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Dermacyd Breeze Pocket BR (Lactic Acid) - Acceptability

This study has been completed.
Sponsor:
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00793026
First received: November 17, 2008
Last updated: December 18, 2008
Last verified: December 2008

November 17, 2008
December 18, 2008
November 2008
November 2008   (final data collection date for primary outcome measure)
  • Absence of irritation [ Time Frame: Throughout the study ] [ Designated as safety issue: No ]
  • Good acceptability [ Time Frame: Throughout the study ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00793026 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
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Dermacyd Breeze Pocket BR (Lactic Acid) - Acceptability
Safety Dermatological Evaluation: Genital Mucous Irritation - Test in Use - Dermacyd Breeze Pocket BR (Lactic Acid).

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

Not Provided
Interventional
Phase 3
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Hygiene
Drug: Dermacyd Breeze Pocket BR (Lactic Acid)
Dermacyd Breeze Pocket BR (Lactic Acid) during 21 consecutive days
Experimental: 1
Dermacyd Breeze Pocket BR (Lactic Acid)
Intervention: Drug: Dermacyd Breeze Pocket BR (Lactic Acid)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
30
Not Provided
November 2008   (final data collection date for primary outcome measure)

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.

Female
18 Years to 60 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Brazil
 
NCT00793026
LACAC_L_04365
Not Provided
Medical Affairs Study Director, sanofi-aventis
Sanofi
Not Provided
Study Director: Jaderson Lima Sanofi
Sanofi
December 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP