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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00784121
Other study ID # LACAC_L_04366
Secondary ID
Status Completed
Phase Phase 3
First received October 31, 2008
Last updated December 18, 2008
Start date October 2008

Study information

Verified date December 2008
Source Sanofi
Contact n/a
Is FDA regulated No
Health authority Brazil: National Health Surveillance Agency
Study type Interventional

Clinical Trial Summary

To demonstrate the absence of irritation potential (primary dermic irritability and cumulated dermic irritability) and allergy (sensibilization) of the product Dermacyd Breeze (Lactic Acid) Pocket BR.


Recruitment information / eligibility

Status Completed
Enrollment 54
Est. completion date
Est. primary completion date November 2008
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 60 Years
Eligibility Inclusion criteria:

- Age between 18 and 60 years old;

- Phototype Skin I,II, III e IV

- Integral skin test in the region;

- Willingness in following the study procedures and to be present in the clinic at the days and scheduled time for medical evaluations and for application of occlusion;

Exclusion criteria:

- Lactation or gestation

- Use of Antiinflammatory and/or immunosuppression drugs one 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/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 Breeze)

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 dermical irritability and dermical sensitivity will be evaluated using International Contact Dermatitis Research Group (ICDRG) scale. Throughout the study No
See also
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Completed NCT00783640 - Dermacyd Femina (Lactic Acid) Pocket BR - Photo Evaluation Phase 3
Completed NCT00784069 - Dermacyd Breeze (Lactic Acid) Pocket BR - Photo Evaluation Phase 3
Completed NCT00783861 - Dermacyd Femina (Lactic Acid) Pocket BR - Compatibility Phase 3
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