0.075% Capsaicin Lotion for the Treatment of Painful Diabetic Neuropathy

Phase 3

Completed

• Conditions: Peripheral Diabetic Neuropathy
• Interventions: Drug: 0.075% Capsaicin Lotion; Drug: placebo

• Registration Number: NCT03113448
• Lead Sponsor: 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

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 Timeline

• Study Start: 2017-01-19
• Study First Submitted: 2017-04-09
• Study First Submitted QC: 2017-04-12
• Study First Posted: 2017-04-13
• Primary Completion: 2017-04-21
• Study Completion: 2018-01-31
• Status Verified: 2018-09
• Last Update Submitted: 2018-09-10
• Last Update Posted: 2018-09-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 42

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
0.075% Capsaicin Lotion	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	placebo	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
Placebo Lotion	0.075% Capsaicin 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
Placebo Lotion	placebo	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

Primary Outcome Measures

Name	Time	Method
Visual analog scale (0-100 mm.)	20 week	scale

Secondary Outcome Measures

Name	Time	Method
Neuropathic Pain Scale (NPS)	20 week	scale
Short-form McGill Pain Questionnaire(SF-MPQ)	20 week	scale

Trial Locations

Locations (1)

Thammasat University Hospital; 🇹🇭 Pathumthani, Thailand