Human Repeat Insult Patch Test to Evaluate Personal Lubricants (HRIPT)

Church & Dwight

Status

Completed

Conditions

Edema

Erythema

Treatments

Device: "Chameleon" Personal Lubricant

Study type

Interventional

Funder types

Industry

Identifiers

NCT02737631

ST-7619

Details and patient eligibility

About

The purpose of this test is to evaluate the sensitizing potential of a personal lubricant, as a result of repeated occlusive patch. The intervention will be applied for a total of 9 induction applications, followed by an approximately 2 week rest period, then followed by a 24-72 hour Challenge applications.

Enrollment

222 patients

Sex

All

Ages

18 to 69 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

good health as determined from screener
signed and dated informed consent
signed and dated HIPAA Form

Exclusion criteria

subjects on test at any other research laboratory or clinic
known allergy or sensitivity to cosmetics and toiletries, including sunscreens, adhesives and/or topical drugs
pre-existing dermatologic conditions which have been diagnosed by a medical professional (e.g. psoriasis, eczema, etc.) which would interfere with this study
pre-existing other medical conditions (e.g. adult asthma, diabetes).
treatment with antibiotics, antihistamines or corticosteroids within two weeks prior to initiation of the test
chronic medication which could affect the results of the study (e.g., insulin, corticosteroids, antihistimines, steroidal or non-steroidal anti-inflammatory drugs [except for therapeutic maintenance dosage of aspirin], antibiotics, steroid inhalers, etc.)
known pregnant or nursing women