CompletedNCT02737618Updated Sep 1, 2017Results posted

14-Day Cumulative Irritation Patch Test in Subjects With Normal Skin - Chameleon

An interventional study of Trojan "Chameleon" Personal Lubricant in Dermal Irritation, sponsored by Church & Dwight Company, Inc.. Completed at 1 site in United States. Open to participants aged 18 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-09-01.

Sponsored by Church & Dwight Company, Inc. · Not applicable, Interventional, and Screening

Phase: Not applicable
Study type: Interventional
Enrollment: 35
Allocation: Not applicable
Ages: 18 Years to 70 Years
Sex: All

Study summary

to determine the ability of the test article to cause irritation to the skin of humans under controlled patch test conditions

Conditions studied

Dermal Irritation

In context

Lead sponsor

Church & Dwight Company, Inc. is the lead sponsor of 33 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 70 Years
Sexes eligible: All
Accepts healthy volunteers: Yes

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

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

Study design

Phase: Not applicable
Primary purpose: Screening
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrollment: 35 participants (actual)

Study arms

Experimental
Healthy subject
Healthy subjects exposed to Trojan "Chameleon" Personal Lubricant applied by occlusive patch
Device: Trojan "Chameleon" Personal Lubricant

Interventions

DeviceTrojan "Chameleon" Personal Lubricant
silicone base with sensate

What researchers measure

Primary outcomes

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

Posted Sep 1, 2017

Participant flow

Participant flow — Overall Study
Milestone	Healthy Subject
Started	43
Completed	34
Not completed	9
Withdrew: Withdrawal by subject	9

Outcome measures

PrimaryNumber of Subjects That Showed Erythema Based on 5 Point Scoring Scale

Time frame:: 14 days
Reported as:: Count of participants · Participants

Number of Subjects That Showed Erythema Based on 5 Point Scoring Scale
Participants	Healthy Subject
Number of Subjects That Showed Erythema Based on 5 Point Scoring Scale	0

PrimaryNumber of Subjects That Showed Edema Based on the 5 Point Scoring Scale

Time frame:: 14 days
Reported as:: Count of participants · Participants

Number of Subjects That Showed Edema Based on the 5 Point Scoring Scale
Participants	Healthy Subject
Number of Subjects That Showed Edema Based on the 5 Point Scoring Scale	0

Adverse events

Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Healthy Subject	—	0/34 (0%)	0/34 (0%)

Baseline characteristics

Age, Customized
Age, Customized(Participants)	Healthy Subject
18-69	34

Sex: Female, Male
Sex: Female, Male(Participants)	Healthy Subject
Female	28
Male	6

Race and Ethnicity Not Collected
Race and Ethnicity Not Collected(Participants)	Healthy Subject

Study locations

1 site

TKL Research Inc
Fair Lawn, New Jersey 07410, United States

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Sep 1, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT02737618
Lead sponsor: Church & Dwight Company, Inc.
Responsible party: Sponsor
First posted: Apr 14, 2016
Start date: Feb 2016
Primary completion: Mar 2016
Completion: Mar 2016
Results posted: Sep 1, 2017
Last update: Sep 1, 2017

Study contacts

John Dosik, MD

principal investigator · TKL Research, Inc.

Oversight

FDA-regulated device: Yes

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2017. You cannot join it, but the record below documents what was studied.

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Discussion

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Church & Dwight Company, Inc.

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