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Clinical Trials/EUCTR2014-004666-14-Outside-EU/EEA
EUCTR2014-004666-14-Outside-EU/EEA
Active, not recruiting
Not Applicable

Safety Dermatological Evaluation: acceptability with pediatric follow up – Dermacyd Infantile LACAC_L_04678

Sanofi0 sites31 target enrollmentMarch 25, 2015
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ConditionsHealthy volunteers (hygiene)MedDRA version: 17.1Level: PTClassification code 10053339Term: Routine health maintenanceSystem Organ Class: 10042613 - Surgical and medical proceduresTherapeutic area: Not possible to specify

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Healthy volunteers (hygiene)
Sponsor
Sanofi
Enrollment
31
Status
Active, not recruiting
Last Updated
11 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
March 25, 2015
End Date
TBD
Last Updated
11 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Sponsor
Sanofi

Eligibility Criteria

Inclusion Criteria

  • •Healthy female and male volunteers, aged between 0 and 12 years old; intact skin in the area where the test product will be applied (body); 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) no
  • •F.1\.2\.1 Number of subjects for this age range
  • •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;
  • •Use of Anti\-inflammatory, immunossupression or anti\-histaminic
  • •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;

Outcomes

Primary Outcomes

Not specified

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