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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Topical Spray | Active Comparator | Topical spray containing Diclofenac 1.16%, Linseed Oil 3%, Menthol 5%, Methyl salicylate 10%. |
|
| Topical Gel | Experimental | Topical gel containing Diclofenac 1.16%, Menthol 5%, Methyl salicylate 10% |
|
| Saline | Other | Saline |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Topical Spray | Drug | Topical spray containing Diclofenac 1.16%, Linseed Oil 3%, Menthol 5%, Methyl salicylate 10%. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean cumulative irritation score | 7 days |
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Inclusion Criteria
Healthy male or female volunteers aged at least 18 years.
Good general, physical and mental health in the opinion of the investigator or medically qualified designee:
Healthy volunteers who do not have excessive hair on the volar aspect of the forearm(s).
Healthy volunteers should understand and be willing to fully comply with all study procedures and restrictions.
Demonstrates understanding of the study and willingness to participate as evidenced by voluntary written informed consent and has received a signed and dated copy of the informed consent form.
Females of childbearing potential, using an effective contraceptive method for at least one month before the beginning of the study, and willing to use throughout the study
Exclusion Criteria
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
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| ID | Term |
|---|---|
| D005782 | Gels |
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D003102 | Colloids |
| D045424 | Complex Mixtures |
| D004304 | Dosage Forms |
| D004364 | Pharmaceutical Preparations |
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| Topical Gel | Drug | Topical gel containing Diclofenac 1.16%, Menthol 5%, Methyl salicylate 10% |
|
| Saline | Other | Saline |
|
| D002712 |
| Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |