Cumulative IrritationNCT02309294
14-Day Cumulative Irritation Patch Test in Subjects With Normal Skin
A study testing Novel lubricant Miami w/ fragrance, Novel lubricant Miami no fragrance and KY Liquid lubricant in people with Cumulative Irritation, run by Church & Dwight Company, Inc. at 1 site in United States.
Trial summary
The objective of this study is to determine the ability of the study material to cause irritation to the skin of humans under controlled patch test conditions. Substances that come into contact with human skin need to be evaluated for their propensity to irritate and/or sensitize. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cumulative Irritation
- What is being tested?
- Novel lubricant Miami w/ fragrance, Novel lubricant Miami no fragrance and KY Liquid lubricant
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2014to Dec 2014
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Are a male or female, 18 years of age or older, in general good health;
- Have normal skin;
- Are free of any systemic or dermatologic disorder which, in the opinion of the investigative personnel, will interfere with the study results or increase the risk of adverse events;
- Are of any skin type or race providing the skin pigmentation will allow discernment of erythema;
- Complete a medical screening procedure; and
- Read, understand, and sign an informed consent.
Who cannot join
- Have any visible skin disease at the study site which, in the opinion of the investigative personnel, will interfere with the evaluation;
- Are receiving systematic or topical drugs or medication which, in the opinion of the investigative personnel, will interfere with the study results;
- Have psoriasis and/or active atopic dermatitis/eczema; and/or
- Have a known sensitivity to cosmetics, skin care products, or topical drugs as related to the material being evaluated.
Trial locations and contacts
1 site in 1 country.
About this study
The objective of this study is to determine the ability of the study material to cause irritation to the skin of humans under controlled patch test conditions. Substances that come into contact with human skin need to be evaluated for their propensity to irritate and/or sensitize. This testing is a modified primary irritancy patch test that can detect weak irritants that require multiple applications to cause a skin reaction.
- Conditions
- Cumulative Irritation
- Being tested
- Novel lubricant Miami w/ fragrance, Novel lubricant Miami no fragrance, KY Liquid lubricant, Astroglide Gel lubricant, Wet Platinum lubricant
- Keywords
- Patch Test
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Novel lubricant Miami w/ fragranceDevice
0.2 ml aliquot on occlusive patch
Novel lubricant Miami no fragranceDevice
0.2 ml aliquot on occlusive patch
KY Liquid lubricantDevice
0.2 ml aliquot on occlusive patch
Astroglide Gel lubricantDevice
0.2 ml aliquot on occlusive patch
Wet Platinum lubricantDevice
0.2 ml aliquot on occlusive patch
| Study group | Role | What they receive |
|---|---|---|
| Healthy Subject | Experimental | Occlusive patches applied each day for 14 days for each intervention (Experimental: Novel lubricant Miami w/ fragrance, Experimental: Novel lubricant Miami no fragrance, KY Liquid lubricant, Astroglide Gel lubricant, Wet Platinum lubricant). Receives: Device: Novel lubricant Miami w/ fragrance; Device: Novel lubricant Miami no fragrance; Device: KY Liquid lubricant; Device: Astroglide Gel lubricant; Device: Wet Platinum lubricant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Subjects That Showed no Significant Irritation
Score of less than or equal to 1.2 on the Cumulative Irritation Test scale (0-5).
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2014 (estimated)
- Study startDec 2014
- Primary completionDec 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Cumulative IrritationStudies 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
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Church & Dwight Company, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02309294
- Sponsor's protocol ID
- ST-7553
- Status last verified
- Oct 2016
- First submitted
- 3 Dec 2014
- Last updated
- 12 Oct 2016
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 14-Day Cumulative Irritation Patch Test in Subjects With Normal Skin
- ClinicalTrials.gov ID
- NCT02309294
- Acronym / sponsor ID
- ST-7553
- Conditions
- Cumulative Irritation
- Keywords
- Patch Test
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Church & Dwight Company, Inc.Industry (pharma, biotech, devices)
- Study start
- Dec 2014
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 5 Dec 2014 (estimated)
- Results
- Posted 12 Oct 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this study is to determine the ability of the study material to cause irritation to the skin of humans under controlled patch test conditions. Substances that come into contact with human skin need to be evaluated for their propensity to irritate and/or sensitize. This testing is a modified primary irritancy patch test that can detect weak irritants that require multiple applications to cause a skin reaction.
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthy Subject | Experimental | Device: Novel lubricant Miami w/ fragrance, Device: Novel lubricant Miami no fragrance, Device: KY Liquid lubricant, Device: Astroglide Gel lubricant, Device: Wet Platinum lubricantOcclusive patches applied each day for 14 days for each intervention (Experimental: Novel lubricant Miami w/ fragrance, Experimental: Novel lubricant Miami no fragrance, KY Liquid lubricant, Astroglide Gel lubricant, Wet Platinum lubricant). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Are a male or female, 18 years of age or older, in general good health;
- Have normal skin;
- Are free of any systemic or dermatologic disorder which, in the opinion of the investigative personnel, will interfere with the study results or increase the risk of adverse events;
- Are of any skin type or race providing the skin pigmentation will allow discernment of erythema;
- Complete a medical screening procedure; and
Key exclusion criteria (4 listed)
- Have any visible skin disease at the study site which, in the opinion of the investigative personnel, will interfere with the evaluation;
- Are receiving systematic or topical drugs or medication which, in the opinion of the investigative personnel, will interfere with the study results;
- Have psoriasis and/or active atopic dermatitis/eczema; and/or
- Have a known sensitivity to cosmetics, skin care products, or topical drugs as related to the material being evaluated.
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 |
|---|---|---|
| Novel lubricant Miami w/ fragrance0.2 ml aliquot on occlusive patch | Device | Healthy Subject |
| Novel lubricant Miami no fragrance0.2 ml aliquot on occlusive patch | Device | Healthy Subject |
| KY Liquid lubricant0.2 ml aliquot on occlusive patch | Device | Healthy Subject |
| Astroglide Gel lubricant0.2 ml aliquot on occlusive patch | Device | Healthy Subject |
| Wet Platinum lubricant0.2 ml aliquot on occlusive patch | Device | Healthy Subject |
Primary outcome
Number of Subjects That Showed no Significant Irritation
Time frame: 14 days
Score of less than or equal to 1.2 on the Cumulative Irritation Test scale (0-5).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Novel lubricant Miami w/ fragrance, Novel lubricant Miami no fragrance and KY Liquid lubricant in people with Cumulative Irritation, run by Church & Dwight Company, Inc. at 1 site in United States.
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 4 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 12 Oct 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 States. 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?
Yes. Results are posted in the registry (first posted 12 Oct 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Subjects That Showed no Significant Irritation (time frame: 14 days). 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 12 Oct 2016.