Trial Outcomes & Findings for Comparative Study of the Efficacy of SARNA Sensitive Lotion for Treatment of Uremic Itch in Adult Hemodialysis Patients (NCT NCT00693654)

Results Overview

Investigator's Global Assessment Disease Severity is based on the following scale: 0 = completely clear: except for possible residual hyper pigmentation 1. = almost clear: very significant clearance (about 90%) 2. = Marked improvement: significant improvement (about 75%) 3. = Moderate improvement: intermediate between slight and marked; representing about 50% improvements 4. = Slight improvement: some improvement (about 25%); however, significant disease remaining 5. = No change (moderate to severe disease) 6. = Worse

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

28 participants

Primary outcome timeframe

Disease severity assessed at baseline and 4 weeks, week 4 reported

Results posted on

2018-09-10

Participant Flow

Subjects were recruited from 11/6/06 to 11/27/06 from the Salem Kidney Center in Winston Salem, NC.

Subjects were randomized so that half received Sarna lotion to be applied twice daily to all areas of pruritus, the other half applied placebo lotion twice daily to areas of pruritus.

Participant milestones

Participant milestones
Measure	Pramoxine Lotion Active Medicated Pramoxine Lotion (Sarna) applied topically twice daily to areas of pruritus	Placebo Cetaphil Lotion Placebo lotion (Cetaphil) applied twice daily to areas of pruritus
Overall Study STARTED	14	14
Overall Study COMPLETED	14	14
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Comparative Study of the Efficacy of SARNA Sensitive Lotion for Treatment of Uremic Itch in Adult Hemodialysis Patients

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Active n=14 Participants Active Medicated Lotion (Sarna)	Placebo n=14 Participants Placebo lotion (Cetaphil)	Total n=28 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	14 Participants n=5 Participants	14 Participants n=7 Participants	28 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	48.9 years STANDARD_DEVIATION 13.6 • n=5 Participants	58.0 years STANDARD_DEVIATION 7.54 • n=7 Participants	53.5 years STANDARD_DEVIATION 7.54 • n=5 Participants
Sex: Female, Male Female	7 Participants n=5 Participants	7 Participants n=7 Participants	14 Participants n=5 Participants
Sex: Female, Male Male	7 Participants n=5 Participants	7 Participants n=7 Participants	14 Participants n=5 Participants
Region of Enrollment United States	14 participants n=5 Participants	14 participants n=7 Participants	28 participants n=5 Participants

PRIMARY outcome

Timeframe: Disease severity assessed at baseline and 4 weeks, week 4 reported

Investigator's Global Assessment Disease Severity is based on the following scale: 0 = completely clear: except for possible residual hyper pigmentation 1. = almost clear: very significant clearance (about 90%) 2. = Marked improvement: significant improvement (about 75%) 3. = Moderate improvement: intermediate between slight and marked; representing about 50% improvements 4. = Slight improvement: some improvement (about 25%); however, significant disease remaining 5. = No change (moderate to severe disease) 6. = Worse

Outcome measures

Outcome measures
Measure	Active n=14 Participants Active Medicated Pramoxine Lotion (Sarna)	Placebo n=14 Participants Placebo lotion (Cetaphil)
Investigator Global Assessment	2.63 units on a scale Standard Deviation 0.37	2.32 units on a scale Standard Deviation 0.36

SECONDARY outcome

Timeframe: Assessed at baseline and 4 weeks, week 4 reported

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

Outcome measures

Outcome measures
Measure	Active n=14 Participants Active Medicated Pramoxine Lotion (Sarna)	Placebo n=14 Participants Placebo lotion (Cetaphil)
VAS of Pruritus	2.73 units on a scale Standard Deviation 0.12	2.82 units on a scale Standard Deviation 0.12

Adverse Events

Active

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Alan Fleischer, Jr., MD

Wake Forest University Health Sciences

Phone: 336-716-7753

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place