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Dermacyd Femina (Lactic Acid) Pocket BR - Photo Evaluation
This study has been completed.
Sponsor:
Sanofi
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00783640
First received: October 31, 2008
Last updated: December 18, 2008
Last verified: December 2008
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Purpose
To demonstrate the absence of photoirritation and photosensitization potential of the product Dermacyd Femina (Lactic Acid) Pocket BR.
| Condition | Intervention | Phase |
|---|---|---|
| Hygiene | Drug: Lactic Acid | Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Supportive Care |
| Official Title: | Dermatological Evaluation of the Photo Irritation and Photo Sensitivity Potential for Dermacyd Femina Pocket BR. |
Resource links provided by NLM:
Further study details as provided by Sanofi:
Primary Outcome Measures:
- 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 ]
- The sensibility will be evaluated according to the skin type. [ Time Frame: Throughout the study ]
| Enrollment: | 27 |
| Study Start Date: | October 2008 |
| Primary Completion Date: | November 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
Lactic Acid
|
Drug: Lactic Acid
Drug: Lactic Acid (Dermacyd Femina)
|
Eligibility| Ages Eligible for Study: | 18 Years to 60 Years (Adult) |
| Sexes Eligible for Study: | Female |
| Accepts Healthy Volunteers: | Yes |
Criteria
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.
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00783640
Please refer to this study by its ClinicalTrials.gov identifier: NCT00783640
Locations
| Brazil | |
| Sanofi-Aventis Administrative Office | |
| Sao Paulo, Brazil | |
Sponsors and Collaborators
Sanofi
Investigators
| Study Director: | Jaderson Lima | Sanofi |
More Information
Additional Information:
| Responsible Party: | Medical Affairs Study Director, sanofi-aventis |
| ClinicalTrials.gov Identifier: | NCT00783640 History of Changes |
| Other Study ID Numbers: |
LACAC_L_04371 |
| Study First Received: | October 31, 2008 |
| Last Updated: | December 18, 2008 |
ClinicalTrials.gov processed this record on September 19, 2017