0.075% Capsaicin Lotion for the Treatment of Painful Diabetic Neuropathy

Study Overview
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Brief Summary
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To study that 0.075% capsaicin lotion is safe, well tolerated and provide significant pain relief in patients with PDN compared with placebo lotion as a randomized, double- Blind, crossover, placebo-controlled trial

Detailed Description
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Neuropathy is one of the most common complications in both type 1 and type 2 diabetes mellitus. The most common symptom is a symmetrical, chronic, axonal, length-dependent sensorimotor polyneuropathy. Topical capsaicin formulations are widely used to manage pain. Low-concentration creams, lotions, and patches intended for daily skin application have been available in most countries since the early 1980s. We study 0.075% capsaicin lotion is safe, well tolerated and provide significant pain relief in patients with PDN compared with placebo lotion as a randomized, double- Blind, crossover, placebo-controlled trial for 20 weeks throughout the study in 42 participants. All participants are provided both 0.075% capsaicin lotion and placebo lotion. Each agent will be applied for 8 weeks then stop for 4 weeks, after that another agent will be used for 8 weeks. We keep following up all of them by calling and appointment to get information in effectiveness and adverse effect at 0,2,4,8,12,14,16,20 week, respectively.

Official Title
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0.075% Capsaicin Lotion for the Treatment of Painful Diabetic Neuropathy: A Randomized, Double- Blind, Crossover, Placebo-Controlled Trial

Conditions
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Peripheral Diabetic Neuropathy

Intervention / Treatment
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* Drug: 0.075% Capsaicin Lotion
* Drug: placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: DM type 2 over 1 year Clinical presentation of peripheral sensory such as burning pain DN4 score from 4 points Good consciousness to tell their score with informed consent agreement No adding dosage of previous pain control medications at least 4 weeks HbA1C 6.5-9.0% Exclusion Criteria: Improper application site of skin for topical drugs such as abrasion wound. Allergic history of Capsaicin No intention to join the study with any reasons Other previous medications used that effect to peripheral neuropathy such as Carboplatin, Cisplatin, Colchicine, Dapsone, Etoposide, Ethambutol, Indomethacin, Isoniazid, Lithium, Metronidazole, Phenytoin, Pyridoxine, Statins, Stavudine (d4T) or conditions worsening peripheral nerves following that poor nutrition, kidney failure, chronic alcoholism, vitamin deficiency, Hypothyroidism

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: Randomized controlled trial, double blind
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 0.075% Capsaicin Lotion<br>0.075% Capsaicin Lotion is used for application at skin area involved with symptomatic neuropathic pain (both feet or/and hands), 3-4 times a day, everyday for 8 weeks then stop | Drug: 0.075% Capsaicin Lotion<br>* To apply 3-4 times per day, every day until 8 weeks then stop<br>Drug: placebo<br>* To apply 3-4 times per day, every day until 8 weeks then stop<br>|
| Placebo Comparator: Placebo Lotion<br>Placebo Lotion is used for application at skin area involved with symptomatic neuropathic pain (both feet or/and hands), 3-4 times a day, everyday for 8 weeks then stop | Drug: 0.075% Capsaicin Lotion<br>* To apply 3-4 times per day, every day until 8 weeks then stop<br>Drug: placebo<br>* To apply 3-4 times per day, every day until 8 weeks then stop<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual analog scale (0-100 mm.) | scale | 20 week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Short-form McGill Pain Questionnaire(SF-MPQ) | scale | 20 week | 
| Neuropathic Pain Scale (NPS) | scale | 20 week | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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capsaicin, neuropathic pain, diabetic neuropathy, topical lotion