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

Phase 4

Withdrawn

• Conditions: Skin Irritation
• Interventions: Other: Saline; Drug: Topical Spray; Drug: Topical Gel

• Registration Number: NCT02400320
• Lead Sponsor: GlaxoSmithKline

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-01-29
• Study First Submitted QC: 2015-03-23
• Study First Posted: 2015-03-27
• Study Start: 2016-03-01
• Primary Completion: 2016-06-01
• Study Completion: 2016-06-30
• Status Verified: 2017-09
• Last Update Submitted: 2017-09-11
• Last Update Posted: 2017-09-12

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Saline	Saline	Saline
Topical Spray	Topical Spray	Topical spray containing Diclofenac 1.16%, Linseed Oil 3%, Menthol 5%, Methyl salicylate 10%.
Topical Gel	Topical Gel	Topical gel containing Diclofenac 1.16%, Menthol 5%, Methyl salicylate 10%

Primary Outcome Measures

Name	Time	Method
Mean cumulative irritation score	7 days