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Dermacyd PH_DETINLYN Sweet Flower (Lactic Acid) - Safety

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00785148
First Posted: November 5, 2008
Last Update Posted: March 6, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Sanofi
  Purpose
To prove the safety of the gynaecological formulation in normal conditions of use.

Condition Intervention Phase
Hygiene Drug: Dermacyd PH_DETINLYN Sweet Flower (Lactic Acid) Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Safety Dermatological Evaluation: Genital Mucous Irritation - Product Tested: Dermacyd PH_DETINLYN Sweet Flower (Lactic Acid).

Resource links provided by NLM:


Further study details as provided by Sanofi:

Primary Outcome Measures:
  • The absence of irritation and the good acceptability will be evaluated using one specific scale which describes the intensity of the reaction. [ Time Frame: From treatment start to the end of study ]

Enrollment: 31
Study Start Date: August 2008
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Dermacyd PH_DETINLYN Sweet Flower (Lactic Acid)
Drug: Dermacyd PH_DETINLYN Sweet Flower (Lactic Acid)

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   10 Years to 20 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Integral skin test in the region,
  • Use of cosmetic product of the same category

Exclusion Criteria:

  • Lactation or gestational risk or gestation
  • Use of Anti-inflammatory, immunosuppression or anti-histaminic drugs
  • Atopic antecedent or allergic to cosmetic product
  • Active cutaneous disease in the evaluation area
  • Diseases which cause immunology decrease, such as diabetes and HIV
  • Endocrinal pathologies
  • Intense solar exposure 15 days before the evaluation
  • Treatment until four months before the selection

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

  Contacts and Locations
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): NCT00785148


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

Responsible Party: Medical Affairs Study Director, sanofi-aventis
ClinicalTrials.gov Identifier: NCT00785148     History of Changes
Other Study ID Numbers: LACAC_L_04298
First Submitted: November 4, 2008
First Posted: November 5, 2008
Last Update Posted: March 6, 2009
Last Verified: March 2009