Dermatological Evaluation of Topic Compatibility-Dermacyd Tina Gel Sweet Flower
This study has been completed.
Information provided by:
First received: April 23, 2008
Last updated: January 27, 2009
Last verified: January 2009
The purpose of this study is to demonstrate the absence of irritation potential (primary dermic irritability and cumulated dermic irritability) and allergy (sensibilization) of the product Dermacyd Tina Gel Sweet Flower.
Drug: Lactic acid (Dermacid)
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
||Study for Dermatological Evaluation of Topic Compatibility (Primary and Accumulated Dermical Irritability, Dermical Sensitivity) of Dermacyd Tina Gel Sweet Flower.
Primary Outcome Measures:
- The absence of primary and accumulated dermal irritability and dermal sensitivity will be evaluated using International Contact Dermatitis Research Group (ICDRG) scale. [ Time Frame: six weeks ] [ Designated as safety issue: Yes ]
| Study Start Date:
| Primary Completion Date:
||January 2008 (Final data collection date for primary outcome measure)
|Ages Eligible for Study:
||18 Years to 60 Years
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- Phototype Skin I,II, III e IV
- Integral skin test in the region
- Lactation or gestation
- Use of Antiinflammatory and/or immunosuppression drugs
- 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.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
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: NCT00668668
|São Paulo, Brazil |
||Sanofi-aventis administrative office Brazil
No publications provided
||GMA-CO/Medical Director, sanofi-aventis administrative office France
History of Changes
|Other Study ID Numbers:
|Study First Received:
||April 23, 2008
||January 27, 2009
||Brazil: National Health Surveillance Agency
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on July 01, 2015