Mannitol Cream for Post Herpetic Neuralgia

NCT02484170 | Completed Phase 1

• 1 other identifier: H15-01260
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Neuralgia, Postherpetic

Keywords

Mannitol; cream; neuropathic pain

Outcome Measures

Primary Outcomes (2)

• Change in worst NRS (Numerical Rating Scale) pain score

  In the last 24 hours, how bad was your pain at its worst? No pain 0 1 2 3 4 5 6 7 8 9 10 Worst pain imaginable

  Before each cream is first applied, 7 days later, and for mannitol cream 1,2 and 3 months

• Change in average NRS (Numerical Rating Scale) pain score

  In the last 24 hours, how bad was your pain on average? No pain 0 1 2 3 4 5 6 7 8 9 10 Worst pain imaginable

  Before each cream is first applied, 7 days later, and for mannitol cream 1,2 and 3 months

Secondary Outcomes (8)

• Change in Pain medication intake

  Before each cream is first applied, 7 days later, and for mannitol cream 1,2 and 3,months

• Change in Alcohol intake

  Before each cream is first applied, 7 days later, and for mannitol cream 1,2 and 3 months

• Change in questions from the brief pain inventory score

  Before each cream is first applied, 7 days later, and for mannitol cream 1,2 and 3 months

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

  Before each cream is first applied, 7 days later, and for mannitol cream 1,2 and 3 months

• Change in Method of cream application

  when each cream is first applied, 7 days later, and for mannitol cream 1,2 and 3 months

Study Arms (2)

mannitol in vehicle cream /vehicle cream

ACTIVE COMPARATOR

one week on the mannitol cream (mannitol 30% in vehicle cream), a 3 day washout period, and one week on the placebo cream (vehicle cream alone). To be applied over the painful area as needed for pain. Usual frequency is 2 to 3 times daily.

Drug: Mannitol cream; Drug: Placebo

vehicle cream /mannitol in vehicle cream

ACTIVE COMPARATOR

one week on the placebo cream (vehicle cream alone), a 3 day washout period, and one week on the mannitol cream (mannitol 30% in vehicle cream).To be applied over the painful area as needed for pain. Usual frequency is unknown.

Drug: Mannitol cream; Drug: Placebo

Interventions

Mannitol cream DRUG

Apply to area of postherpetic neuralgia pain as needed for pain control. Usual frequency is 2 to 3 times per day.For crossover study, will be applied for 7 days. For observational study, will be applied up to 3 months

Also known as: Mannitol in vehicle cream, QR cream

mannitol in vehicle cream /vehicle cream; vehicle cream /mannitol in vehicle cream

Placebo DRUG

Apply to area of postherpetic neuralgia pain as needed for pain control.Usual frequency is unknown. For crossover study, will be applied for 7 days. Will not be used after crossover study

Also known as: Vehicle cream

mannitol in vehicle cream /vehicle cream; vehicle cream /mannitol in vehicle cream

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- Suffering from post-herpetic neuralgia on the trunk or the extremities for at least three months.
• \- Maximum daily pain score greater than or equal to 5/10.
• \- Having failed to improve with at least one neuropathic pain medication.
• 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..
• Preferably have access to someone who can apply cream to their back if they have pain in the back and cannot reach the area.
• If that is not possible, ability to apply the cream to their own back, using an applicator which will be supplied.

You may not qualify if:

• Allergies to any of the ingredients of the cream
• Open lesions or abrasions on the skin where the cream will be applied
• Using corticosteroids
• Unwilling to stop using other topical products (creams or patches) for the treatment of post-herpetic neuralgia
• Pregnant, breast-feeding or not using birth control
• Suffering from severe chronic pain from a cause other than post-herpetic neuralgia

Sponsors & Collaborators

• University of British Columbia: lead

Study Sites (1)

Dr. Helene Bertrand Inc.

North Vancouver, British Columbia, V7M 2K2, Canada

Location

Related Publications (4)

• 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 Nov;7(11):1111-1117. doi: 10.1016/j.pmrj.2015.05.002. Epub 2015 May 12.

  PMID: 25978942 BACKGROUND

• 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.

  PMID: 25841257 BACKGROUND

• 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.

  PMID: 22610112 BACKGROUND

• Szolcsanyi J, Sandor 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.

  PMID: 23068431 BACKGROUND

MeSH Terms

Conditions

Neuralgia, Postherpetic; Neuralgia

Interventions

Mannitol

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Sugar Alcohols; Alcohols; Organic Chemicals; Carbohydrates

Study Officials

• Helene Bertrand, MD, CM, CCFP

  University of British Columbia, Department of family practice

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, CCFP, Clinical instructor, Department of family practice University of British Columbia

Model Details: 1 week observation, one week cream A assigned, 3 day crossover, one week of cream B assigned. After the crossover study, 3 months of mannitol cream assigned.

Study Record Dates

• First Submitted: June 13, 2015
• First Posted: June 29, 2015
• Study Start: September 30, 2015
• Primary Completion: April 29, 2016
• Study Completion: April 30, 2017
• Last Updated: October 23, 2018

Record last verified: 2018-10

Locations

CA (1)