Plaque Psoriasis Clinical Trial
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.
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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