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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00761800
Other study ID # LACAC_L_04087
Secondary ID
Status Completed
Phase Phase 3
First received September 29, 2008
Last updated May 28, 2009
Start date May 2008
Est. completion date May 2008

Study information

Verified date May 2009
Source Sanofi
Contact n/a
Is FDA regulated No
Health authority Brazil: National Health Surveillance Agency
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 51
Est. completion date May 2008
Est. primary completion date May 2008
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 60 Years
Eligibility Inclusion Criteria:

- Phototype Skin I,II, III e IV

- Integral skin test in the region

Exclusion Criteria:

- 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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care


Related Conditions & MeSH terms


Intervention

Drug:
Lactic acid


Locations

Country Name City State
Brazil Sanofi-Aventis Administrative Office Sao Paulo

Sponsors (1)

Lead Sponsor Collaborator
Sanofi

Country where clinical trial is conducted

Brazil, 

Outcome

Type Measure Description Time frame Safety issue
Primary The absence of primary and accumulated dermal irritability will be evaluated using International Contact Dermatitis Research Group (ICDRG) scale. Throughout the study No
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