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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00783939
Other study ID # LACAC_L_04307
Secondary ID
Status Completed
Phase Phase 3
First received October 31, 2008
Last updated March 5, 2009
Start date September 2008

Study information

Verified date March 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 prove the safety in normal conditions of useof the product Dermacyd PH_DETINBACK Tangerine Mix (Lactic Acid).


Recruitment information / eligibility

Status Completed
Enrollment 31
Est. completion date
Est. primary completion date September 2008
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 10 Years to 20 Years
Eligibility Inclusion criteria:

- Age between 10 and 20 years old;

- Integral skin test in the region;

- Use of cosmetic product of the same category;

- Willingness in following the study procedures and to be present in the clinic at the days and scheduled time;

Exclusion criteria:

- Lactation or gestational risk or gestation;

- Use of Anti-inflammatory, immunosuppression or antihistaminic drugs;

- Atopic antecedent or allergic to cosmetic product;

- Active cutaneous disease in the evaluation area;

- Diseases which cause immunology decrease, such as diabetes and HIV;

- Endocrinal pathologies;

- Intense solar exposure 15 days before the evaluation;

- Treatment until four months before the selection;

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/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care


Related Conditions & MeSH terms


Intervention

Drug:
Lactic Acid
Lactic Acid (Dermacyd PH_DETINBACK Tangerine Mix)

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 irritation and the good acceptability will be evaluated using one specific scale which describes the intensity of the reaction. From the treatment start to the end of the study No
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