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Acceptability Dermacyd Wipes - Lactoserum - Hygiene

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ClinicalTrials.gov Identifier: NCT00397527
Recruitment Status : Completed
First Posted : November 9, 2006
Last Update Posted : May 16, 2008
Sponsor:
Information provided by:
Sanofi

Brief Summary:
The purpose of this study is to demonstrate the safety of the gynecological formulation in normal and usual usage condition of Dermacyd Wipes

Condition or disease Intervention/treatment Phase
Hygiene Drug: lactoserum Phase 3

Study Type : Interventional  (Clinical Trial)
Enrollment : 30 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Safety Dermatological Evaluation: Acceptability With Gynecological Follow up of Dermacyd Wipes
Study Start Date : July 2006



Primary Outcome Measures :
  1. Adverse events and their association with the treatment.


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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

The following information on clinical trials is provided for information purposes only to allow patients and physicians to have an initial discussion about the trial. This information is not intended to be complete information about the trial, to contain all considerations that may be relevant to potential participation in the trial, or to replace the advice of a personal physician or health professional.

Main criteria are listed hereafter:

Inclusion Criteria:

  • Integral skin in the tested region

Exclusion Criteria:

  • Pregnancy or breastfeeding women;
  • Use of antiinflammatory or immunosuppression drugs;
  • Topical medication use at the region to be treated;
  • Cutaneous disease or active gynaecological disease which may interfer in study results;
  • Personal history of allergic disease at the area to be treated;
  • Allergic or atopic history.

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): NCT00397527


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

ClinicalTrials.gov Identifier: NCT00397527     History of Changes
Other Study ID Numbers: LACTO_L_01810
First Posted: November 9, 2006    Key Record Dates
Last Update Posted: May 16, 2008
Last Verified: May 2008