Dermacyd PH_DETINLYN Tangerine Mix (Lactic Acid) - Safety.

This study has been completed.
Sponsor:
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00785642
First received: November 4, 2008
Last updated: March 5, 2009
Last verified: March 2009
  Purpose

To prove the safety of the gynaecological formulation in normal conditions of use.


Condition Intervention Phase
Hygiene
Drug: Dermacyd PH_DETINLYN Tangerine Mix (Lactic Acid)
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Safety Dermatological Evaluation: Genital Mucous Irritation - Product Tested: Dermacyd PH_DETINLYN Tangerine Mix (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 the treatment start to the end of the study ] [ Designated as safety issue: No ]

Enrollment: 30
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 Tangerine Mix (Lactic Acid)
Drug: Dermacyd PH_DETINLYN Tangerine Mix (Lactic Acid)

  Eligibility

Ages Eligible for Study:   10 Years to 20 Years
Genders 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;
  • Willingness in following the study procedures and to be present in the clinic at the days and scheduled time;

Exclusion criteria:

  • Lactation or gestational risk or gestation;
  • Use of Anti-inflammatory, immunosuppression or antihistaminic 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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00785642

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

No publications provided

Responsible Party: Medical Affairs Study Director, sanofi-aventis
ClinicalTrials.gov Identifier: NCT00785642     History of Changes
Other Study ID Numbers: LACAC_L_04304
Study First Received: November 4, 2008
Last Updated: March 5, 2009
Health Authority: Brazil: National Health Surveillance Agency

ClinicalTrials.gov processed this record on October 20, 2014