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

September 8, 2016 updated by: Reckitt Benckiser Healthcare (UK) Limited

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

33

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
OTHER: Other
This is a safety study where a marketed product will be placed on healthy adult skin.
Device: Condom
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.
Other Names:
  • Durex

What is the study measuring?

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.
Time Frame: 24 hours
Acute tolerance study to test the safety of a new condom on healthy adult skin.
24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Reckitt Benckiser Healthcare (UK) Limited

Collaborators

Alba Science Ltd

Investigators

  • Principal Investigator: Marie Reynolds, Alba Science Ltd

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2016

Primary Completion (ACTUAL)

May 1, 2016

Study Completion (ACTUAL)

May 1, 2016

Study Registration Dates

First Submitted

July 28, 2016

First Submitted That Met QC Criteria

August 9, 2016

First Posted (ESTIMATE)

August 12, 2016

Study Record Updates

Last Update Posted (ESTIMATE)

September 9, 2016

Last Update Submitted That Met QC Criteria

September 8, 2016

Last Verified

December 1, 2015

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • NPD81401

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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