HealthyNCT02864966
A 24 Hour Occlusive Single Patch Test to Assess Acute Tolerance of Pre Lubricated Condom on a Panel of Healthy Adult Subjects
A study testing Condom in people with Healthy, run by Reckitt Benckiser Healthcare (UK) Limited at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Condom
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- May 2016to May 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Healthy
- Being tested
- Condom
- Keywords
- Safety study, new product, normal healthy skin.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CondomDevice
Also called Durex
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.
| Study group | Role | What they receive |
|---|---|---|
| Other | Other | This is a safety study where a marketed product will be placed on healthy adult skin. Receives: Device: Condom |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2016 (estimated)
- Study startMay 2016
- Primary completionMay 2016
- Study completionMay 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Reckitt Benckiser Healthcare (UK) Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Alba Science Ltd
- Responsible party
- Sponsor
- Investigators
- Marie Reynolds, Principal investigator, Alba Science Ltd
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02864966
- Sponsor's protocol ID
- NPD81401
- Status last verified
- Dec 2015
- First submitted
- 28 Jul 2016
- Last updated
- 9 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT02864966
- Acronym / sponsor ID
- NPD81401
- Conditions
- Healthy
- Keywords
- Safety study, new product, normal healthy skin.
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Reckitt Benckiser Healthcare (UK) LimitedIndustry (pharma, biotech, devices)
- Collaborators
- Alba Science Ltd
- Study start
- May 2016
- Primary completion
- May 2016 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 12 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Other | Other | Device: CondomThis is a safety study where a marketed product will be placed on healthy adult skin. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CondomAlso: DurexThis 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. | Device | Other |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marie Reynolds principal investigator
Alba Science Ltd
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Condom in people with Healthy, run by Reckitt Benckiser Healthcare (UK) Limited at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2016.