Taclonex Ointment With Hydrogel Patch Occlusion for the Treatment of Psoriasis
|Plaque Psoriasis Psoriasis Vulgaris||Drug: Taclonex Ointment and Hydrogel Patch Drug: Taclonex Ointment||Phase 4|
|Study Design:||Allocation: Non-Randomized
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|
- Difference in Change Between Baseline and Week 4 Modified Psoriasis Area Severity Index (PASI) Scores in Targeted Plaques Treated With Taclonex Under Occlusive Dressing Versus Taclonex Alone. [ Time Frame: Between Baseline and Week 4 ]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.
- To Determine the 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: Between Week 4 and Week 6 ]
|Study Start Date:||June 2009|
|Study Completion Date:||December 2009|
|Primary Completion Date:||December 2009 (Final data collection date for primary outcome measure)|
Active Comparator: Taclonex Ointment/Hydrogel Patch Applied Topically Once Daily
Taclonex ointment once daily used to treat one psoriatic plaque, along with the Hydrogel Patch used once 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 Topically Once Daily||
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 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00924950
|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|