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Sponsored by: |
Sanofi-Aventis |
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Information provided by: | Sanofi-Aventis |
ClinicalTrials.gov Identifier: | NCT00729599 |
To prove the safety, in normal conditions, of the Cepacol Teen, a formulation to odontological usage.
Condition | Intervention | Phase |
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Healthy |
Drug: Cetylpyridinium chloride |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Single Group Assignment, Safety Study |
Official Title: | Monocentric Study, Phase III, for Safety Dermatological Evaluation: Basic Acceptability With Odontological Follow up - Cepacol Teen. |
Enrollment: | 31 |
Study Start Date: | July 2008 |
Primary Completion Date: | August 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
Cetylpyridinium chloride during 21 consecutive days.
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Drug: Cetylpyridinium chloride
Cetylpyridinium chloride during 21 consecutive days.
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Ages Eligible for Study: | 10 Years to 60 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | Sanofi-aventis ( Medical Affairs Study Director ) |
Study ID Numbers: | CPYRY_L_04020 |
Study First Received: | August 4, 2008 |
Last Updated: | August 6, 2008 |
ClinicalTrials.gov Identifier: | NCT00729599 |
Health Authority: | Brazil: National Health Surveillance Agency |
Benzocaine Cetylpyridinium Healthy |
Anti-Infective Agents Anti-Infective Agents, Local Therapeutic Uses Pharmacologic Actions |