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

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

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00729599
Acronym
Cepacol Teen
Enrollment
31
Registered
2008-08-07
Start date
2008-07-31
Completion date
Unknown
Last updated
2009-03-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hygiene

Brief summary

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

Interventions

Cetylpyridinium chloride during 21 consecutive days.

Sponsors

Sanofi
Lead SponsorINDUSTRY

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
10 Years to 60 Years
Healthy volunteers
Yes

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;

Design outcomes

Primary

MeasureTime frame
Patients will be evaluated according to the adverse reactions and the intensity of them.21 days

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026