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A Safety Study to Investigate the Skin Irritancy Potential of Diclofenac-Menthol Gel

NCT02169154 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2017-06-29

No results posted yet for this study

Summary

This research study is being conducted to investigate the skin irritancy potential of a new medication which contains two active ingredients (diclofenac and menthol) together in a gel formulation and is being developed to treat mild to moderate pain and inflammation, such as acute sport injuries, sprains and strains.

Conditions

Interventions

DRUG

1% Diclofenac Sodium

1% diclofenac sodium

DRUG

3% Menthol

3% Menthol

DRUG

0.09% Menthol

0.09% Menthol

DRUG

0.2% Sodium Lauryl Sulfate

0.2% Sodium Lauryl Sulfate

DRUG

0.9% Saline

0.9% Saline

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-06-01
Primary Completion
2014-07-01
Completion
2014-07-01

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases
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 NCT02169154 on ClinicalTrials.gov