Repeated Insult Patch Test of Personal Lubricants
1 other identifier
interventional
209
0 countries
N/A
Brief Summary
Determine the ability of the study material (personal lubricant) to cause sensitization by repeated topical application 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 P75+ for not_applicable
Started Nov 2014
Shorter than P25 for not_applicable
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
November 1, 2014
CompletedFirst Submitted
Initial submission to the registry
November 17, 2014
CompletedFirst Posted
Study publicly available on registry
November 21, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2014
CompletedResults Posted
Study results publicly available
October 5, 2016
CompletedOctober 5, 2016
September 1, 2016
1 month
November 17, 2014
July 19, 2016
September 14, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Number of Participants With Adverse Events as a Measure of Safety and Tolerability
24, 48, and 72 hours after patch application
Study Arms (1)
Human Repeat Insult Patch Test
EXPERIMENTALApproximately 0.2ml of each intervention (Experimental: Novel lubricant Miami Fragrance, Experimental: Novel lubricant Miami no Fragrance, KY Liquid lubricant, Astroglide Gel lubricant) was applied to an occlusive patch and applied to participant's back.
Interventions
Eligibility Criteria
You may qualify if:
- In general good health
- 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
- Are of any skin type or race, providing the skin pigmentation will allow discernment of erythema
- Complete a medical screening procedure
- Read, understand, and sign an informed consent agreement
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.
- Are females who are pregnant, planning on getting pregnant during the study, or breast-feeding
- Have a known sensitivity for cosmetics, skin care products, topical drugs, or any other type of the products, as related to the material being evaluated
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Annahita Ghassemi
- Organization
- Church & Dwight Co., 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
November 17, 2014
First Posted
November 21, 2014
Study Start
November 1, 2014
Primary Completion
December 1, 2014
Study Completion
December 1, 2014
Last Updated
October 5, 2016
Results First Posted
October 5, 2016
Record last verified: 2016-09