N/A
N=209
Repeated Insult Patch Test of Personal Lubricants
Erythema · Edema
Bottom Line
View on ClinicalTrials.gov: NCT02297841 ↗Enrolled (actual)
209
Serious AEs
0.0%
Results posted
Oct 2016
Primary outcome: Primary: Number of Participants With Adverse Events as a Measure of Safety and Tolerability — 0 participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Experimental: Novel lubricant Miami Fragrance (Device); Experimental: Novel lubricant Miami no Fragrance (Device); KY Liquid lubricant (Device); Astroglide Gel lubricant (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Church & Dwight Company, Inc.
- Primary completion
- Dec 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Adverse Events as a Measure of Safety and Tolerability |
— | — |
Summary
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT02297841). 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.