NCT00668226CompletedPhase 3
Dermatological Evaluation of the Photo Irritation and Photo Sensitivity Potential for Dermacyd Delicata Pocket BR.
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Sanofi
- Enrollment
- 25
- Locations
- 1
- Primary Endpoint
- The photo irritation test and the photosensitivity will be measured using UVA irradiation and evaluated according International Contact Dermatitis Research Group (ICDRG) scale. The sensibility will be evaluated according to the skin type.
Study Overview
Brief Summary
The purpose of this study is to prove the absence of photo irritation and photo sensitivity potential of the product Dermacyd Delicata 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 II and III
- •Integral skin test in the region
Exclusion Criteria
- •Lactation or gestation;
- •Use of Antiinflammatory and/or immunosuppression drugs 15 days before the selection
- •Diseases which can cause immunity decrease, such as HIV, diabetes
- •Use of drug photosensitizer
- •History of sensitivity or irritation for topic products
- •Active cutaneous disease which can change the study results
- •History or photodermatosis active
- •Family or personal antecedent of cutaneous photoinduced neoplasias
- •Presence of a precursor lesion of cutaneous neoplasia, such as nevus melanocyte and keratoses actinium
- •Intense solar exposure in the study area
- •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 photo irritation test and the photosensitivity will be measured using UVA irradiation and evaluated according International Contact Dermatitis Research Group (ICDRG) scale. The sensibility will be evaluated according to the skin type.
Time Frame: 5 weeks
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (1)
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