Pruritis Clinical Trial
Official title:
A Controlled Comparative Study of the Efficacy of SARNA Sensitive Lotion for Treatment of Uremic Pruritus in Adult Hemodialysis Patients
Verified date | August 2018 |
Source | Wake Forest University Health Sciences |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of this research study is to evaluate the efficacy of SARNA Sensitive Lotion in the treatment of uremic pruritus in adult hemodialysis patients in a double-blind Controlled comparative trial.
Status | Completed |
Enrollment | 28 |
Est. completion date | October 2008 |
Est. primary completion date | November 2006 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 70 Years |
Eligibility |
Inclusion Criteria: - Male or female patients 18 years of age to 70 years of age. - A diagnosis of moderate to severe pruritus. - At least 3 episodes of itch over a period of 2 weeks, each lasting for 2 minutes or more. - Symptoms of itch in regular pattern over 6 months. - Itch Visual analog scale (VAS) of 3cm or more out of 10 cm. - All subjects will be end stage renal failure patients undergoing hemodialysis for at least 3 months, who have substantial pruritus for more than 6 months. Substantial pruritus is defined as persistent pruritus impairing sleep or daytime activity. - Ability and willingness to follow all study procedures, attend all scheduled visits, and successfully complete the study - The ability to understand and sign a written informed consent form, which must be obtained prior to treatment. Exclusion Criteria: - Presence of infection (as defined by the investigator) on the area to be treated. - Subjects with history of pruritus predating renal failure and subjects with skin disease unrelated to uremia, such as atopic dermatitis, will be excluded. - Use of systemic medications for treatment of pruritus including corticosteroids within the past 4 weeks and during the study. - Use of topical medications for treatment of pruritus, including corticosteroids, within the past week. - Pregnant women, women who are breast feeding, or women of child bearing potential who are not practicing an acceptable method of birth control (abstinence, birth control pill/patch, barrier with spermicidal jelly, IUD, etc.), as determined by the investigator. Acceptable contraception must be used during the entire study. |
Country | Name | City | State |
---|---|---|---|
United States | Wake Forest University Health Sciences Dermatology | Winston-Salem | North Carolina |
Lead Sponsor | Collaborator |
---|---|
Wake Forest University | Stiefel, a GSK Company |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Investigator Global Assessment | Investigator's Global Assessment Disease Severity is based on the following scale: 0 = completely clear: except for possible residual hyper pigmentation = almost clear: very significant clearance (about 90%) = Marked improvement: significant improvement (about 75%) = Moderate improvement: intermediate between slight and marked; representing about 50% improvements = Slight improvement: some improvement (about 25%); however, significant disease remaining = No change (moderate to severe disease) = Worse |
Disease severity assessed at baseline and 4 weeks, week 4 reported | |
Secondary | VAS of Pruritus | Subject's self assessment of itching based on a 100 mm visual analog scale with 0 being no itching and 10 being most severe itching | Assessed at baseline and 4 weeks, week 4 reported |
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