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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02297841
Other study ID # ST-7554
Secondary ID
Status Completed
Phase N/A
First received November 17, 2014
Last updated February 4, 2015
Start date November 2014
Est. completion date December 2014

Study information

Verified date February 2015
Source Church & Dwight Company, Inc.
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 201
Est. completion date December 2014
Est. primary completion date December 2014
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 70 Years
Eligibility Inclusion Criteria:

- 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

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.

- 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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Screening


Related Conditions & MeSH terms


Intervention

Device:
Experimental: Novel lubricant Miama w/ frag

Experimental: Novel Miami w/o frag

KY Liquid lubricant

Astroglide Gel lubricant


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Church & Dwight Company, Inc.

Outcome

Type Measure Description Time frame Safety issue
Primary Number of Participants with Adverse Events as a Measure of Safety and Tolerability Change from baseline to skin sensitization graded at 24, 48, and 72 hours after patch application Yes
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