Safety Dermatological Evaluation: Acceptability With Gynecological Follow up - Dermacyd Delicata Pocket BR

Sanofi

Status and phase: Completed; Phase 3

Conditions: Hygiene

Treatments: Drug: Lactic acid (Dermacid)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00663390

LACAC_L_03743

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 Delicata Pocket.

Enrollment: 30 patients

Sex: Female

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

I

Experimental group

Treatment:

Drug: Lactic acid (Dermacid)