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)

Kley Hertz

Status: Unknown

Conditions: Female Dry Genital Mucosa

Treatments: Other: Intimate Lubricant Gel

Study type: Interventional

Funder types: Industry

Identifiers

NCT03007615

Kley Hertz 007

Details and patient eligibility

About

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.

Enrollment: 33 estimated patients

Sex: Female

Ages: 45 to 65 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

33 participants in 1 patient group

Experimental group

Experimental group

Treatment:

Other: Intimate Lubricant Gel