Acceptability Dermacyd Wipes - Lactoserum - Hygiene

Sanofi

Status and phase: Completed; Phase 3

Conditions: Hygiene

Treatments: Drug: lactoserum

Study type: Interventional

Funder types: Industry

Identifiers

NCT00397527

LACTO_L_01810

Details and patient eligibility

About

The purpose of this study is to demonstrate the safety of the gynecological formulation in normal and usual usage condition of Dermacyd Wipes

Sex: Female

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

The following information on clinical trials is provided for information purposes only to allow patients and physicians to have an initial discussion about the trial. This information is not intended to be complete information about the trial, to contain all considerations that may be relevant to potential participation in the trial, or to replace the advice of a personal physician or health professional.

Main criteria are listed hereafter:

Inclusion Criteria:

• Integral skin in the tested region

Exclusion Criteria:

• Pregnancy or breastfeeding women;
• Use of antiinflammatory or immunosuppression drugs;
• Topical medication use at the region to be treated;
• Cutaneous disease or active gynaecological disease which may interfer in study results;
• Personal history of allergic disease at the area to be treated;
• Allergic or atopic history.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)