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

Female Dry Genital Mucosa Clinical Trial

— CL STD SAF USE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02441647
• Other study ID #: KLEY HERTZ-003
• Status: Completed
• Phase: N/A
• First received: April 15, 2015
• Last updated: November 9, 2015
• Start date: June 2015
• Est. completion date: July 2015

Study information

• Verified date: November 2015
• Source: Kley Hertz S/A
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: July 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 25 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Female Dry Genital Mucosa

Intervention

Device:
• KL029 Intimate Lubricant Gel

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Kley Hertz S/A

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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