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Local Skin Safety Study of a Topical Pain Relief Spray Containing a Combination of Diclofenac, Methyl Salicylate, and Menthol

NCT02400320 · Status: WITHDRAWN · Phase: PHASE4 · Type: INTERVENTIONAL

Last updated 2017-09-12

No results posted yet for this study

Summary

The purpose of this study is to determine local skin safety of a topical analgesic spray containing a combination of diclofenac, methyl salicylate, menthol and compare it with a topical analgesic gel containing a combination of diclofenac, methyl salicylate, and menthol.

Conditions

  • Skin Irritation

Interventions

DRUG

Topical Spray

Topical spray containing Diclofenac 1.16%, Linseed Oil 3%, Menthol 5%, Methyl salicylate 10%.

DRUG

Topical Gel

Topical gel containing Diclofenac 1.16%, Menthol 5%, Methyl salicylate 10%

OTHER

Saline

Saline

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-03-01
Primary Completion
2016-06-01
Completion
2016-06-30

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Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02400320 on ClinicalTrials.gov