Dermacyd Teen Care Tangerina Mix - Compatibility
Study for Dermatological Evaluation of Topic Compatibility (Primary and Accumulated Dermal Irritability, Dermal Sensitivity) of Dermacyd Teen Care Tangerina Mix .
1 other identifier
interventional
51
1 country
1
Brief Summary
The purpose of this study is to demonstrate the absence of irritation potential (primary dermal irritability and cumulated dermal irritability) and allergy (sensibilization) of the product Dermacyd Teen Care Tangerina Mix.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started May 2008
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2008
CompletedFirst Submitted
Initial submission to the registry
September 29, 2008
CompletedFirst Posted
Study publicly available on registry
September 30, 2008
CompletedMay 29, 2009
May 1, 2009
Same day
September 29, 2008
May 28, 2009
Conditions
Outcome Measures
Primary Outcomes (1)
The absence of primary and accumulated dermal irritability will be evaluated using International Contact Dermatitis Research Group (ICDRG) scale.
Throughout the study
Interventions
Eligibility Criteria
You may qualify if:
- Phototype Skin I,II, III e IV
- Integral skin test in the region
You may not qualify if:
- Lactation or gestation
- Use of Anti-inflammatory and/or immuno-Supression drugs 1 month before the study
- Personal 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Sanofilead
Study Sites (1)
Sanofi-Aventis Administrative Office
São Paulo, Brazil
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Jaderson Lima
Sanofi
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
September 29, 2008
First Posted
September 30, 2008
Study Start
May 1, 2008
Primary Completion
May 1, 2008
Study Completion
May 1, 2008
Last Updated
May 29, 2009
Record last verified: 2009-05