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Safety Dermatological Evaluation: Acceptability With Odontological Follow up - Cepacol Teen. (Cepacol Teen)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00729599
First Posted: August 7, 2008
Last Update Posted: March 4, 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, in normal conditions, of the Cepacol Teen, a formulation to odontological usage.

Condition Intervention Phase
Hygiene Drug: Cetylpyridinium chloride Phase 3

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Single Site Study, Phase III, for Safety Dermatological Evaluation: Basic Acceptability With Odontological Follow up - Cepacol Teen.

Resource links provided by NLM:


Further study details as provided by Sanofi:

Primary Outcome Measures:
  • Patients will be evaluated according to the adverse reactions and the intensity of them. [ Time Frame: 21 days ]

Enrollment: 31
Study Start Date: July 2008
Primary Completion Date: August 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Cetylpyridinium chloride during 21 consecutive days.
Drug: Cetylpyridinium chloride
Cetylpyridinium chloride during 21 consecutive days.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   10 Years to 60 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Integral buccal mucous (without oral pathologies);
  • Normal odontological exams;

Exclusion Criteria:

  • Lactation or gestational risk or gestation;
  • Use of Antiinflammatory or immunosuppression drugs 15 days before the study;
  • Being in odontological treatment;
  • Pathological or mucous disease which can interfere or active gynaecological disease which may interfere wtih study results;
  • Personal history of allergic disease in the area to be treated;
  • Allergic or atopic history;
  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): NCT00729599


Locations
Brazil
Sanofi-aventis
São Paulo, Brazil
Sponsors and Collaborators
Sanofi
Investigators
Study Director: Jaderson Lima, MD Sanofi-aventis administrative office Brazil
  More Information

Responsible Party: Medical Affairs Study Director, Sanofi-aventis
ClinicalTrials.gov Identifier: NCT00729599     History of Changes
Other Study ID Numbers: CPYRY_L_04020
First Submitted: August 4, 2008
First Posted: August 7, 2008
Last Update Posted: March 4, 2009
Last Verified: March 2009

Additional relevant MeSH terms:
Dermatologic Agents
Cetylpyridinium
Anti-Infective Agents, Local
Anti-Infective Agents