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0.075% Capsaicin Lotion for the Treatment of Painful Diabetic Neuropathy

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ClinicalTrials.gov Identifier: NCT03113448
Recruitment Status : Completed
First Posted : April 13, 2017
Last Update Posted : September 12, 2018
Sponsor:
Information provided by (Responsible Party):
Assawin Chomjit, Thammasat University

Brief Summary:
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

Condition or disease Intervention/treatment Phase
Peripheral Diabetic Neuropathy Drug: 0.075% Capsaicin Lotion Drug: placebo Phase 3

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 : Interventional  (Clinical Trial)
Actual Enrollment : 42 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: Randomized controlled trial, double blind
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 0.075% Capsaicin Lotion for the Treatment of Painful Diabetic Neuropathy: A Randomized, Double- Blind, Crossover, Placebo-Controlled Trial
Actual Study Start Date : January 19, 2017
Actual Primary Completion Date : April 21, 2017
Actual Study Completion Date : January 31, 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Capsaicin

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
Drug: 0.075% Capsaicin Lotion
To apply 3-4 times per day, every day until 8 weeks then stop

Drug: placebo
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
Drug: 0.075% Capsaicin Lotion
To apply 3-4 times per day, every day until 8 weeks then stop

Drug: placebo
To apply 3-4 times per day, every day until 8 weeks then stop




Primary Outcome Measures :
  1. Visual analog scale (0-100 mm.) [ Time Frame: 20 week ]
    scale


Secondary Outcome Measures :
  1. Short-form McGill Pain Questionnaire(SF-MPQ) [ Time Frame: 20 week ]
    scale

  2. Neuropathic Pain Scale (NPS) [ Time Frame: 20 week ]
    scale



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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. DM type 2 over 1 year
  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:

  1. Improper application site of skin for topical drugs such as abrasion wound.
  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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03113448


Locations
Thailand
Thammasat University Hospital
Pathumthani, Thailand, 12120
Sponsors and Collaborators
Thammasat University
Investigators
Study Chair: Kongkiat Kulkantrakorn, Professor Thammasat University Hospital
Study Director: Pasiri Sithinamsuwan Phramongkutklao College of Medicine

Responsible Party: Assawin Chomjit, Director, Clinical research, Thammasat University
ClinicalTrials.gov Identifier: NCT03113448     History of Changes
Other Study ID Numbers: MTU-EC-IM-5-195/59
TCTR20170407001 ( Other Identifier: Thai Clinical Trials Registry )
First Posted: April 13, 2017    Key Record Dates
Last Update Posted: September 12, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Assawin Chomjit, Thammasat University:
capsaicin
neuropathic pain
diabetic neuropathy
topical lotion

Additional relevant MeSH terms:
Diabetic Neuropathies
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Capsaicin
Antipruritics
Dermatologic Agents
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs