Acceptability Dermacyd Delicata - New Fragrance - Lactoserum - Hygiene

Hygiene Clinical Trial

Official title:

Safety Dermatological Evaluation: Acceptability With Gynecological Follow up - Dermacyd Delicata New Fragrance

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00370162
• Other study ID #: LACTO_L_01839
• Status: Completed
• Phase: Phase 3
• First received: August 29, 2006
• Last updated: May 15, 2008
• Start date: June 2006

Study information

• Verified date: May 2008
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Health Surveillance Agency
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to demonstrate the safety of the gynaecological formulation in normal and usual usage condition.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• Integral skin in the tested region

Exclusion Criteria:

• Pregnancy or breastfeeding women

• Use of antiinflammatory or immunosuppression drugs

• Topical medication use at the tested region

• Active cutaneous gynaecological disease

• Personal history of allergic disease at the area to be treated

• Allergic or atopic history

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hygiene

Intervention

Drug:
• lactoserum

Locations

Country	Name	City	State
Brazil	Sanofi-Aventis	São Paulo

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adverse Events and its association with the drug in study