Dermacyd Femina (Lactic Acid) Pocket BR - Compatibility

Hygiene Clinical Trial

Official title:

Study for Dermatological Evaluation of Topic Compatibility (Primary and Accumulated Dermical Irritability, Dermical Sensitivity) of Dermacyd Femina Pocket BR.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00783861
• Other study ID #: LACAC_L_04370
• 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 Femina (Lactic Acid) Pocket BR.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 54
• 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;

• 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.

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

• Hygiene

Intervention

Drug:
• Lactic Acid
Lactic Acid (Dermacyd Femina)

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

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