Comparing the Efficacy of Ultravate Ointment in Combination With Lac-Hydrin Lotion in the Treatment of Psoriasis

This is an interventional treatment trial for Stable Plaque Psoriasis Read More

Inclusion Criteria:

• Clinically diagnosed by an investigator to have stable plaque psoriasis with no more than 10% body surface area involvement.
• A subject must have an overall baseline score of 6 (moderate) or greater based on a twelve-point scale on the Psoriasis Severity Assessment (PSA) form. Elevation, erythema, and scale will each be graded on a four point scale with a maximum total of 12 points. Each of these 3 variables should be scored as at least a two. (Plaque elevation is defined as the total elevation, including adherent scales, relative to the surrounding skin).
• For female patients of childbearing potential, a regular menstrual cycle prior to study entry (a female is considered of childbearing potential unless she is postmenopausal, without a uterus and/or both ovaries, or has had a bilateral tubal ligation).
• Negative urine pregnancy test at the time of study entry (for female patients of childbearing potential).
• Written, informed consent and photographic release.
• Ability to follow study instructions and likely to complete all required visits.

Exclusion Criteria:

• A female subject who is pregnant, nursing an infant or planning a pregnancy during the study (throughout the course of the study, women of childbearing potential must use reliable forms of contraception [i.e., abstinence, spermicides, condoms, or other reliable forms of contraception other than oral contraceptives].
• A subject with any uncontrolled systemic disease. A potential subject in whom therapy for a systemic disease is not yet stabilized will not be considered for entry into the study.
• A subject with the presence of any skin disease that might interfere with the diagnosis or evaluation of the test medications.
• A subject that has a condition or is in a situation which in the investigator's opinion may put the patient at significant risk, may confound the study results, or may interfere significantly with the patient's participation in the study.
• A subject with spontaneously improving or rapidly deteriorating plaque psoriasis.
• A subject with pustular or erythrodermic psoriasis.
• A subject diagnosed by an investigator to have stable plaque psoriasis involvement that exceeds more than 10% of the subject's body surface area.
• Use of systemic agents such as oral retinoids, methotrexate, cyclosporine or systemic corticosteroids within four weeks prior to study entry.
• Use of biologic agents such as alefacept, infliximab, efalizumab, adalimumab, or etanercept within four weeks prior to study entry.
• Use of topical drugs that might alter the course of psoriasis (e.g., corticosteroids, retinoids, vitamin D analogues, salicylic acid, tacrolimus, tar and anthralin,) or has received Ultraviolet B treatment within two weeks prior to study entry.
• Use of phototherapy with psoralen ultraviolet A treatment within four weeks prior to study entry.
• A subject with a known sensitivity to any of the study treatments and/or their components.
• A subject who will require excessive or prolonged exposure to ultraviolet light (e.g., sunlight, tanning beds) during the study.
• A subject who anticipates a need to use other topical or systemic therapy that might alter the course of psoriasis.
• A subject who anticipates the need for surgery or hospitalization during the study.
• Concurrent involvement in any other clinical study with an investigational drug or device, or participation in a clinical study within 30 days prior to entering the study.