Repeated Insult Patch Test of Personal Lubricants

Church & Dwight

Status: Completed

Conditions: Edema; Erythema

Treatments: Device: Astroglide Gel lubricant; Device: Experimental: Novel lubricant Miami Fragrance; Device: KY Liquid lubricant; Device: Experimental: Novel lubricant Miami no Fragrance

Study type: Interventional

Funder types: Industry

Identifiers

NCT02297841

ST-7554

Details and patient eligibility

About

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.

Enrollment: 209 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Screening

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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209 participants in 1 patient group

Human Repeat Insult Patch Test

Experimental group

Description:

Approximately 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.

Treatment:

Device: Experimental: Novel lubricant Miami Fragrance

Device: Astroglide Gel lubricant

Device: KY Liquid lubricant

Device: Experimental: Novel lubricant Miami no Fragrance