14-Day Cumulative Irritation Patch Test in Subjects With Normal Skin - Chameleon
1 other identifier
interventional
35
1 country
1
Brief Summary
to determine the ability of the test article to cause irritation to the skin of humans under controlled patch test conditions
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Feb 2016
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2016
CompletedFirst Submitted
Initial submission to the registry
March 22, 2016
CompletedFirst Posted
Study publicly available on registry
April 14, 2016
CompletedResults Posted
Study results publicly available
September 1, 2017
CompletedSeptember 1, 2017
August 1, 2017
29 days
March 22, 2016
August 2, 2017
August 2, 2017
Conditions
Outcome Measures
Primary Outcomes (2)
Number of Subjects That Showed Erythema Based on 5 Point Scoring Scale
14 days
Number of Subjects That Showed Edema Based on the 5 Point Scoring Scale
14 days
Study Arms (1)
Healthy subject
EXPERIMENTALHealthy subjects exposed to Trojan "Chameleon" Personal Lubricant applied by occlusive patch
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
TKL Research Inc
Fair Lawn, New Jersey, 07410, United States
Results Point of Contact
- Title
- Annahita Ghassemi
- Organization
- Church & Dwight Co., Inc
Study Officials
- PRINCIPAL INVESTIGATOR
John Dosik, MD
TKL Research, Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- SCREENING
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 22, 2016
First Posted
April 14, 2016
Study Start
February 1, 2016
Primary Completion
March 1, 2016
Study Completion
March 1, 2016
Last Updated
September 1, 2017
Results First Posted
September 1, 2017
Record last verified: 2017-08