0.075% Capsaicin Lotion for the Treatment of Painful Diabetic Neuropathy

September 10, 2018 updated by: Assawin Chomjit, Thammasat University

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

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

Study Overview

Status

Completed

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

Enrollment (Actual)

42

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Pathumthani, Thailand, 12120
        • Thammasat University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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
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

This is where you will find people and organizations involved with this study.

Investigators

  • Study Chair: Kongkiat Kulkantrakorn, Professor, Thammasat University Hospital
  • Study Director: Pasiri Sithinamsuwan, Phramongkutklao college of medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 19, 2017

Primary Completion (Actual)

April 21, 2017

Study Completion (Actual)

January 31, 2018

Study Registration Dates

First Submitted

April 9, 2017

First Submitted That Met QC Criteria

April 12, 2017

First Posted (Actual)

April 13, 2017

Study Record Updates

Last Update Posted (Actual)

September 12, 2018

Last Update Submitted That Met QC Criteria

September 10, 2018

Last Verified

September 1, 2018

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

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

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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