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

NCT02441647 | Completed

• 1 other identifier: KLEY HERTZ-003
• Study Type: interventional
• Target: 33
• Locations: 0 countries
• Sites: N/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.

Conditions

Female Dry Genital Mucosa

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Experimental group

EXPERIMENTAL

Device: KL029 Intimate Lubricant Gel

Interventions

KL029 Intimate Lubricant Gel DEVICE

Experimental group

Eligibility Criteria

• Age: 25 Years - 55 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Kley Hertz S/A: lead

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 15, 2015
• First Posted: May 12, 2015
• Study Start: June 1, 2015
• Primary Completion: June 1, 2015
• Study Completion: July 1, 2015
• Last Updated: November 10, 2015

Record last verified: 2015-11