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OpenTrials
Completed

NCT Number: NCT02737631

Human Repeat Insult Patch Test to Evaluate Personal Lubricants

The purpose of this test is to evaluate the sensitizing potential of a personal lubricant, as a result of repeated occlusive patch. The intervention will be applied for a total of 9 induction applications, followed by an approximately 2 week rest period, then followed by a 24-72 hour Challenge applications.

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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–69 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Harrison Research Laboratories, Inc.

Union, New Jersey, 07083, United States

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • good health as determined from screener
  • signed and dated informed consent
  • signed and dated HIPAA Form

Exclusion criteria

  • subjects on test at any other research laboratory or clinic
  • known allergy or sensitivity to cosmetics and toiletries, including sunscreens, adhesives and/or topical drugs
  • pre-existing dermatologic conditions which have been diagnosed by a medical professional (e.g. psoriasis, eczema, etc.) which would interfere with this study
  • pre-existing other medical conditions (e.g. adult asthma, diabetes).
  • treatment with antibiotics, antihistamines or corticosteroids within two weeks prior to initiation of the test
  • chronic medication which could affect the results of the study (e.g., insulin, corticosteroids, antihistimines, steroidal or non-steroidal anti-inflammatory drugs [except for therapeutic maintenance dosage of aspirin], antibiotics, steroid inhalers, etc.)
  • known pregnant or nursing women

Treatment and study plan

"Chameleon" Personal Lubricant

Device

Primary outcomes

  1. Number of Patients That Showed Sensitization Reaction to the Test Material at Challenge

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

Sponsors and collaborators

Lead sponsor

Church & Dwight Company, Inc.

Industry

Registry information

Acronym: HRIPT

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Apr 14, 2016
Registry last updated
Apr 15, 2021

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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