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

Information source: Sanofi
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Hygiene

Intervention: Cetylpyridinium chloride (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Sanofi

Official(s) and/or principal investigator(s):
Jaderson Lima, MD, Study Director, Affiliation: Sanofi-aventis administrative office Brazil

Summary

To prove the safety, in normal conditions, of the Cepacol Teen, a formulation to odontological usage.

Clinical Details

Official title: Single Site Study, Phase III, for Safety Dermatological Evaluation: Basic Acceptability With Odontological Follow up - Cepacol Teen.

Study design: Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Patients will be evaluated according to the adverse reactions and the intensity of them.

Eligibility

Minimum age: 10 Years. Maximum age: 60 Years. Gender(s): Both.

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;

Locations and Contacts

Sanofi-aventis, São Paulo, Brazil
Additional Information

Starting date: July 2008
Last updated: March 3, 2009

Page last updated: August 23, 2015

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