N/A
N=222
Human Repeat Insult Patch Test to Evaluate Personal Lubricants
Erythema · Edema
Bottom Line
View on ClinicalTrials.gov: NCT02737631 ↗Enrolled (actual)
222
Serious AEs
0.0%
Results posted
Sep 2017
Primary outcome: Primary: Number of Patients That Showed Sensitization Reaction to the Test Material at Challenge — 0 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- "Chameleon" Personal Lubricant (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Church & Dwight Company, Inc.
- Primary completion
- Mar 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Patients That Showed Sensitization Reaction to the Test Material at Challenge |
— | — |
Summary
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT02737631). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.