Dermal IrritationNCT02737618
14-Day Cumulative Irritation Patch Test in Subjects With Normal Skin - Chameleon
A study testing Trojan "Chameleon" Personal Lubricant in people with Dermal Irritation, run by Church & Dwight Company, Inc. at 1 site in United States.
Trial summary
to determine the ability of the test article to cause irritation 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
- Conditions the study is for
- Dermal Irritation
- What is being tested?
- Trojan "Chameleon" Personal Lubricant
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- male or female, 18-70 years of age, in general good health
- normal skin
- 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
- of any skin type or race providing the skin pigmentation will allow discernment of erythema
- agree to complete a medical history and concomitant medication form
- read, understand and sign 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 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
- have a known sensitivity to cosmetics, skin care test articles, or topical drugs as related to the test article being evaluated
- are females who are pregnant or breastfeeding or become pregnant
Trial locations and contacts
1 site in 1 country.
About this study
to determine the ability of the test article to cause irritation to the skin of humans under controlled patch test conditions
- Conditions
- Dermal Irritation
- Being tested
- Trojan "Chameleon" Personal Lubricant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trojan "Chameleon" Personal LubricantDevice
silicone base with sensate
| Study group | Role | What they receive |
|---|---|---|
| Healthy subject | Experimental | Healthy subjects exposed to Trojan "Chameleon" Personal Lubricant applied by occlusive patch Receives: Device: Trojan "Chameleon" Personal Lubricant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Subjects That Showed Erythema Based on 5 Point Scoring Scale
Measured: 14 days
Number of Subjects That Showed Edema Based on the 5 Point Scoring Scale
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 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 Dermal 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
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Church & Dwight Company, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- John Dosik, MD, Principal investigator, TKL Research, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02737618
- Sponsor's protocol ID
- ST-7611
- Status last verified
- Aug 2017
- First submitted
- 22 Mar 2016
- Last updated
- 1 Sep 2017
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2017. 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 - Chameleon
- ClinicalTrials.gov ID
- NCT02737618
- Acronym / sponsor ID
- ST-7611
- Conditions
- Dermal Irritation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 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.
to determine the ability of the test article to cause irritation 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 |
|---|---|---|
| Healthy subject | Experimental | Device: Trojan "Chameleon" Personal LubricantHealthy subjects exposed to Trojan "Chameleon" Personal Lubricant applied by occlusive patch |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- male or female, 18-70 years of age, in general good health
- normal skin
- 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
- of any skin type or race providing the skin pigmentation will allow discernment of erythema
- agree to complete a medical history and concomitant medication form
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
- have a known sensitivity to cosmetics, skin care test articles, or topical drugs as related to the test article being evaluated
- are females who are pregnant or breastfeeding or become pregnant
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 |
|---|---|---|
| Trojan "Chameleon" Personal Lubricantsilicone base with sensate | Device | Healthy subject |
Primary outcome
Number of Subjects That Showed Erythema Based on 5 Point Scoring Scale
Time frame: 14 days
Number of Subjects That Showed Edema Based on the 5 Point Scoring Scale
Time frame: 14 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Dermal Irritation
Active, not recruitingPhase 1
Safety of Topical Exosome-Containing Liquid in Healthy Volunteers
Skin Irritation, Healthy Volunteers
Recruiting
Dermal Acceptability Evaluation in Sensitive Skin
Sensitive Skin
Not yet recruitingPhase 1
Safety of Topical Exosome-Containing Liquid in Healthy Volunteers for Future Surgical Wound Use
Healthy Volunteers (HV), Skin Irritation
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.
John Dosik, MD principal investigator
TKL Research, 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 Trojan "Chameleon" Personal Lubricant in people with Dermal 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 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 1 Sep 2017. 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 Subjects That Showed Erythema Based on 5 Point Scoring Scale (time frame: 14 days). The study lists 2 primary outcomes in all. 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 1 Sep 2017.