0.075% Capsaicin Lotion for the Treatment of Painful Diab... | NCT03113448

Studies
0.075% Capsaicin Lotion for the Treatment of Painful Diabetic Neuropathy

NCT03113448

Sponsor

Thammasat University

Status

Completed

Last Update Posted

Sep 12, 2018Actual

Enrollment

42Actual

Phase

Phase 3

Conditions

Peripheral Diabetic Neuropathy

Interventions

0.075% Capsaicin Lotion
placebo

Countries

Thailand

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
TCTR20170407001	Other Identifier	Thai Clinical Trials Registry

Status Module

Record Verification Date

Sep 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 19, 2017Actual

Primary Completion Date

Apr 21, 2017Actual

Completion Date

Jan 31, 2018Actual

First Submitted Date

Apr 9, 2017

First Submission Date that Met QC Criteria

Apr 12, 2017

First Posted Date

Apr 13, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 10, 2018

Last Update Posted Date

Sep 12, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

42Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
0.075% Capsaicin Lotion	Active Comparator	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	Drug: 0.075% Capsaicin Lotion Drug: placebo
Placebo Lotion	Placebo Comparator	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	Drug: 0.075% Capsaicin Lotion Drug: placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
0.075% Capsaicin Lotion	Drug	To apply 3-4 times per day, every day until 8 weeks then stop	0.075% Capsaicin Lotion Placebo Lotion

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Visual analog scale (0-100 mm.)	scale	20 week

Secondary Outcomes

Measure	Description	Time Frame
Short-form McGill Pain Questionnaire(SF-MPQ)	scale	20 week
Neuropathic Pain Scale (NPS)	scale	20 week

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

DM type 2 over 1 year
Clinical presentation of peripheral sensory such as burning pain
DN4 score from 4 points
Good consciousness to tell their score with informed consent agreement
No adding dosage of previous pain control medications at least 4 weeks
HbA1C 6.5-9.0%

Exclusion Criteria:

Improper application site of skin for topical drugs such as abrasion wound.
Allergic history of Capsaicin
No intention to join the study with any reasons
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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Kongkiat Kulkantrakorn, Professor	Thammasat University Hospital	Study Chair
Pasiri Sithinamsuwan	Phramongkutklao College of Medicine	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Thammasat University Hospital		Pathum Thani		12120	Thailand

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
36729473	Derived	Mangwani-Mordani S, Goodman CF, Galor A. Novel Treatments for Chronic Ocular Surface Pain. Cornea. 2023 Mar 1;42(3):261-271. doi: 10.1097/ICO.0000000000003193. Epub 2022 Dec 19.

ID	Term
D009437	Neuralgia
D003929	Diabetic Neuropathies

ID	Term
D010523	Peripheral Nervous System Diseases
D009468	Neuromuscular Diseases
D009422	Nervous System Diseases
D010146	Pain