Repeated Insult Patch Test of Personal Lubricants

NCT ID: NCT02297841

Last Updated: 2016-10-05

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

209 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-11-30

Study Completion Date

2014-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Erythema Edema

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Human Repeat Insult Patch Test

Approximately 0.2ml of each intervention (Experimental: Novel lubricant Miami Fragrance, Experimental: Novel lubricant Miami no Fragrance, KY Liquid lubricant, Astroglide Gel lubricant) was applied to an occlusive patch and applied to participant's back.

Group Type EXPERIMENTAL

Experimental: Novel lubricant Miami Fragrance

Intervention Type DEVICE

Experimental: Novel lubricant Miami no Fragrance

Intervention Type DEVICE

KY Liquid lubricant

Intervention Type DEVICE

Astroglide Gel lubricant

Intervention Type DEVICE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Experimental: Novel lubricant Miami Fragrance

Intervention Type DEVICE

Experimental: Novel lubricant Miami no Fragrance

Intervention Type DEVICE

KY Liquid lubricant

Intervention Type DEVICE

Astroglide Gel lubricant

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Church & Dwight Company, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

ST-7554

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Postcoital Testing of the SILCS Diaphragm
NCT00561613 COMPLETED PHASE1
Study of UC-781 Vaginal Microbicide
NCT00132444 COMPLETED PHASE1
A Study of BufferGel in Women
NCT00000927 COMPLETED PHASE1