Status:
COMPLETED
Comparing the Efficacy of Ultravate Ointment in Combination With Lac-Hydrin Lotion in the Treatment of Psoriasis
Lead Sponsor:
University of California, San Francisco
Conditions:
Stable Plaque Psoriasis
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
This is an investigator-masked, randomized, parallel, clinical study comparing the efficacy of once daily versus twice daily application of Ultravate® ointment (halobetasol propionate 0.05% ointment) ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2010
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00990561
Start Date
July 1 2009
End Date
June 1 2010
Last Update
January 4 2019
Active Locations (1)
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1
UCSF Psoriasis and Skin Treatment Center
San Francisco, California, United States, 94118