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Dermacyd Femina (Lactic Acid) Pocket BR - Photo Evaluation

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ClinicalTrials.gov Identifier: NCT00783640
Recruitment Status : Completed
First Posted : November 3, 2008
Last Update Posted : December 19, 2008
Sponsor:
Information provided by:
Sanofi

Study Description
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Brief Summary:
To demonstrate the absence of photoirritation and photosensitization potential of the product Dermacyd Femina (Lactic Acid) Pocket BR.

Condition or disease Intervention/treatment Phase
Hygiene Drug: Lactic Acid Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 27 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Dermatological Evaluation of the Photo Irritation and Photo Sensitivity Potential for Dermacyd Femina Pocket BR.
Study Start Date : October 2008
Actual Primary Completion Date : November 2008

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U.S. FDA Resources

Arms and Interventions
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Arm Intervention/treatment
Experimental: 1
Lactic Acid
 Drug: Lactic Acid
Drug: Lactic Acid (Dermacyd Femina)


Outcome Measures
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Primary Outcome Measures :
  1. 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 ]
  2. The sensibility will be evaluated according to the skin type. [ Time Frame: Throughout the study ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes 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
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00783640


Locations
Brazil
Sanofi-Aventis Administrative Office
Sao Paulo, Brazil
Sponsors and Collaborators
Sanofi
Investigators
Study Director: Jaderson Lima Sanofi
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Additional Information:
Related Info  This link exits the ClinicalTrials.gov site

Responsible Party: Medical Affairs Study Director, sanofi-aventis
ClinicalTrials.gov Identifier: NCT00783640     History of Changes
Other Study ID Numbers: LACAC_L_04371
First Posted: November 3, 2008    Key Record Dates
Last Update Posted: December 19, 2008
Last Verified: December 2008