Dermacyd Femina (Lactic Acid) Pocket BR - Photo Evaluation

This study has been completed.
Sponsor:
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00783640
First received: October 31, 2008
Last updated: December 18, 2008
Last verified: December 2008
  Purpose

To demonstrate the absence of photoirritation and photosensitization potential of the product Dermacyd Femina (Lactic Acid) Pocket BR.


Condition Intervention Phase
Hygiene
Drug: Lactic Acid
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Dermatological Evaluation of the Photo Irritation and Photo Sensitivity Potential for Dermacyd Femina Pocket BR.

Resource links provided by NLM:


Further study details as provided by Sanofi:

Primary Outcome Measures:
  • The photo irritation test and the photosensitivity will be measured using UVA irradiation and evaluated according International Contact Dermatitis Research Group (ICDRG) scale. [ Time Frame: Throughout the study ] [ Designated as safety issue: No ]
  • The sensibility will be evaluated according to the skin type. [ Time Frame: Throughout the study ] [ Designated as safety issue: No ]

Enrollment: 27
Study Start Date: October 2008
Primary Completion Date: November 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Lactic Acid
Drug: Lactic Acid
Drug: Lactic Acid (Dermacyd Femina)

  Eligibility

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

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.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00783640

Locations
Brazil
Sanofi-Aventis Administrative Office
Sao Paulo, Brazil
Sponsors and Collaborators
Sanofi
Investigators
Study Director: Jaderson Lima Sanofi
  More Information

Additional Information:
No publications provided

Responsible Party: Medical Affairs Study Director, sanofi-aventis
ClinicalTrials.gov Identifier: NCT00783640     History of Changes
Other Study ID Numbers: LACAC_L_04371
Study First Received: October 31, 2008
Last Updated: December 18, 2008
Health Authority: Brazil: National Health Surveillance Agency

ClinicalTrials.gov processed this record on April 16, 2014