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

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.

Study Overview

• Status: Completed
• Conditions: Female Dry Genital Mucosa
• Intervention / Treatment: Device: KL029 Intimate Lubricant Gel

• Study Type: Interventional
• Enrollment (Actual): 33
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years to 55 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: SINGLE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Experimental group	Device: KL029 Intimate Lubricant Gel

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Emergence of signs of irritability and sensitization in the genital mucosa through Wilcoxon test	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.	40 days

Collaborators and Investigators

• Sponsor: Kley Hertz S/A

Study record dates

Study Major Dates

• Study Start: June 1, 2015
• Primary Completion (ACTUAL): June 1, 2015
• Study Completion (ACTUAL): July 1, 2015

Study Registration Dates

• First Submitted: April 15, 2015
• First Submitted That Met QC Criteria: May 7, 2015
• First Posted (ESTIMATE): May 12, 2015

Study Record Updates

• Last Update Posted (ESTIMATE): November 10, 2015
• Last Update Submitted That Met QC Criteria: November 9, 2015
• Last Verified: November 1, 2015

More Information

Terms related to this study

• Other Study ID Numbers: KLEY HERTZ-003