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

NCT02864966 | Completed

• 1 other identifier: NPD81401
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy

Keywords

Safety study; new product; normal healthy skin.

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Other

OTHER

This is a safety study where a marketed product will be placed on healthy adult skin.

Device: Condom

Interventions

Condom DEVICE

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.

Also known as: Durex

Other

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Reckitt Benckiser Healthcare (UK) Limited: lead
• Alba Science Ltd: collaborator

Study Sites (1)

Alba Science Ltd

Edinburgh, EH1 3RH, United Kingdom

Location

MeSH Terms

Interventions

Condoms

Intervention Hierarchy (Ancestors)

Contraceptive Devices, Male; Contraceptive Devices; Equipment and Supplies

Study Officials

• Marie Reynolds

  Alba Science Ltd

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 28, 2016
• First Posted: August 12, 2016
• Study Start: May 1, 2016
• Primary Completion: May 1, 2016
• Study Completion: May 1, 2016
• Last Updated: September 9, 2016

Record last verified: 2015-12

Locations

GB (1)