Evaluation of Gynecological Acceptability of 3 Health Care Products

Evaluation of Gynecological Acceptability of 3 Health Care Products (Intimate Gel)

The research was conduct with 3 different products for use in the intimate region in up to 70 research participants, that use the investigational product by 35 ± 2 days. The subjects were follow up throughout the study by a gynecologist for verification of safety, effectiveness and possible adverse events.

At this study, 70 female participants, 18 to 70 years, healthy with complaints of vaginal dryness used the 3 investigational product, each one by 9 days. Between the changes of product use, there were 4 days of wash out. At the 9th day, the participants answered assessment questionnaire.

Inclusion Criteria:

• Health volunteers
• Non-injured mucosa in the test region;
• Agreement to adhere to study procedures and requirements and attend the institute on the day(s) and time(s) determined for the evaluations;
• Ability to consent to their participation in the study;
• Age from 18 to 70 years old;
• Female participants;
• Vaginal dryness (slight minimum) - according to questions from the gynecologist.

Exclusion Criteria:

• Pregnancy or breastfeeding;
• Skin pathology in the area of application of the product;
• Diabetes Mellitus type 1; insulin-dependent diabetes; presence of complications due to diabetes (retinopathy, nephropathy, neuropathy); presence of diabetes-related dermatoses (plantar ulcer, lipoid necrobiosis, annular granuloma, opportunistic infections); history of episodes of hypoglycemia, diabetic ketoacidosis and/or hyperosmolar coma;
• Current use of the following medications for topical or systemic use:

corticosteroids, immunosuppressants and antihistamines;

• Skin diseases: vitiligo, psoriasis, lupus, atopic dermatitis;
• History of reaction to the category of the tested product;
• Other diseases or medications that may directly interfere with the study or endanger the health of the research participant.