ErythemaHRIPTNCT02737631
Human Repeat Insult Patch Test to Evaluate Personal Lubricants
A study testing "Chameleon" Personal Lubricant in people with Erythema and Edema, run by Church & Dwight Company, Inc. at 1 site in United States.
Trial summary
The purpose of this test is to evaluate the sensitizing potential of a personal lubricant, as a result of repeated occlusive patch. The intervention will be applied for a total of 9 induction applications, followed by an approximately 2 week rest period, then followed by a 24-72 hour Challenge applications. Read more about this study
- Who is it for?
- Ages 18 to 69 yearsHealthy volunteers can take part
- What is being tested?
- "Chameleon" Personal Lubricant
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 222 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2016to Mar 2016
- 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 69 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- good health as determined from screener
- signed and dated informed consent
- signed and dated HIPAA Form
Who cannot join
- subjects on test at any other research laboratory or clinic
- known allergy or sensitivity to cosmetics and toiletries, including sunscreens, adhesives and/or topical drugs
- pre-existing dermatologic conditions which have been diagnosed by a medical professional (e.g. psoriasis, eczema, etc.) which would interfere with this study
- pre-existing other medical conditions (e.g. adult asthma, diabetes).
- treatment with antibiotics, antihistamines or corticosteroids within two weeks prior to initiation of the test
- chronic medication which could affect the results of the study (e.g., insulin, corticosteroids, antihistimines, steroidal or non-steroidal anti-inflammatory drugs [except for therapeutic maintenance dosage of aspirin], antibiotics, steroid inhalers, etc.)
- known pregnant or nursing women
Trial locations and contacts
1 site in 1 country.
United States1 site
Harrison Research Laboratories, Inc.
Union, New Jersey, 07083
About this study
The purpose of this test is to evaluate the sensitizing potential of a personal lubricant, as a result of repeated occlusive patch. The intervention will be applied for a total of 9 induction applications, followed by an approximately 2 week rest period, then followed by a 24-72 hour Challenge applications.
- Being tested
- "Chameleon" Personal 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.
"Chameleon" Personal LubricantDevice
| Study group | Role | What they receive |
|---|---|---|
| Healthy subject | Experimental | Healthy subjects exposed to "Chameleon" personal lubricant via occlusive patch Receives: Device: "Chameleon" Personal Lubricant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Patients That Showed Sensitization Reaction to the Test Material at Challenge
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 posted14 Apr 2016 (estimated)
- Study startFeb 2016
- Primary completionMar 2016
- Study completionMar 2016
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
- 222 participants (actual)
Sponsor and investigators
- Lead sponsor
- Church & Dwight Company, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Lynne B Harrison, PhD, Principal investigator, Harrison Research Laboratories, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02737631
- Sponsor's protocol ID
- ST-7619
- Acronym
- HRIPT
- Status last verified
- Mar 2021
- First submitted
- 29 Feb 2016
- Last updated
- 15 Apr 2021
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Human Repeat Insult Patch Test to Evaluate Personal Lubricants
- ClinicalTrials.gov ID
- NCT02737631
- Acronym / sponsor ID
- HRIPT / ST-7619
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 222 participants (actual)
- Lead sponsor
- Church & Dwight Company, Inc.Industry (pharma, biotech, devices)
- Study start
- Feb 2016
- Primary completion
- Mar 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 14 Apr 2016 (estimated)
- Results
- Posted 1 Sep 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this test is to evaluate the sensitizing potential of a personal lubricant, as a result of repeated occlusive patch. The intervention will be applied for a total of 9 induction applications, followed by an approximately 2 week rest period, then followed by a 24-72 hour Challenge applications.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthy subject | Experimental | Device: "Chameleon" Personal LubricantHealthy subjects exposed to "Chameleon" personal lubricant via occlusive patch |
Who may qualify
- Ages
- 18 to 69 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- good health as determined from screener
- signed and dated informed consent
- signed and dated HIPAA Form
Key exclusion criteria (7 listed)
- subjects on test at any other research laboratory or clinic
- known allergy or sensitivity to cosmetics and toiletries, including sunscreens, adhesives and/or topical drugs
- pre-existing dermatologic conditions which have been diagnosed by a medical professional (e.g. psoriasis, eczema, etc.) which would interfere with this study
- pre-existing other medical conditions (e.g. adult asthma, diabetes).
- treatment with antibiotics, antihistamines or corticosteroids within two weeks prior to initiation of the test
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 |
|---|---|---|
| "Chameleon" Personal Lubricant | Device | Healthy subject |
Primary outcome
Number of Patients That Showed Sensitization Reaction to the Test Material at Challenge
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 15 Apr 2021.
- 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.
Lynne B Harrison, PhD principal investigator
Harrison Research Laboratories, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing "Chameleon" Personal Lubricant in people with Erythema and Edema, 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 3 inclusion and 7 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 15 Apr 2021. 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 1 Sep 2017). 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 Patients That Showed Sensitization Reaction to the Test Material at Challenge (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 15 Apr 2021; AzTrials last refreshed its copy on 28 Oct 2026.