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OpenTrials
Completed

NCT Number: NCT02297841

Repeated Insult Patch Test of Personal Lubricants

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.

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Key information

Conditions

Erythema Edema Pathological Conditions, Signs and Symptoms Signs and Symptoms Skin Diseases Skin Manifestations Skin and Connective Tissue Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Experimental: Novel lubricant Miami Fragrance

Device

Experimental: Novel lubricant Miami no Fragrance

Device

KY Liquid lubricant

Device

Astroglide Gel lubricant

Device

Primary outcomes

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

    Time frame: 24, 48, and 72 hours after patch application

Sponsors and collaborators

Lead sponsor

Church & Dwight Company, Inc.

Industry

Registry information

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Nov 21, 2014
Registry last updated
Oct 5, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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