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Sponsored by: |
Wake Forest University |
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Information provided by: | Wake Forest University |
ClinicalTrials.gov Identifier: | NCT00693654 |
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.
Condition | Intervention | Phase |
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Pruritis |
Drug: Sarna Drug: Cetaphil |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Efficacy Study |
Official Title: | A Controlled Comparative Study of the Efficacy of SARNA Sensitive Lotion for Treatment of Uremic Pruritus in Adult Hemodialysis Patients |
Estimated Enrollment: | 30 |
Study Start Date: | November 2006 |
Estimated Study Completion Date: | October 2008 |
Primary Completion Date: | November 2006 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
active medicated lotion (Sarna)
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Drug: Sarna
Active Ingredient: Pramoxine Hydrochloride Inactive ingredients:Benzyl Alcohol, Carbomer 940, Cetyl Alcohol, Dimethicone, Glyceryl Stearate (&) PEG-100 Stearate, Isopropyl Myristate, Petrolatum, PEG 8 Stearate, Purified Water, Stearic Acid, Sodium Hydroxide
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2: Placebo Comparator
Placebo lotion (Cetaphil)
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Drug: Cetaphil
Purified Water, Glycerin, Hydrogenated Polyisobutene, Cetearyl Alcohol, Ceteareth 20, Macadamia Nut Oil, Dimethicone, Tocopheryl Acetate, Stearoxytrimethylsilane, Stearyl Alcohol, Panthenol, Farnesol, Benzyl Alcohol, Phenoxyethanol, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Sodium Hydroxide, Citric Acid
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Ages Eligible for Study: | 18 Years to 70 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, North Carolina | |
Wake Forest University Health Sciences Dermatology | |
Winston Salem, North Carolina, United States, 27157 |
Principal Investigator: | Alan Fleischer, MD | Wake Forest University |
Responsible Party: | Wake Forest University Health Sciences ( Alan Fleischer, MD ) |
Study ID Numbers: | 00000656, 31648 |
Study First Received: | June 5, 2008 |
Last Updated: | June 11, 2008 |
ClinicalTrials.gov Identifier: | NCT00693654 |
Health Authority: | United States: Institutional Review Board |
Uremic Pruritis |
Tocopherols Pruritus Tocopherol acetate Vitamin E Glycerol |
Citric Acid Petrolatum Ethanol Alpha-Tocopherol |