0.075% Capsaicin Lotion for the Treatment of Painful Diabetic Neuropathy
NCT ID: NCT03113448
Last Updated: 2018-09-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
42 participants
INTERVENTIONAL
2017-01-19
2018-01-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
QUADRUPLE
Study Groups
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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
0.075% Capsaicin Lotion
To apply 3-4 times per day, every day until 8 weeks then stop
placebo
To apply 3-4 times per day, every day until 8 weeks then stop
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
0.075% Capsaicin Lotion
To apply 3-4 times per day, every day until 8 weeks then stop
placebo
To apply 3-4 times per day, every day until 8 weeks then stop
Interventions
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0.075% Capsaicin Lotion
To apply 3-4 times per day, every day until 8 weeks then stop
placebo
To apply 3-4 times per day, every day until 8 weeks then stop
Eligibility Criteria
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Inclusion Criteria
2. Clinical presentation of peripheral sensory such as burning pain
3. DN4 score from 4 points
4. Good consciousness to tell their score with informed consent agreement
5. No adding dosage of previous pain control medications at least 4 weeks
6. HbA1C 6.5-9.0%
Exclusion Criteria
2. Allergic history of Capsaicin
3. No intention to join the study with any reasons
4. 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
20 Years
ALL
No
Sponsors
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Thammasat University
OTHER
Responsible Party
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Assawin Chomjit
Director, Clinical research
Principal Investigators
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Kongkiat Kulkantrakorn, Professor
Role: STUDY_CHAIR
Thammasat University Hospital
Pasiri Sithinamsuwan
Role: STUDY_DIRECTOR
Phramongkutklao College of Medicine
Locations
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Thammasat University Hospital
Pathum Thani, , Thailand
Countries
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References
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Mangwani-Mordani S, Goodman CF, Galor A. Novel Treatments for Chronic Ocular Surface Pain. Cornea. 2023 Mar 1;42(3):261-271. doi: 10.1097/ICO.0000000000003193. Epub 2022 Dec 19.
Other Identifiers
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TCTR20170407001
Identifier Type: OTHER
Identifier Source: secondary_id
MTU-EC-IM-5-195/59
Identifier Type: -
Identifier Source: org_study_id
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