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Repeated Insult Patch Test of Personal Lubricants

Primary Purpose

Erythema, Edema

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Experimental: Novel lubricant Miami Fragrance
Experimental: Novel lubricant Miami no Fragrance
KY Liquid lubricant
Astroglide Gel lubricant
Sponsored by
Church & Dwight Company, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Erythema

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Human Repeat Insult Patch Test

    Arm Description

    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.

    Outcomes

    Primary Outcome Measures

    Number of Participants With Adverse Events as a Measure of Safety and Tolerability

    Secondary Outcome Measures

    Full Information

    First Posted
    November 17, 2014
    Last Updated
    September 14, 2016
    Sponsor
    Church & Dwight Company, Inc.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02297841
    Brief Title
    Repeated Insult Patch Test of Personal Lubricants
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2016
    Overall Recruitment Status
    Completed
    Study Start Date
    November 2014 (undefined)
    Primary Completion Date
    December 2014 (Actual)
    Study Completion Date
    December 2014 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Church & Dwight Company, Inc.

    4. Oversight

    5. Study Description

    Brief 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Erythema, Edema

    7. Study Design

    Primary Purpose
    Screening
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    209 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Human Repeat Insult Patch Test
    Arm Type
    Experimental
    Arm Description
    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.
    Intervention Type
    Device
    Intervention Name(s)
    Experimental: Novel lubricant Miami Fragrance
    Intervention Type
    Device
    Intervention Name(s)
    Experimental: Novel lubricant Miami no Fragrance
    Intervention Type
    Device
    Intervention Name(s)
    KY Liquid lubricant
    Intervention Type
    Device
    Intervention Name(s)
    Astroglide Gel lubricant
    Primary Outcome Measure Information:
    Title
    Number of Participants With Adverse Events as a Measure of Safety and Tolerability
    Time Frame
    24, 48, and 72 hours after patch application

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    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

    12. IPD Sharing Statement

    Learn more about this trial

    Repeated Insult Patch Test of Personal Lubricants

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