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Completed

NCT Number: NCT02737618

14-Day Cumulative Irritation Patch Test in Subjects With Normal Skin - Chameleon

to determine the ability of the test article to cause irritation to the skin of humans under controlled patch test conditions

Completed

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Key information

Conditions

Dermal Irritation

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

TKL Research Inc

Fair Lawn, New Jersey, 07410, United States

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • male or female, 18-70 years of age, in general good health
  • normal skin
  • 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
  • of any skin type or race providing the skin pigmentation will allow discernment of erythema
  • agree to complete a medical history and concomitant medication form
  • read, understand and sign informed consent

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
  • have a known sensitivity to cosmetics, skin care test articles, or topical drugs as related to the test article being evaluated
  • are females who are pregnant or breastfeeding or become pregnant

Treatment and study plan

Trojan "Chameleon" Personal Lubricant

Device

silicone base with sensate

Primary outcomes

  1. Number of Subjects That Showed Erythema Based on 5 Point Scoring Scale

    Time frame: 14 days

  2. Number of Subjects That Showed Edema Based on the 5 Point Scoring Scale

    Time frame: 14 days

Sponsors and collaborators

Lead sponsor

Church & Dwight Company, Inc.

Industry

Registry information

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Apr 14, 2016
Registry last updated
Sep 1, 2017

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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