Repeated Insult Patch Test of Personal Lubricants

Skin Irritation Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02297841
• Other study ID #: ST-7554
• 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

• Skin Irritation

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