Safety evaluation: Gynecological liquid soap Dermacyd PH_DETINLYN tangerine mix.

Conditions: Healthy volunteers (hygiene)
MedDRA version: 17.1Level: PTClassification code 10053339Term: Routine health maintenanceSystem Organ Class: 10042613 - Surgical and medical procedures
Therapeutic area: Not possible to specify

Registration Number: EUCTR2014-004664-38-Outside-EU/EEA

Lead Sponsor: Sanofi

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: A

Sex: Female

Target Recruitment: 31

Inclusion Criteria

Healthy female volunteers; aged between 10 and 20 years old; intact skin in the area where the test product will be applied; use of cosmetic products of the same category; willingness in following the study procedures; to be able to attend the study visits;
Are the trial subjects under 18? yes
Number of subjects for this age range: 31
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 3
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

•Pregnancy or risk of pregnancy;
•Lactation
•Use of Anti-inflammatory, immunossupression or anti-histaminic drugs;
•Atopic or allergic history to cosmetic products;
•Active cutaneous disease in the tested area;
•Disease that causes decrease of immunity, such as diabetes and HIV;
•Endocrine pathologies;
•Intense solar exposure 15 days before the evaluation;
•Any treatment in the four months before the selection;

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To prove the safety of the gynecological formulation in normal and usual use conditions.;Secondary Objective: Not Applicable;Primary end point(s): - Number of subjects with skin reaction in the tested region.;Timepoint(s) of evaluation of this end point: 21 days

Secondary Outcome Measures