A 24 Hour Occlusive Single Patch Test to Assess Acute Tolerance of Pre Lubricated Condom on a Panel of Healthy Adult Subjects

Study Overview
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Brief Summary
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This is a 24 hour patch test to determine the acute tolerance of 3 variants of condom on a panel of healthy adult subjects. The patches will be affixed to the back and remain under occlusion for 24 hours. They will then be assessed at 30 minutes and 24 hours post patch removal.

Detailed Description
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Three test products (plus positive and negative control) will be applied to the back using occlusive tape and will remain on the skin for 24 hours. The patches will be removed after 24 hours and assessed as 30 minutes post patch removal and again at 24 hours post patch removal. Each test site will be scored for erythema and oedema by a dermatologist. The primary endpoint for this Clinical Investigation is the irritation of the test products according to the Cutaneous Irritancy Index value. The test products success criteria is to be graded as 'non-irritant' and this should be confirmed by the study dermatologist.

Official Title
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A 24 Hour Occlusive Single Patch Test to Assess, Under Dermatological Control, the Acute Cutaneous Tolerance of Pre Lubricated Kiss Condom on a Panel of Healthy Adult Subjects

Conditions
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Healthy

Intervention / Treatment
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* Device: Condom


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects who are able to give written informed consent and from whom written informed consent has been obtained Generally healthy male or female subjects between the ages of 18 and 70 years inclusive. Subjects assessed by the dermatologist as having normal/healthy skin. Subjects with skin Phototype I to IV skin. Subjects who have been exposed to Natural Rubber Latex through condom use with no allergic reaction being raised Subjects, who are able to understand the study, co-operate with the study procedures (including no swimming during the study period) and are able to attend all study assessments. Exclusion Criteria: Female subjects who are pregnant, lactating or have given birth within the previous 3 months or are planning to be pregnant during the study. Female subjects of childbearing potential who, for the duration of the study, are either unwilling or unable to take adequate contraceptive precautions or are unwilling to be sexually abstinent. Subjects with previous experience of intolerance or allergic reactions to any components of the test products including latex and lubricants. Subjects with either form of diabetes. Subjects with an active skin disorder or a significant history of skin disorders (e.g. psoriasis, eczema, vitiligo, pityriasis versicolor, acne) which in the opinion of the Principle Investigator or dermatologist may affect the test results Subjects whose skin has been excessively exposed to the sun or to UV rays during the previous month in the opinion of the Investigator. Subjects who are suffering from chronic asthma, a malfunction of the lymphatic system or an autoimmune deficiency diseases (e.g. lupus, thyroiditis). Subjects with very easily irritated/sensitive skin in the opinion of the Investigator.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 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 |
| --- | --- |
| Other: Other<br>This is a safety study where a marketed product will be placed on healthy adult skin. | Device: Condom<br>* This study involves testing a condom, however the device will not be used as intended. The device will be destroyed to make the test patches required for this safety study.<br>* Other names: Durex;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary endpoint is the irritation of the test products according to the Cutaneous Irritancy Index value. The test products are expected to be graded as 'non-irritant' as confirmed by a dermatologist. | Acute tolerance study to test the safety of a new condom on healthy adult skin. | 24 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Safety study, new product, normal healthy skin.