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.

Not Applicable

• Conditions: Female Dry Genital Mucosa
• Interventions: Other: Intimate Lubricant Gel

• Registration Number: NCT03007615
• Lead Sponsor: Kley Hertz S/A

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2016-12
• Study First Submitted: 2016-12-29
• Study First Submitted QC: 2016-12-29
• Last Update Submitted: 2016-12-29
• Study Start: 2017-01
• Study First Posted: 2017-01-02
• Last Update Posted: 2017-01-02
• Primary Completion: 2017-02

Recruitment & Eligibility

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

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Experimental group	Intimate Lubricant Gel	-

Primary Outcome Measures

Name	Time	Method
Evaluation of the product's efficiency as a moisturizer through subjective evaluation	30 days