Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 4:32 PM
Ignite Modification Date:
2025-12-24 @ 4:32 PM
NCT ID:
NCT02864966
Eligibility Criteria:
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.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT02864966
Study Brief:
Protocol Section:
NCT02864966