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Dermacyd PH_DETINLYN (Lactic Acid) Tangerine Mix - Compatibility
This study has been completed.
Sponsor:
Sanofi
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00786097
First received: November 4, 2008
Last updated: August 21, 2009
Last verified: August 2009
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Purpose
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 PHDETINLYN Tangerine Mix.None.
| Condition | Intervention | Phase |
|---|---|---|
| Hygiene | Drug: Dermacyd PH_DETINLYN (Lactic Acid) | Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Supportive Care |
| Official Title: | Study for Dermatological Evaluation of Topic Compatibility (Primary and Accumulated Dermical Irritability, Dermical Sensitivity) of Dermacyd PH_DETINLYN (Lactic Acid) Tangerine Mix |
Resource links provided by NLM:
Further study details as provided by Sanofi:
Primary Outcome Measures:
- The absence of primary and accumulated dermical irritability and dermical sensitivity will be evaluated using International Contact Dermatitis Research Group (ICDRG) scale. [ Time Frame: Throughout the study ]
| Enrollment: | 53 |
| Study Start Date: | July 2008 |
| Study Completion Date: | September 2008 |
| Primary Completion Date: | September 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
Dermacyd PH_DETINLYN (Lactic Acid)
|
Drug: Dermacyd PH_DETINLYN (Lactic Acid) |
Eligibility| Ages Eligible for Study: | 18 Years to 60 Years (Adult) |
| Sexes Eligible for Study: | Female |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion criteria:
- 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 inclusion:
- Lactation or gestation
- Use of Antiinflammatory and/or immunossupression 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.
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: NCT00786097
Please refer to this study by its ClinicalTrials.gov identifier: NCT00786097
Locations
| Brazil | |
| Sanofi-Aventis Administrative Office | |
| Sao Paulo, Brazil | |
Sponsors and Collaborators
Sanofi
Investigators
| Study Director: | Jaderson Lima | Sanofi |
More Information
| Responsible Party: | Medical Affairs Study Director, sanofi-aventis |
| ClinicalTrials.gov Identifier: | NCT00786097 History of Changes |
| Other Study ID Numbers: |
LACAC_L_04305 |
| Study First Received: | November 4, 2008 |
| Last Updated: | August 21, 2009 |
ClinicalTrials.gov processed this record on August 16, 2017