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

Topical therapy may provide additional benefit in patients with painful diabetic neuropathy (PDN).This study was conducted to study the safety and efficacy of0.075% capsaicin lotion in this condition

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
TCTR
Registry ID
TCTR20170407001
Enrollment
42
Registered
2017-04-07
Start date
2017-01-19
Completion date
Unknown
Last updated
2026-03-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gastrointestinal disorders&#44

Interventions

0.075% Capsaicin Lotion is used for application at skin area involved with symptomatic neuropathic pain (both feet or/and hands)&#44
everyday for 8 weeks then stop,Placebo Lotion is used for application at skin area involved with symptomatic neuropathic pain (both feet or/and hands)&#44
everyday for 8 weeks then stop
Active Comparator Drug,Placebo Comparator Drug
0.075% Capsaicin Lotion,Placebo

Sponsors

BANGKOK DRUG CO.,LTD
Lead Sponsor
Thammasat University
Collaborator

Eligibility

Sex/Gender
All
Age
20 Years to No maximum

Inclusion 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

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 nutritiion, kidney failure, chronic alcholism, vitamin deficiency, Hypothyroidism

Design outcomes

Primary

MeasureTime frame
Visual analog scale (0-100 mm.) at 20 weeks after end of the intervention scale

Secondary

MeasureTime frame
Short-form McGill Pain Questionnaire(SF-MPQ) at 20 weeks after end of the intervention scale,Neuropathic Pain Scale (NPS) at 20 weeks after end of the intervention scale

Countries

Thailand

Contacts

Public ContactAssawin Chomjit

Unaffiliated

cescassawin@gmail.com+66-874949239

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Apr 4, 2026