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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00933946
Other study ID # LACAC_L_04842
Secondary ID
Status Completed
Phase Phase 3
First received July 3, 2009
Last updated September 13, 2010
Start date June 2009
Est. completion date July 2009

Study information

Verified date September 2010
Source Sanofi
Contact n/a
Is FDA regulated No
Health authority Brazil: National Health Surveillance Agency
Study type Interventional

Clinical Trial Summary

Primary Objective:

To demonstrate the absence of irritation potential (primary dermic irritability and cumulated dermic irritability) and allergy (sensibilization) of the product Dermacyd Silver Frutal.


Recruitment information / eligibility

Status Completed
Enrollment 55
Est. completion date July 2009
Est. primary completion date July 2009
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 60 Years
Eligibility Inclusion criteria:

- 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 pregnancy

- Use of Antiinflammatory 30 days and/or immunossupression drugs for until 3 months before volunteers selection

- Diseases which can cause immunosuppresion, such as diabetes, HIV

- Personal history of atopy

- History of sensitivity or irritation for topic products

- Cutaneous active disease (local and/or general) which can modify the study results

- Use of new drugs and/or cosmetics during the study

- Cutaneous reaction

- Previous participation in studies using the same product in test

- Volunteer which has immunodeficiency congenital or acquired

- Relevant history or confirmation of alcohol or other drugs abuse

- Intolerance detected or suspected for some component of the sample tested

- Medecin or sponsor employees or their close family.

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: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
LACTIC ACID(ND)
Dermacyd Silver Frutal (Lactic Acid) sample will be applied like a curative for 21 consecutive days.

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 Evaluation of the absence of primary and accumulated dermical irritability and dermical sensitivity by using International Contact Dermatitis Research Group (ICDRG) scale. from the treatment start to the end of the study (treatment period 6 weeks) No
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