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.

NCT ID: NCT03007615

Last Updated: 2017-01-02

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 33 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-01-31

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.

Conditions

Female Dry Genital Mucosa

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Blinding Strategy: SINGLE

Study Groups

Experimental group

Group Type: EXPERIMENTAL

Intimate Lubricant Gel

Intervention Type: OTHER

Interventions

Intimate Lubricant Gel

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Kley Hertz S/A

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

Kley Hertz 007

Identifier Type: -

Identifier Source: org_study_id