A 24 Hour Occlusive Single Patch Test to Assess Acute Tol... | NCT02864966

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

NCT02864966

Sponsor

Reckitt Benckiser Healthcare (UK) Limited

Status

Completed

Last Update Posted

Sep 9, 2016Estimated

Enrollment

33Actual

Phase

Not Applicable

Conditions

Healthy

Interventions

Condom

Countries

United Kingdom

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2016

Primary Completion Date

May 2016Actual

Completion Date

May 2016Actual

First Submitted Date

Jul 28, 2016

First Submission Date that Met QC Criteria

Aug 9, 2016

First Posted Date

Aug 12, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 8, 2016

Last Update Posted Date

Sep 9, 2016Estimated

Name	Class
Alba Science Ltd	UNKNOWN

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

33Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Other	Other	This is a safety study where a marketed product will be placed on healthy adult skin.	Device: Condom

Interventions

Name	Type	Description	Arm Group Labels	Other Names
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.

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D003275	Contraceptive Devices, Male
D003273	Contraceptive Devices
D004864	Equipment and Supplies