0.075% Capsaicin Lotion for the Treatment of Painful Diabetic Neuropathy

Peripheral Diabetic Neuropathy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03113448
• Other study ID #: MTU-EC-IM-5-195/59
• Secondary ID: TCTR20170407001
• Status: Completed
• Phase: Phase 3
• Start date: January 19, 2017
• Est. completion date: January 31, 2018

Study information

• Verified date: September 2018
• Source: Thammasat University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: January 31, 2018
• Est. primary completion date: April 21, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetic Neuropathies
• Peripheral Diabetic Neuropathy
• Peripheral Nervous System Diseases

Intervention

Drug:
• 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

Locations

Country	Name	City	State
Thailand	Thammasat University Hospital	Pathumthani

Sponsors (1)

Lead Sponsor	Collaborator
Thammasat University

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visual analog scale (0-100 mm.)	scale	20 week
Secondary	Short-form McGill Pain Questionnaire(SF-MPQ)	scale	20 week
Secondary	Neuropathic Pain Scale (NPS)	scale	20 week