Neuralgia, PostherpeticPhase 1/2MannitolPHNNCT02484170
Mannitol Cream for Post Herpetic Neuralgia
A Phase 1/2 study testing Mannitol cream in people with Neuralgia, Postherpetic, run by University of British Columbia at 1 site in Canada.
Trial 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). Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Neuralgia, Postherpetic
- What is being tested?
- Mannitol cream
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteCanada
- Study dates
- 30 Sep 2015to 30 Apr 2017
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- - 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.
- 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..
- 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.
Who cannot join
- 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
- -
Trial locations and contacts
1 site in 1 country.
Canada1 site
Dr. Helene Bertrand Inc.
North Vancouver, British Columbia, V7M 2K2
About this study
Official title: Mannitol Cream in the Treatment of Post-herpeticNeuralgia;a Randomized Placebo-Controlled Crossover Pilot Study
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.
Read the 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.
- Conditions
- Neuralgia, Postherpetic
- Being tested
- Mannitol cream, Placebo
- Keywords
- Mannitol, cream, neuropathic pain
- Medical subject headings
- Neuralgia, Postherpetic, Neuralgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mannitol creamDrug
Also called Mannitol in vehicle cream, QR cream
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
PlaceboDrug
Also called Vehicle cream
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Mannitol cream; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Number of pills taken for pain in one day. Will decrease as the pain intensity decreases. Write the number of tablets that you took: 1. Tylenol/acetaminophen______, 2. Anti-inflammatory medication like Advil/ibuprofen, naproxen, diclofenac, Voltaren, Aleve______, 3. Tylenol or ASA (acetylsalicylic acid) plus narcotic like Tylenol 3, or 292 or Tramacet (acetaminophen/tramadol) ______, 4. Narcotic like morphine, hydromorphone/dilaudid, fentanyl, Demerol, tramadol______, 5. Cannabis, marijuana, or pot______, The total in each category will be added to calculate the total number of tablets taken in 24 hours.
Measured: Before each cream is first applied, 7 days later, and for mannitol cream 1,2 and 3,months
Change in Alcohol intake
Number of alcoholic drinks in one day. May decrease as the pain intensity decreases. Write down the total number of alcoholic drinks you had in the last 24 hours:how many glasses of wine ______ glasses of hard liquor______ bottles of beer______. The total number of glasses will be recorded.
Measured: 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
The total from the following questions will be recorded to measure how much their pain is interfering with their lives: Circle one number. In the last 24 hours, how much has your pain interfered with your:
General activity:, Mood: Walking ability: Normal work: (includes both work outside the home and housework) Relations with other people: Sleep: Enjoyment of life: Each of these will be scored as follows: does not interfere 0 1 2 3 4 5 6 7 8 9 10 completely interferes. The scores added up. This sum should decrease as the pain decreases.
Measured: 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
Patients will fill the PHQ - 9 score. http://phqscreeners.com/pdfs/02_PHQ-9/English.pdf The sum of the answers from this questionnaire, which is used to measure the degree of depression, may decrease as the pain intensity decreases.
Measured: Before each cream is first applied, 7 days later, and for mannitol cream 1,2 and 3 months
Change in Method of cream application
Patients will describe whether they use cling wrap (4), gentle applicator (3) or rubbing in gently (2) or vigourous rubbing (1)
Measured: when each cream is first applied, 7 days later, and for mannitol cream 1,2 and 3 months
Change in effect and side effects of the cream
How many times did you apply the cream today?_______ Circle one number. How bad was your pain?.. Before you applied the cream? NRS 0-10 1hour after you applied the cream? NRS 0-10 Did the cream relieve your pain? No □ if Yes □ in how many minutes?____ For how many hours was your pain relieved?____ Did you experience a side effect from the cream? No □ if Yes □ What was it?_________________ Any comments?_______________________
Measured: Daily for the 14 days, of the crossover study, then at 1,2 and 3 months
Satisfaction from cream use
How satisfied were you with the use of this cream? Not at all satisfied 0 1 2 3 4 5 6 7 8 9 10 extremely satisfied
Measured: Three months after use of mannitol cream was started.
Change in pain score from mannitol cream use to mannitol and menthol cream use
Maximum pain score after 3 months of mannitol cream use compared to maximum pain score after one month of mannitol and menthol cream use
Measured: 1st measurement Three months after use of mannitol cream was started 2nd measurement one month after mannitol and menthol cream started
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2015 (estimated)
- Study start30 Sep 2015
- Primary completion29 Apr 2016
- Study completion30 Apr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Neuralgia, PostherpeticStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- 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.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Helene Bertrand, University of British Columbia
- Investigators
- Helene Bertrand, MD, CM, CCFP, Principal investigator, University of British Columbia, Department of family practice
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02484170
- Sponsor's protocol ID
- H15-01260
- Acronym
- MannitolPHN
- Status last verified
- Oct 2018
- First submitted
- 13 Jun 2015
- Last updated
- 23 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
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 Nov;7(11):1111-1117. doi: 10.1016/j.pmrj.2015.05.002. Epub 2015 May 12.
PubMed 25978942Gilron 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.
PubMed 25841257Shannon 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.
PubMed 22610112Szolcsanyi 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.
PubMed 23068431
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mannitol Cream in the Treatment of Post-herpeticNeuralgia;a Randomized Placebo-Controlled Crossover Pilot Study
- ClinicalTrials.gov ID
- NCT02484170
- Acronym / sponsor ID
- MannitolPHN / H15-01260
- Conditions
- Neuralgia, Postherpetic
- Keywords
- Mannitol, cream, neuropathic pain
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Study start
- 30 Sep 2015
- Primary completion
- 29 Apr 2016 (actual)
- Study completion
- 30 Apr 2017 (actual)
- First posted
- 29 Jun 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| mannitol in vehicle cream /vehicle cream | Active comparator | Drug: Mannitol cream, Drug: Placeboone 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. |
| vehicle cream /mannitol in vehicle cream | Active comparator | Drug: Mannitol cream, Drug: Placeboone 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. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- - 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.
- 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..
- 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.
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mannitol creamAlso: Mannitol in vehicle cream, QR creamApply 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 | Drug | mannitol in vehicle cream /vehicle cream, vehicle cream /mannitol in vehicle cream |
| PlaceboAlso: Vehicle creamApply 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 | Drug | mannitol in vehicle cream /vehicle cream, vehicle cream /mannitol in vehicle cream |
Primary outcome
Change in worst NRS (Numerical Rating Scale) pain score
Time frame: Before each cream is first applied, 7 days later, and for mannitol cream 1,2 and 3 months
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
Change in average NRS (Numerical Rating Scale) pain score
Time frame: Before each cream is first applied, 7 days later, and for mannitol cream 1,2 and 3 months
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
8 secondary outcomes
Change in Pain medication intake
Time frame: Before each cream is first applied, 7 days later, and for mannitol cream 1,2 and 3,months
Change in Alcohol intake
Time frame: 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
Time frame: 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
Time frame: Before each cream is first applied, 7 days later, and for mannitol cream 1,2 and 3 months
Change in Method of cream application
Time frame: when each cream is first applied, 7 days later, and for mannitol cream 1,2 and 3 months
Change in effect and side effects of the cream
Time frame: Daily for the 14 days, of the crossover study, then at 1,2 and 3 months
Satisfaction from cream use
Time frame: Three months after use of mannitol cream was started.
Change in pain score from mannitol cream use to mannitol and menthol cream use
Time frame: 1st measurement Three months after use of mannitol cream was started 2nd measurement one month after mannitol and menthol cream started
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2018.
- Background: PubMed 25978942Bertrand 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.
- Background: PubMed 25841257Gilron 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.
- Background: PubMed 22610112Shannon 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.
- Background: PubMed 23068431Szolcsanyi 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Helene Bertrand, MD, CM, CCFP principal investigator
University of British Columbia, Department of family practice
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Mannitol cream in people with Neuralgia, Postherpetic, run by University of British Columbia at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in worst NRS (Numerical Rating Scale) pain score (time frame: Before each cream is first applied, 7 days later, and for mannitol cream 1,2 and 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02484170, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2018.