- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03113448
0.075% Capsaicin Lotion for the Treatment of Painful Diabetic Neuropathy
0.075% Capsaicin Lotion for the Treatment of Painful Diabetic Neuropathy: A Randomized, Double- Blind, Crossover, Placebo-Controlled Trial
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
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Pathumthani, Thailand, 12120
- Thammasat University Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: 0.075% Capsaicin Lotion
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
|
To apply 3-4 times per day, every day until 8 weeks then stop
To apply 3-4 times per day, every day until 8 weeks then stop
|
Placebo Comparator: Placebo Lotion
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
|
To apply 3-4 times per day, every day until 8 weeks then stop
To apply 3-4 times per day, every day until 8 weeks then stop
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Visual analog scale (0-100 mm.)
Time Frame: 20 week
|
scale
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20 week
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Short-form McGill Pain Questionnaire(SF-MPQ)
Time Frame: 20 week
|
scale
|
20 week
|
Neuropathic Pain Scale (NPS)
Time Frame: 20 week
|
scale
|
20 week
|
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Kongkiat Kulkantrakorn, Professor, Thammasat University Hospital
- Study Director: Pasiri Sithinamsuwan, Phramongkutklao college of medicine
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Nervous System Diseases
- Endocrine System Diseases
- Diabetes Complications
- Diabetes Mellitus
- Neuromuscular Diseases
- Peripheral Nervous System Diseases
- Diabetic Neuropathies
- Physiological Effects of Drugs
- Peripheral Nervous System Agents
- Sensory System Agents
- Dermatologic Agents
- Antipruritics
- Capsaicin
Other Study ID Numbers
- MTU-EC-IM-5-195/59
- TCTR20170407001 (Other Identifier: Thai Clinical Trials Registry)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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October 6 UniversityCompletedDiabetic Neuropathy PeripheralEgypt
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CSPC ZhongQi Pharmaceutical Technology Co., Ltd.UnknownDiabetic Peripheral Neuropathy
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Fengmei LianPeking Union Medical College Hospital; Huashan Hospital; Chengdu University of... and other collaboratorsUnknownDiabetic Peripheral Neuropathy Type 2China
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