NCT00668577CompletedPhase 3
Study for Dermatological Evaluation of Topic Compatibility (Primary and Accumulated Dermical Irritability, Dermical Sensitivity) of Dermacyd Breeze.
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Sanofi
- Enrollment
- 52
- Locations
- 1
- Primary Endpoint
- The absence of primary and accumulated dermal irritability and dermal sensitivity will be evaluated using International Contact Dermatitis Research Group (ICDRG) scale.
Study Overview
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 Pocket BR.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 60 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Phototype Skin I,II, III e IV
- •Integral skin test in the region
Exclusion Criteria
- •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.
Outcomes
Primary Outcomes
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
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (1)
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