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OpenTrials
Completed

NCT Number: NCT02441647

Clinical Study to Prove Safety in Use (Irritability and Sensitization in Genital Mucosa) of an Intimate Lubricating Gel

The purpose of this study is to check the safety under normal conditions of use through the emergence of signs of irritability and sensitization of the genital mucosa.

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Key information

Conditions

Female Dry Genital Mucosa

Age range

25 year–55 year

Sex eligibility

Female

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

  • Female
  • Age between 25 to 55 years old
  • Regular Menstrual Cycle
  • Intact skin in product analysis área
  • No prior reactions to topical products
  • Being a user of products from the same category
  • Reading, understanding, agreement and signature of the informed consent form

Exclusion criteria

  • Pregnancy or risk of pregnancy
  • Lactation
  • Use of anti-inflammatory and immunosuppressive from 30 days up to three months prior to selection;
  • Diseases that cause imune suppression;
  • Endocrine disorders such as thyroid, ovarian or adrenal gland disorders;
  • Any infection in the region where the product will be analyzed diagnosed at enrollment;
  • Other conditions considered by the investigator physician as reasonable for the disqualification of the individual's participation in the study.

Treatment and study plan

KL029 Intimate Lubricant Gel

Device

Primary outcomes

  1. Emergence of signs of irritability and sensitization in the genital mucosa through Wilcoxon test

    Time frame: 40 days

    For the safety assessment, the variables will be evaluated for each experimental period using one-tailed Wilcoxon test to investigate the following hypotheses:

    H0: The median of the results of the variable under study is zero (no irritation) H1: The median of the results of the variable under study is greater than zero (no irritation) The Wilcoxon test is used because it is the ideal to compare variables collected with ordinal scale with a reference value. In this study, the reference value is zero (no irritation).

    The expectation is the absence of positive safety, ie higher scores than zero. If there are positive evidence of (mild, moderate or severe) for parameters erythema, peeling,blistering and swelling, the results are statistically evaluated.

Sponsors and collaborators

Lead sponsor

Kley Hertz S/A

Industry

Registry information

Acronym: CL STD SAF USE

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
May 12, 2015
Registry last updated
Nov 10, 2015

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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