Comparative Study of the Efficacy of SARNA Sensitive Lotion for Treatment of Uremic Itch in Adult Hemodialysis Patients
Status: | Completed |
---|---|
Conditions: | Allergy |
Therapuetic Areas: | Otolaryngology |
Healthy: | No |
Age Range: | 18 - 70 |
Updated: | 9/12/2018 |
Start Date: | November 2006 |
End Date: | October 2008 |
A Controlled Comparative Study of the Efficacy of SARNA Sensitive Lotion for Treatment of Uremic Pruritus in Adult Hemodialysis Patients
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.
the treatment of uremic pruritus in adult hemodialysis patients in a double-blind Controlled
comparative trial.
This was a 4-week, randomized, double-blind, controlled study. Fourteen subjects received
treatment lotion (1% pramoxine HCl) and the remaining 14 received a bland emollient (Cetaphil
lotion). A target lesion limited to one anatomic site, excluding face and genitals, was
selected at baseline. Each subject was instructed to apply lotion twice daily to all affected
areas of pruritus for four weeks. The use of any other topical or systemic medication to
treat uremic pruritus was not permitted while participating in the study. Subjects were
clinically evaluated for erythema, xerosis, lichenification and overall severity at baseline,
week 1, and week 4 (end of study)
treatment lotion (1% pramoxine HCl) and the remaining 14 received a bland emollient (Cetaphil
lotion). A target lesion limited to one anatomic site, excluding face and genitals, was
selected at baseline. Each subject was instructed to apply lotion twice daily to all affected
areas of pruritus for four weeks. The use of any other topical or systemic medication to
treat uremic pruritus was not permitted while participating in the study. Subjects were
clinically evaluated for erythema, xerosis, lichenification and overall severity at baseline,
week 1, and week 4 (end of study)
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.
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