0.075% Capsaicin Lotion for the Treatment of Painful Diabetic Neuropathy

Thammasat University

Status and phase: Completed; Phase 3

Conditions: Peripheral Diabetic Neuropathy

Treatments: Drug: 0.075% Capsaicin Lotion; Drug: placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT03113448

TCTR20170407001 (Other Identifier)

MTU-EC-IM-5-195/59

Details and patient eligibility

About

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

Full 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.

Enrollment: 42 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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42 participants in 2 patient groups, including a placebo group

0.075% Capsaicin Lotion

Active Comparator group

Description:

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

Treatment:

Drug: 0.075% Capsaicin Lotion

Drug: placebo

Placebo Lotion

Placebo Comparator group

Description:

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

Treatment:

Drug: 0.075% Capsaicin Lotion

Drug: placebo