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Mannitol Cream for Post Herpetic Neuralgia

Information source: University of British Columbia
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Neuralgia, Postherpetic

Intervention: Mannitol cream (Drug); Placebo (Drug)

Phase: Phase 1/Phase 2

Status: Not yet recruiting

Sponsored by: University of British Columbia

Official(s) and/or principal investigator(s):
Helene Bertrand, MD, CM, CCFP, Principal Investigator, Affiliation: University of British Columbia, Department of family practice

Overall contact:
Helene Bertrand, MD, CM, CCFP, Phone: 604-985-5381, Email: dr.hbertrand@gmail.com


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, and ,on request, for a further 9 months. Pain levels and pain area will be checked to assess whether continued use of this cream significantly reduces the pain levels and the area of pain associated with PHN.

Clinical Details

Official title: Mannitol Cream in the Treatment of Post-herpeticNeuralgia;a Randomized Placebo-Controlled Crossover Pilot Study

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Change in average NRS (Numerical Rating Scale) score

Secondary outcome:

Change in Pain medication intake

Change in Alcohol intake

Change in questions from the brief pain inventory score

Change in PHQ-9 (Personal health questionnaire, 9 questions) Score

Change in Method of cream application

Change in area of postherpetic neuralgia pain

Change in effect and side effects of the cream

Satisfaction from cream use

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 12 participants with post herpetic neuralgia, lasting more than three months. Following this 6 will be randomized to apply 30% mannitol in vehicle cream and 6 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, area of pain, medication intake and method of application will be measured once a month for three months. T-tests will compare the pain levels and pain area 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 and area of pain 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 one year, a satisfaction score will be added to the database.


Minimum age: 19 Years. Maximum age: N/A. Gender(s): Both.


Inclusion Criteria

1. - Suffering from post-herpetic neuralgia on the trunk or the extremities for at least

three months.

2. - Maximum daily pain score greater than or equal to 5/10.

3. - Having failed to improve with at least one neuropathic pain medication.

4- Able and willing to fill a fluid survey NRS pain scale and a medication intake questionnaire daily, preferably online but on paper, if unable, for the first 24 days of the study, then once a month for three months, then at six months and one year.

5 - Preferably have access to someone who can apply cream to their back if they have pain

in the back and cannot reach the area.

6 - If that is not possible, ability to apply the cream to their own back, using an

applicator which will be supplied. Exclusion Criteria: 1. Allergies to any of the ingredients of the cream, or eye liner 2. Open lesions or abrasions on the skin where the cream will be applied 3. Using corticosteroids 4. Unwilling to stop using other topical products (creams or patches) for the treatment of post-herpetic neuralgia 5. Pregnant 6. Suffering from severe chronic pain from a cause other than post-herpetic neuralgia


Locations and Contacts

Helene Bertrand, MD, CM, CCFP, Phone: 604-985-5381, Email: dr.hbertrand@gmail.com

Additional Information

Related publications:

Bertrand H, Kyriazis M, Reeves KD, Lyftogt J, Rabago D. Topical Mannitol Reduces Capsaicin-Induced Pain: Results of a Pilot-Level, Double-Blind, Randomized Controlled Trial. PM R. 2015 May 12. pii: S1934-1482(15)00230-0. doi: 10.1016/j.pmrj.2015.05.002. [Epub ahead of print]

Gilron I, Baron R, Jensen T. Neuropathic pain: principles of diagnosis and treatment. Mayo Clin Proc. 2015 Apr;90(4):532-45. doi: 10.1016/j.mayocp.2015.01.018. Review.

Shannon HJ, Anderson J, Damle JS. Evidence for interventional procedures as an adjunct therapy in the treatment of shingles pain. Adv Skin Wound Care. 2012 Jun;25(6):276-84; quiz 285-6. doi: 10.1097/01.ASW.0000415345.22307.f3. Review.

Szolcsányi J, Sándor Z. Multisteric TRPV1 nocisensor: a target for analgesics. Trends Pharmacol Sci. 2012 Dec;33(12):646-55. doi: 10.1016/j.tips.2012.09.002. Epub 2012 Oct 12. Review.

Starting date: September 2015
Last updated: June 24, 2015

Page last updated: August 23, 2015

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