N/A
N=43
14-Day Cumulative Irritation Patch Test in Subjects With Normal Skin - Chameleon
Dermal Irritation
Bottom Line
View on ClinicalTrials.gov: NCT02737618 ↗Enrolled (actual)
43
Serious AEs
0.0%
Results posted
Sep 2017
Primary outcome: Primary: Number of Subjects That Showed Erythema Based on 5 Point Scoring Scale — 0 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Trojan "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 Subjects That Showed Erythema Based on 5 Point Scoring Scale |
— | — |
| PRIMARY Number of Subjects That Showed Edema Based on the 5 Point Scoring Scale |
— | — |
Summary
to determine the ability of the test article to cause irritation to the skin of humans under controlled patch test conditions
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT02737618). 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.