Safety Dermatological Evaluation: Acceptability With Gynecological Follow up - Dermacyd Tina Gel Sweet Flower

Sanofi30 enrolled

Overview

The purpose of this study is to demonstrate the safety of the gynecological formulation in normal and usual usage condition of Dermacyd Tina Gel Sweet Flower.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

Conditions

Hygiene

Interventions

Lactic acid (Dermacid)DRUG

Liquid soup to be applied in the external genital area, in a small quantity, with abundantly rinse after use, during 21 days.

Eligibility

Sex: FEMALEMin age: 10 YearsMax age: 20 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Integral skin test in the region; Exclusion Criteria: * Lactation or gestational risk or gestation; * Use of Anti-inflammatory or immunosuppression drugs 1 month before the study; * Topical medication use at the region to be treated; * Cutaneous disease or active gynecological disease which may interfere in study results; * Personal history of allergic disease at the area to be treated; * Allergic or atopic history; The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Locations (1)

Sanofi-aventis

São Paulo, São Paulo, Brazil

Outcomes

Primary Outcomes

Adverse events and their intensity and their association with the treatment

Time frame: 21 days

Data from ClinicalTrials.gov

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