Dermacyd PH_DETINLYN Tangerine Mix (Lactic Acid) - Safety.

Phase 3CompletedNCT00785642

Sanofi30 enrolled

Overview

To prove the safety of the gynaecological formulation in normal conditions of use.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

Conditions

Hygiene

Interventions

Dermacyd PH_DETINLYN Tangerine Mix (Lactic Acid)DRUG

Eligibility

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

Medical Language ↔ Plain English

Inclusion criteria: * Integral skin test in the region; * Use of cosmetic product of the same category; * Willingness in following the study procedures and to be present in the clinic at the days and scheduled time; Exclusion criteria: * Lactation or gestational risk or gestation; * Use of Anti-inflammatory, immunosuppression or antihistaminic drugs; * Atopic antecedent or allergic to cosmetic product; * Active cutaneous disease in the evaluation area; * Diseases which cause immunology decrease, such as diabetes and HIV; * Endocrinal pathologies; * Intense solar exposure 15 days before the evaluation; * Treatment until four months before the selection 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 Administrative Office

São Paulo, Brazil

Outcomes

Primary Outcomes

The absence of irritation and the good acceptability will be evaluated using one specific scale which describes the intensity of the reaction.

Time frame: From the treatment start to the end of the study

Data from ClinicalTrials.gov

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