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

Sanofi

Status and phase: Completed; Phase 3

Conditions: Hygiene

Treatments: Drug: Cetylpyridinium chloride

Study type: Interventional

Funder types: Industry

Identifiers

NCT00729599

CPYRY_L_04020

Details and patient eligibility

About

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

Enrollment: 31 patients

Sex: All

Ages: 10 to 60 years old

Volunteers: Accepts Healthy Volunteers

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;

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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31 participants in 1 patient group

1

Experimental group

Description:

Cetylpyridinium chloride during 21 consecutive days.

Treatment:

Drug: Cetylpyridinium chloride