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

• 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.