Safety evaluation: gynecological liquid soap Dermacyd DETINLYN SweetFlower.
- 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
- EUCTR2014-004662-26-Outside-EU/EEA
- Lead Sponsor
- Sanofi
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- A
- Sex
- Female
- Target Recruitment
- 32
Healthy female volunteers; aged between 10 and 20 years old; intact skin in the area where the test product will be applied; use the same category of cosmetic products; wllingness 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 5
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, immunosuppression or anti-histaminic
drugs;
- Atopic/allergic antecedent with cosmetic product;
- Active cutaneous disease in the tested area;
- Diseases which cause immunology decrease, such as diabetes and
HIV;
- Endocrinal 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 liquid soap formulation in<br>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