Mannitol Cream for Post Herpetic Neuralgia

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-09-30

Study Completion Date

2017-04-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Double-blind Trial of Mannitol Cream to Block the Effect of Capsaicin Cream

NCT01963910

Pain

COMPLETED NA

Topical Menthol +/- Mannitol for Painful Diabetic Peripheral Neuropathy

NCT02728687

Diabetic Peripheral Neuropathy

COMPLETED PHASE1/PHASE2

A Comparison of EpiCept™ NP-1 Topical Cream vs. Oral Gabapentin in Postherpetic Neuralgia (PHN)

NCT00475904

Post Herpetic Neuralgia PHN Neuropathy +1 more

COMPLETED PHASE2

3VM1001 Cream for the Treatment of Pain Associated With Post Herpetic Neuralgia (PHN)

NCT03421613

Treatment of PHN

COMPLETED EARLY_PHASE1

Study of NGX-4010 With the Use of Open Label Lidocaine (2.5%)/Prilocaine (2.5%) Cream for the Treatment of Postherpetic Neuralgia (PHN)

NCT00916942

Postherpetic Neuralgia

COMPLETED PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Neuralgia, Postherpetic

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

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.

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

mannitol in vehicle cream /vehicle cream

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.

Group Type ACTIVE_COMPARATOR

Mannitol cream

Intervention Type 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

Placebo

Intervention Type 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

vehicle cream /mannitol in vehicle cream

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.

Group Type ACTIVE_COMPARATOR

Mannitol cream

Intervention Type 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

Placebo

Intervention Type 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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Mannitol 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

Intervention Type DRUG

Placebo

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

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Mannitol in vehicle cream QR cream Vehicle cream

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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..

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
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, breast-feeding or not using birth control
6. Suffering from severe chronic pain from a cause other than post-herpetic neuralgia

\-

Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No