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

Kley Hertz

Status: Completed

Conditions: Female Dry Genital Mucosa

Treatments: Device: KL029 Intimate Lubricant Gel

Study type: Interventional

Funder types: Industry

Identifiers

NCT02441647

KLEY HERTZ-003

Details and patient eligibility

About

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.

Enrollment: 33 patients

Sex: Female

Ages: 25 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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.

Trial design

33 participants in 1 patient group

Experimental group

Experimental group

Treatment:

Device: KL029 Intimate Lubricant Gel