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Dermacyd Breeze (Lactic Acid) Pocket BR - Photo Evaluation

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ClinicalTrials.gov Identifier: NCT00784069
Recruitment Status : Completed
First Posted : November 3, 2008
Last Update Posted : December 19, 2008
Sponsor:
Information provided by:
Sanofi

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

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

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 Breeze Pocket BR.
Study Start Date : October 2008
Actual Primary Completion Date : November 2008

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 1
Lactic Acid (Dermacyd Breeze)
Drug: Lactic Acid
Lactic Acid (Dermacyd Breeze)




Primary Outcome Measures :
  1. To demonstrate the absence of photoirritation and photosensitization potential of the product Dermacyd Breeze Pocket BR. [ Time Frame: Throughout the study ]


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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 II and III;
  • 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 15 days before the selection;
  • Diseases which can cause immunity decrease, such as HIV, diabetes;
  • Use of drug photosensitizer;
  • History of sensitivity or irritation for topic products;
  • Active cutaneous disease which can change the study results;
  • History of photodermatosis active;
  • Family or personal antecedent of cutaneous photoinduced neoplasias;
  • Presence of a precursor lesion of cutaneous neoplasia, such as nevus melanocyte and queratoses actinium;
  • Intense solar exposure in the study area;
  • 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.


Information from the National Library of Medicine

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): NCT00784069


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

Additional Information:
Responsible Party: Medical Affairs Study Director, sanofi-aventis
ClinicalTrials.gov Identifier: NCT00784069     History of Changes
Other Study ID Numbers: LACAC_L_04367
First Posted: November 3, 2008    Key Record Dates
Last Update Posted: December 19, 2008
Last Verified: December 2008