ErythemaNCT02297841
Repeated Insult Patch Test of Personal Lubricants
A study testing Experimental: Novel lubricant Miami Fragrance, Experimental: Novel lubricant Miami no Fragrance and KY Liquid lubricant in people with Erythema and Edema, run by Church & Dwight Company, Inc..
Trial summary
Determine the ability of the study material (personal lubricant) to cause sensitization by repeated topical application to the skin of humans under controlled patch test conditions. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- What is being tested?
- Experimental: Novel lubricant Miami Fragrance, Experimental: 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
- 209 participants
- Where
- No sites listed yet
- Study dates
- Nov 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 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- In general good health
- 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
- Read, understand, and sign an informed consent agreement
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 systemic 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.
- Are females who are pregnant, planning on getting pregnant during the study, or breast-feeding
- Have a known sensitivity for cosmetics, skin care products, topical drugs, or any other type of the products, as related to the material being evaluated
About this study
Determine the ability of the study material (personal lubricant) to cause sensitization by repeated topical application to the skin of humans under controlled patch test conditions.
- Being tested
- Experimental: Novel lubricant Miami Fragrance, Experimental: Novel lubricant Miami no Fragrance, KY Liquid lubricant, Astroglide Gel lubricant
- Medical subject headings
- Erythema, Edema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental: Novel lubricant Miami FragranceDevice
Experimental: Novel lubricant Miami no FragranceDevice
KY Liquid lubricantDevice
Astroglide Gel lubricantDevice
| Study group | Role | What they receive |
|---|---|---|
| Human Repeat Insult Patch Test | Experimental | Approximately 0.2ml of each intervention (Experimental: Novel lubricant Miami Fragrance, Experimental: Novel lubricant Miami no Fragrance, KY Liquid lubricant, Astroglide Gel lubricant) was applied to an occlusive patch and applied to participant's back. Receives: Device: Experimental: Novel lubricant Miami Fragrance; Device: Experimental: Novel lubricant Miami no Fragrance; Device: KY Liquid lubricant; Device: Astroglide Gel lubricant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Adverse Events as a Measure of Safety and Tolerability
Measured: 24, 48, and 72 hours after patch application
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2014 (estimated)
- Study startNov 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 ErythemaStudies 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
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 209 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
- NCT02297841
- Sponsor's protocol ID
- ST-7554
- Status last verified
- Sep 2016
- First submitted
- 17 Nov 2014
- Last updated
- 5 Oct 2016
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Repeated Insult Patch Test of Personal Lubricants
- ClinicalTrials.gov ID
- NCT02297841
- Acronym / sponsor ID
- ST-7554
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 209 participants (actual)
- Lead sponsor
- Church & Dwight Company, Inc.Industry (pharma, biotech, devices)
- Study start
- Nov 2014
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 21 Nov 2014 (estimated)
- Results
- Posted 5 Oct 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Determine the ability of the study material (personal lubricant) to cause sensitization by repeated topical application to the skin of humans under controlled patch test conditions.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Human Repeat Insult Patch Test | Experimental | Device: Experimental: Novel lubricant Miami Fragrance, Device: Experimental: Novel lubricant Miami no Fragrance, Device: KY Liquid lubricant, Device: Astroglide Gel lubricantApproximately 0.2ml of each intervention (Experimental: Novel lubricant Miami Fragrance, Experimental: Novel lubricant Miami no Fragrance, KY Liquid lubricant, Astroglide Gel lubricant) was applied to an occlusive patch and applied to participant's back. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- In general good health
- 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
- Read, understand, and sign an informed consent agreement
Key exclusion criteria (5 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 systemic 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.
- Are females who are pregnant, planning on getting pregnant during the study, or breast-feeding
- Have a known sensitivity for cosmetics, skin care products, topical drugs, or any other type of the products, 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 |
|---|---|---|
| Experimental: Novel lubricant Miami Fragrance | Device | Human Repeat Insult Patch Test |
| Experimental: Novel lubricant Miami no Fragrance | Device | Human Repeat Insult Patch Test |
| KY Liquid lubricant | Device | Human Repeat Insult Patch Test |
| Astroglide Gel lubricant | Device | Human Repeat Insult Patch Test |
Primary outcome
Number of Participants With Adverse Events as a Measure of Safety and Tolerability
Time frame: 24, 48, and 72 hours after patch application
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Experimental: Novel lubricant Miami Fragrance, Experimental: Novel lubricant Miami no Fragrance and KY Liquid lubricant in people with Erythema and Edema, run by Church & Dwight Company, Inc..
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 5 inclusion and 5 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 5 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
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 5 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 Participants With Adverse Events as a Measure of Safety and Tolerability (time frame: 24, 48, and 72 hours after patch application). 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 5 Oct 2016.