14-Day Cumulative Irritation Patch Test in Subjects With Normal Skin - Chameleon

Church & Dwight

Status: Completed

Conditions: Dermal Irritation

Treatments: Device: Trojan "Chameleon" Personal Lubricant

Study type: Interventional

Funder types: Industry

Identifiers

NCT02737618

ST-7611

Details and patient eligibility

About

to determine the ability of the test article to cause irritation to the skin of humans under controlled patch test conditions

Enrollment: 35 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 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

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
• 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

Trial design

Primary purpose: Screening

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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35 participants in 1 patient group

Healthy subject

Experimental group

Description:

Healthy subjects exposed to Trojan "Chameleon" Personal Lubricant applied by occlusive patch

Treatment:

Device: Trojan "Chameleon" Personal Lubricant