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Dermacyd Breeze Pocket BR (Lactic Acid) - Acceptability

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ClinicalTrials.gov Identifier: NCT00793026
Recruitment Status : Completed
First Posted : November 18, 2008
Last Update Posted : December 19, 2008
Sponsor:
Information provided by:
Sanofi

Brief Summary:
The purpose of this study is to prove the safety of the gynaecological formulation in normal conditions of use.

Condition or disease Intervention/treatment Phase
Hygiene Drug: Dermacyd Breeze Pocket BR (Lactic Acid) Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Safety Dermatological Evaluation: Genital Mucous Irritation - Test in Use - Dermacyd Breeze Pocket BR (Lactic Acid).
Study Start Date : November 2008
Actual Primary Completion Date : November 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: 1
Dermacyd Breeze Pocket BR (Lactic Acid)
Drug: Dermacyd Breeze Pocket BR (Lactic Acid)
Dermacyd Breeze Pocket BR (Lactic Acid) during 21 consecutive days



Primary Outcome Measures :
  1. Absence of irritation [ Time Frame: Throughout the study ]
  2. Good acceptability [ Time Frame: Throughout the study ]


Information from the National Library of Medicine

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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:

  • Integral skin test in the region;
  • To use products of the same category;

Exclusion criteria:

  • Lactation or gestation;
  • Use of anti-inflammatory, anti-histaminic or immunosuppressant drugs;
  • Cutaneous disease (local or spread) in the evaluation area;
  • Pathology which may cause immunity depression, such as HIV, diabetes;
  • Endocrine pathology
  • Solar exposure 15 days before evaluation;
  • Treatment until four months before the selection.
  • Allergic or atopic history to cosmetics products

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): NCT00793026


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: NCT00793026     History of Changes
Other Study ID Numbers: LACAC_L_04365
First Posted: November 18, 2008    Key Record Dates
Last Update Posted: December 19, 2008
Last Verified: December 2008