Dermatological Evaluation of Topic Compatibility-Dermacyd Tina Gel Sweet Flower

Hygiene Clinical Trial

Official title:

Study for Dermatological Evaluation of Topic Compatibility (Primary and Accumulated Dermical Irritability, Dermical Sensitivity) of Dermacyd Tina Gel Sweet Flower.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00668668
• Other study ID #: LACAC_L_03733
• Status: Completed
• Phase: Phase 3
• First received: April 23, 2008
• Last updated: January 27, 2009
• Start date: December 2007

Study information

• Verified date: January 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 dermic irritability and cumulated dermic irritability) and allergy (sensibilization) of the product Dermacyd Tina Gel Sweet Flower.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. primary completion date: January 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 Antiinflammatory and/or immunosuppression drugs

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

Related Conditions & MeSH terms

• Hygiene

Intervention

Drug:
• Lactic acid (Dermacid)

Locations

Country	Name	City	State
Brazil	Sanofi-aventis	São 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 and dermal sensitivity will be evaluated using International Contact Dermatitis Research Group (ICDRG) scale.		six weeks	Yes