Ignite Creation Date:
2024-05-06 @ 7:10 AM
Last Modification Date:
2024-10-26 @ 11:45 AM
Study NCT ID:
NCT02484170
Status:
COMPLETED
Last Update Posted:
2018-10-23
First Post:
2015-06-13
Brief Title:
Mannitol Cream for Post Herpetic Neuralgia
Sponsor:
University of British Columbia
Organization:
University of British Columbia
Study Overview
Official Title:
Mannitol Cream in the Treatment of Post-herpeticNeuralgiaa Randomized Placebo-Controlled Crossover Pilot Study
Status:
COMPLETED
Status Verified Date:
2018-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MannitolPHN
Brief Summary:
30 mannitol cream has shown its ability to reduce the activation of the Capsaicin TRPV1 Transient Receptor Potential Vanilloid 1 receptor a likely cause of the pain of post-herpetic neuralgia PHN This randomized placebo-controlled crossover study compares PHN pain one week before for one week on the randomly assigned mannitol versus placebo cream and after a three day washout for one week on the other cream Following this crossover study participants receive mannitol cream for three months Pain levels will be checked to assess whether continued use of this cream significantly reduces the pain levels associated with PHN If pain persists beyond 3 months participants will be offered mannitol and menthol cream for one month following which their pain levels will be checked
Detailed Description:
Pain levels 0 to 10 Numerical Rating Scale NRS medication and alcohol intake will be checked daily for one week prior to randomization in 20 participants with post herpetic neuralgia lasting more than three months Following this 10 will be randomized to apply 30 mannitol in vehicle cream and 10 to apply vehicle cream alone for one week during which daily pain levels and use of medication and alcohol will be measured together with the mode of application rubbing in or applying it to cling wrap then applying the cream coated cling wrap to the skin in cases of severe allodynia After a three day washout period they will be given the cream they did not receive previously for one week The same variables will be recorded daily The data collected in the first 24 days will be used to generate a power analysis Following this all subjects will receive the 30 mannitol cream to apply for three months Their pain levels medication intake and method of application will be measured once a month for three months T-tests will compare the pain levels for mannitol and placebo users before and after one week of the use of each cream to see if the mannitol cream provides better short term pain relief than placebo Repeated measures ANOVA Analysis Of VAriance will compare pain levels before using the mannitol cream and monthly for three months to assess the long-term effects of mannitol cream Variables collected at each visit which will not be used for statistical purposes in the current very small pilot project but may be used in a later study include application method effect and side effects of the cream medication and alcohol use PHQ - 9 Personal Health Questionnaire 9 questions and questions from the brief pain inventory score At three months a satisfaction score will be added to the database If pain persists beyond 3 months participants will be offered mannitol and menthol cream for one month following which their pain levels PHQ - 9 and brief pain inventory scores will be checked
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None