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Topic Compatibility Dermacyd Delicata - New Fragrance - Lactoserum - Hygiene

This study has been completed.
Sponsor:
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00380991
First received: September 25, 2006
Last updated: May 15, 2008
Last verified: May 2008
History of Changes
  Purpose

The purpose of this study is to demonstrate the absence of potential irritation (primary dermic irritability and cumulated dermic irritability) and allergy (sensibilization) of the product Dermacyd Delicata (new fragrance of Dermacyd)


Condition Intervention Phase
Hygiene
 Drug: lactoserum
 Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Dermatological Evaluation of Topic Compatibility (Primary and Accumulated Dermical Irritability and Dermical Sensitivity) of Dermacyd Delicata (New Fragrance)

Further study details as provided by Sanofi:

Primary Outcome Measures:
  • score evaluation of the cutaneous reaction, preconized by International Contact Dermatitis Research Group (ICDRG)

Estimated Enrollment: 50
Study Start Date: May 2006
  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Phototype Skin I,II, III and IV
  • Integral skin test in the region;

Exclusion Criteria:

  • Lactation or gestation
  • Use of Antiinflammatory and/or immunosuppression drugs
  • Personal history of atopy;
  • History of sensibilization or irritation for topic products;
  • Active cutaneous disease;
  • Use of new drugs or cosmetics during the study
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00380991

Locations
Brazil
Sanofi-aventis
São Paulo, Brazil
Sponsors and Collaborators
Sanofi
Investigators
Study Director: Jaderson Lima Sanofi
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00380991     History of Changes
Other Study ID Numbers: LACTO_L_01840
Study First Received: September 25, 2006
Last Updated: May 15, 2008
Health Authority: Brazil: National Health Surveillance Agency

ClinicalTrials.gov processed this record on May 19, 2013