Dermal and Gynecological Acceptability (Irritability and Sensitization in the Genital Mucosa) of an Investigational Product and Evaluation of Moisture Efficacy by TEWL and Perceived Efficacy. (DERM GYN ACCEP)

To evaluate the safety of an investigational product through the verification of signs of irritability and sensitization of the genital mucosa, as well as the instrumental moisturizing efficacy by TEWL and barrier integrity analysis, in addition to the efficacy perceived by the volunteers.

Study Overview

• Status: Unknown
• Conditions: Female Dry Genital Mucosa
• Intervention / Treatment: Other: Intimate Lubricant Gel

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• Healthy female sex with active sex life;
• Age group: between 45 and 65 years old;
• Menopause for at least six months;
• Whole skin in the region of product analysis;
• No history of reaction to products of the same category
• Understanding, agreement and signature of the Term of Free and Informed Consent.

Exclusion Criteria:

• Gestation or risk of gestation;
• Use of anti-inflammatory / immunosuppressive drugs (in the last 30 days and during the study);
• Active cutaneous pathologies (local and / or disseminated) in the evaluation area;
• Pathologies that cause suppression of immunity, such as diabetes, HIV, etc.;
• Endocrine pathologies such as thyroid disorders, ovarian or adrenal gland disorders;
• Any infection in the region of analysis of the product diagnosed at the time of inclusion;
• Other conditions considered by the investigating physician as reasonable for disqualification of the individual from the study participation.

Study Plan

How is the study designed?

Design Details

• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: Single

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental group	Other: Intimate Lubricant Gel

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Evaluation of the product's efficiency as a moisturizer through subjective evaluation	30 days

Collaborators and Investigators

• Sponsor: Kley Hertz S/A

Study record dates

Study Major Dates

• Study Start: January 1, 2017
• Primary Completion (Anticipated): February 1, 2017

Study Registration Dates

• First Submitted: December 29, 2016
• First Submitted That Met QC Criteria: December 29, 2016
• First Posted (Estimate): January 2, 2017

Study Record Updates

• Last Update Posted (Estimate): January 2, 2017
• Last Update Submitted That Met QC Criteria: December 29, 2016
• Last Verified: December 1, 2016

More Information

Terms related to this study

• Other Study ID Numbers: Kley Hertz 007