- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00705744
Dermacyd Femina (Lactic Acid) - Photo Dermatological Evaluation of the Irritation and Sensitivity Potential.
April 14, 2009 updated by: Sanofi
Dermatological Evaluation of the Photo Irritation and Photo Sensitivity Potential for Dermacyd Femina.
To prove the absence of photo irritation and photo sensitivity potential of the product Dermacyd Femina.
Study Overview
Study Type
Interventional
Enrollment (Actual)
26
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:
- Phototype Skin II and III;
- Integral skin test in the region;
Exclusion Criteria:
- Lactation or gestation;
- Use of Anti-inflammatory and/or immuno-suppression drugs 15 days before the selection;
- Diseases which can cause immunity decrease, such as HIV, diabetes;
- Use of drug photosensitizer;
- History of sensitivity or irritation for topic products;
- Active cutaneous disease which can change the study results;
- History or photodermatosis active;
- Family or personal antecedent of cutaneous photoinduced neoplasias;
- Presence of a precursor lesion of cutaneous neoplasia, such as nevus melanocyte and keratoses actinium;
- Intense solar exposure in the study area;
- 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: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: I
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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: 5 weeks
|
5 weeks
|
The sensibility will be evaluated according to the skin type.
Time Frame: 5 weeks
|
5 weeks
|
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
April 1, 2008
Primary Completion (Actual)
May 1, 2008
Study Registration Dates
First Submitted
June 25, 2008
First Submitted That Met QC Criteria
June 25, 2008
First Posted (Estimate)
June 26, 2008
Study Record Updates
Last Update Posted (Estimate)
April 15, 2009
Last Update Submitted That Met QC Criteria
April 14, 2009
Last Verified
April 1, 2009
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- LACAC_L_03982
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
-
SanofiCompleted
-
University of WarwickCompleted
Clinical Trials on Lactic acid (Dermacyd Femina)
-
SanofiCompleted
-
SanofiCompletedBacterial VaginosisBrazil