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

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

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Key information

Conditions

Hygiene

Age range

10 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Sanofi-aventis

São Paulo, Brazil

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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;

Treatment and study plan

cetylpyridinium chloride

Drug

Cetylpyridinium chloride during 21 consecutive days.

Primary outcomes

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

Time frame: 21 days

Sponsors and collaborators

Lead sponsor

Sanofi

Industry

Registry information

Official study title

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

Acronym: Cepacol Teen

Important dates

Study start: 2008
Primary completion: 2008
First posted: Aug 7, 2008
Registry last updated: Mar 4, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed