- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00497783
Acceptability Lactoserum (Dermacyd Delicata - New Fragrance)
May 19, 2008 updated by: Sanofi
Safety Dermatological Evaluation of the Acceptability With Gynecological Follow up for Dermacyd Femina Delicata
The purpose of this study is to demonstrate the safety of the gynecological formulation in normal and usual usage condition of Dermacyd Femina Delicata.
Study Overview
Study Type
Interventional
Enrollment (Anticipated)
30
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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São Paulo, Brazil
- Sanofi-Aventis
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 60 years (ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- Integral skin in the tested region
Exclusion Criteria:
- Pregnancy or breastfeeding women
- Use of Anti-inflammatory or immune-suppression drugs
- Topical medication use at the tested region
- Active cutaneous gynaecological disease which may interfere in study results
- Personal history of allergic disease at the area to be treated
- Allergic or atopic history
The above information is not intended to contain considerations relevant to a patient's potential participation in a clinical trial.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: SUPPORTIVE_CARE
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Clinical and local tolerability
Time Frame: 21 days
|
21 days
|
Adverse events and their association with the treatment.
Time Frame: 21 days
|
21 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2007
Study Registration Dates
First Submitted
July 6, 2007
First Submitted That Met QC Criteria
July 6, 2007
First Posted (ESTIMATE)
July 9, 2007
Study Record Updates
Last Update Posted (ESTIMATE)
May 20, 2008
Last Update Submitted That Met QC Criteria
May 19, 2008
Last Verified
May 1, 2008
More Information
Terms related to this study
Other Study ID Numbers
- LACTO_L_02949
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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