- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00783640
Dermacyd Femina (Lactic Acid) Pocket BR - Photo Evaluation
December 18, 2008 updated by: Sanofi
Dermatological Evaluation of the Photo Irritation and Photo Sensitivity Potential for Dermacyd Femina Pocket BR.
To demonstrate the absence of photoirritation and photosensitization potential of the product Dermacyd Femina (Lactic Acid) Pocket BR.
Study Overview
Study Type
Interventional
Enrollment (Actual)
27
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
-
-
-
Sao Paulo, Brazil
- Sanofi-Aventis Administrative Office
-
-
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:
- Age between 18 and 60 years old;
- Phototype Skin I,II, III e IV
- Integral skin test in the region;
- Willingness in following the study procedures and to be present in the clinic at the days and scheduled time for medical evaluations and for application of occlusion;
Exclusion criteria:
- Lactation or gestation
- Use of Antiinflammatory and/or immunosuppression drugs one month before the study;
- Personnel history of atopy;
- History of sensitivity or irritation for topic products;
- Active cutaneous disease;
- Use of new drugs or cosmetics during the study;
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: 1
Lactic Acid
|
Drug: Lactic Acid (Dermacyd Femina)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
The sensibility will be evaluated according to the skin type.
Time Frame: Throughout the study
|
Throughout the study
|
The photo irritation test and the photosensitivity will be measured using UVA irradiation and evaluated according International Contact Dermatitis Research Group (ICDRG) scale.
Time Frame: Throughout the study
|
Throughout the study
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
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
October 1, 2008
Primary Completion (Actual)
November 1, 2008
Study Registration Dates
First Submitted
October 31, 2008
First Submitted That Met QC Criteria
October 31, 2008
First Posted (Estimate)
November 2, 2008
Study Record Updates
Last Update Posted (Estimate)
December 19, 2008
Last Update Submitted That Met QC Criteria
December 18, 2008
Last Verified
December 1, 2008
More Information
Terms related to this study
Other Study ID Numbers
- LACAC_L_04371
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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