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

Not Applicable

Completed

• Conditions: Female Dry Genital Mucosa
• Interventions: Device: KL029 Intimate Lubricant Gel

• Registration Number: NCT02441647
• Lead Sponsor: Kley Hertz S/A

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-04-15
• Study First Submitted QC: 2015-05-07
• Study First Posted: 2015-05-12
• Study Start: 2015-06
• Primary Completion: 2015-06
• Study Completion: 2015-07
• Status Verified: 2015-11
• Last Update Submitted: 2015-11-09
• Last Update Posted: 2015-11-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 33

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Experimental group	KL029 Intimate Lubricant Gel	-

Primary Outcome Measures

Name	Time	Method
Emergence of signs of irritability and sensitization in the genital mucosa through Wilcoxon test	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.