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

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ClinicalTrials.gov Identifier: NCT02737618
Recruitment Status : Completed
First Posted : April 14, 2016
Results First Posted : September 1, 2017
Last Update Posted : September 1, 2017
Sponsor:
Information provided by (Responsible Party):
Church & Dwight Company, Inc.

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Screening
Condition Dermal Irritation
Intervention Device: Trojan "Chameleon" Personal Lubricant
Enrollment 35
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Healthy Subject
Hide Arm/Group Description

Healthy subjects exposed to Trojan "Chameleon" Personal Lubricant applied by occlusive patch

Trojan "Chameleon" Personal Lubricant: silicone base with sensate

Period Title: Overall Study
Started 43
Completed 34
Not Completed 9
Reason Not Completed
Withdrawal by Subject             9
Arm/Group Title Healthy Subject
Hide Arm/Group Description

Healthy subjects exposed to Trojan "Chameleon" Personal Lubricant applied by occlusive patch

Trojan "Chameleon" Personal Lubricant: silicone base with sensate

Overall Number of Baseline Participants 34
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
18-69 Number Analyzed 34 participants
34
 100.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 34 participants
Female
28
  82.4%
Male
6
  17.6%
Race and Ethnicity Not Collected   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 0 participants
[1]
Measure Analysis Population Description: Race and Ethnicity were not collected from any participant.
1.Primary Outcome
Title Number of Subjects That Showed Erythema Based on 5 Point Scoring Scale
Hide Description [Not Specified]
Time Frame 14 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Healthy Subject
Hide Arm/Group Description:

Healthy subjects exposed to Trojan "Chameleon" Personal Lubricant applied by occlusive patch

Trojan "Chameleon" Personal Lubricant: silicone base with sensate

Overall Number of Participants Analyzed 34
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
2.Primary Outcome
Title Number of Subjects That Showed Edema Based on the 5 Point Scoring Scale
Hide Description [Not Specified]
Time Frame 14 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Healthy Subject
Hide Arm/Group Description:

Healthy subjects exposed to Trojan "Chameleon" Personal Lubricant applied by occlusive patch

Trojan "Chameleon" Personal Lubricant: silicone base with sensate

Overall Number of Participants Analyzed 34
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Healthy Subject
Hide Arm/Group Description

Healthy subjects exposed to Trojan "Chameleon" Personal Lubricant applied by occlusive patch

Trojan "Chameleon" Personal Lubricant: silicone base with sensate

All-Cause Mortality
Healthy Subject
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Healthy Subject
Affected / at Risk (%)
Total   0/34 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Healthy Subject
Affected / at Risk (%)
Total   0/34 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Confidentiality agreement in place with PI
Results Point of Contact
Name/Title: Annahita Ghassemi
Organization: Church & Dwight Co., Inc
Phone: 6098061200
Responsible Party: Church & Dwight Company, Inc.
ClinicalTrials.gov Identifier: NCT02737618     History of Changes
Other Study ID Numbers: ST-7611
First Submitted: March 22, 2016
First Posted: April 14, 2016
Results First Submitted: August 2, 2017
Results First Posted: September 1, 2017
Last Update Posted: September 1, 2017