14-Day Cumulative Irritation Patch Test in Subjects With Normal Skin

Study Overview
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Brief Summary
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The objective of this study is to determine the ability of the study material to cause irritation to the skin of humans under controlled patch test conditions. Substances that come into contact with human skin need to be evaluated for their propensity to irritate and/or sensitize. This testing is a modified primary irritancy patch test that can detect weak irritants that require multiple applications to cause a skin reaction.

Conditions
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Cumulative Irritation

Intervention / Treatment
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* Device: Novel lubricant Miami w/ fragrance
* Device: Novel lubricant Miami no fragrance
* Device: KY Liquid lubricant
* Device: Astroglide Gel lubricant
* Device: Wet Platinum lubricant


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Are a male or female, 18 years of age or older, in general good health; Have normal skin; Are free of any systemic or dermatologic disorder which, in the opinion of the investigative personnel, will interfere with the study results or increase the risk of adverse events; Are of any skin type or race providing the skin pigmentation will allow discernment of erythema; Complete a medical screening procedure; and Read, understand, and sign an informed consent. Exclusion Criteria: Have any visible skin disease at the study site which, in the opinion of the investigative personnel, will interfere with the evaluation; Are receiving systematic or topical drugs or medication which, in the opinion of the investigative personnel, will interfere with the study results; Have psoriasis and/or active atopic dermatitis/eczema; and/or Have a known sensitivity to cosmetics, skin care products, or topical drugs as related to the material being evaluated.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Healthy Subject<br>Occlusive patches applied each day for 14 days for each intervention (Experimental: Novel lubricant Miami w/ fragrance, Experimental: Novel lubricant Miami no fragrance, KY Liquid lubricant, Astroglide Gel lubricant, Wet Platinum lubricant). | Device: Novel lubricant Miami w/ fragrance<br>* 0.2 ml aliquot on occlusive patch<br>Device: Novel lubricant Miami no fragrance<br>* 0.2 ml aliquot on occlusive patch<br>Device: KY Liquid lubricant<br>* 0.2 ml aliquot on occlusive patch<br>Device: Astroglide Gel lubricant<br>* 0.2 ml aliquot on occlusive patch<br>Device: Wet Platinum lubricant<br>* 0.2 ml aliquot on occlusive patch<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Subjects That Showed no Significant Irritation | Score of less than or equal to 1.2 on the Cumulative Irritation Test scale (0-5). | 14 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Patch Test