Safety evaluation: gynecological liquid soap Dermacyd Tina Gel Sweet Flower
- Conditions
- Healthy volunteers (hygiene)MedDRA version: 17.1Level: PTClassification code 10053339Term: Routine health maintenanceSystem Organ Class: 10042613 - Surgical and medical proceduresTherapeutic area: Not possible to specify
- Registration Number
- EUCTR2014-004660-37-Outside-EU/EEA
- Lead Sponsor
- Sanofi
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- A
- Sex
- Female
- Target Recruitment
- 31
Healthy female volunteers; aged between 10 and 20 years old; intact skin in the area where the test product will be applied; 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: 27
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 4
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
- Pregnancy or risk of pregnancy;
- Lactation;
- Use of anti-inflammatory and / or immunosuppressive drugs in the previous month of the study enrollment;
- Use of topical medications in the area where the test product will be applied;
- Active skin or gynecological pathologies that may interfere in the study evaluation;
- History of allergic diseases in the region where the test product will be applied;
- Atopic or allergic history.
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
Name Time Method Secondary end point(s): Not applicable;Timepoint(s) of evaluation of this end point: Not applicable