ointment and Hydrogel Patch
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.
|
| Active Comparator: Taclonex Ointment |
Drug: Taclonex Ointment
Taclonex ointment daily for one psoriatic plaque.
|
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 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 UVB phototherapy as long as it does not impact on the two target lesions.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, California | |
| UCSF Psoriasis Skin and Treatment Center | |
| San Francisco, California, United States, 94118 | |
| Principal Investigator: | John Koo, MD | University of California, San Francisco |
More Information
| Responsible Party: | John Koo MD, University of California San Francisco |
| ClinicalTrials.gov Identifier: | NCT00924950 History of Changes |
| Other Study ID Numbers: | H5939-31328-02 |
| Study First Received: | June 17, 2009 |
| Last Updated: | January 15, 2010 |
| Health Authority: | United States: Institutional Review Board |
|
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. |
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Psoriasis Skin Diseases, Papulosquamous Skin Diseases |