- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00663390
Safety Dermatological Evaluation: Acceptability With Gynecological Follow up - Dermacyd Delicata Pocket BR
January 28, 2009 updated by: Sanofi
Monocentric Study, Phase III, for Safety Dermatological Evaluation: Acceptability With Gynecological Follow up - Dermacyd Delicata Pocket BR
The purpose of this study is to demonstrate the safety of the gynecological formulation in normal and usual usage condition of Dermacyd Delicata Pocket.
Study Overview
Study Type
Interventional
Enrollment (Actual)
30
Phase
- Phase 3
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
-
-
-
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 test in the region;
Exclusion Criteria:
- Lactation or gestational risk or gestation;
- Use of Anti-inflammatory or immunosuppression drugs 1 month before the study;
- Topical medication use at the region to be treated;
- Cutaneous disease or active gynecological 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 all 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: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: I
|
Liquid soup to be applied in the external genital area, in a small quantity, with abundantly rinse after use, during 21 days.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Adverse events and their intensity 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
Investigators
- Study Director: Jaderson Lima, Sanofi-aventis administrative office Brazil
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
December 1, 2007
Primary Completion (Actual)
January 1, 2008
Study Registration Dates
First Submitted
April 18, 2008
First Submitted That Met QC Criteria
April 21, 2008
First Posted (Estimate)
April 22, 2008
Study Record Updates
Last Update Posted (Estimate)
January 29, 2009
Last Update Submitted That Met QC Criteria
January 28, 2009
Last Verified
January 1, 2009
More Information
Terms related to this study
Other Study ID Numbers
- LACAC_L_03743
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.
Clinical Trials on Hygiene
-
SanofiCompleted
-
SanofiCompleted
-
University of WarwickCompleted
Clinical Trials on Lactic acid (Dermacid)
-
SanofiCompleted
-
SanofiCompleted
-
SanofiCompleted
-
SanofiCompleted
-
SanofiCompleted