Study of a New Medical Device in Gel Formulation Versus Calgel® for the Topical Treatment of Teething in Infants

• Status: Completed
• Trial end date: 2013-12-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a randomized, open label, parallel-groups, multicenter study. The study will be conducted in three clinical sites. Test Medical Device: 0.54% Hyaluronic Acid rose honey flavour gel medical device class IIa.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ricerfarma S.r.l
• Collaborators: Latis S.r.l.; Opera Contract Research Organization SRL; Opera CRO, a TIGERMED Group Company
• Treatments: Cetylpyridinium; Hyaluronic Acid; Lidocaine

Criteria

Inclusion Criteria:

1. Male or female infants aged between 6 and 36 months.

2. Teething diagnosed by the presence of at least 3 of the following clinical symptoms:

pain, swelling, gingival rush, hyper-salivation, redness, abnormal teeth depth.

3. At the moment of inclusion no subcutaneous mucosal laceration must be yet appeared.

4. Informed consent form signed by parents or legal representative.

5. Infants and parents who are in a general position to follow all study requirements

Exclusion Criteria:

1. Infants in hospitalization and/or immobilization and/or confinement to bed.

2. Infants with known history of severe renal insufficiency and/or known history of severe cardiac dysfunction and/or liver problems

3. Use of topical Lidocaine and/or topical Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) within one day before inclusion.

4. Use of systemic NSAIDs within 3 days before inclusion and/or use of systemic anesthetics within 10 days before.

5. Concomitant use during the period of study of NSAIDs and/or any anesthetics (obviously Calgel® is allowed in patients randomized in group B, only)

6. Subjects with known history of allergic or adverse reactions to avian proteins or to HA and to any ingredient of the Medical Device and/or of the comparator on study.

7. Infants whose parents suffer from any form of psychiatric disorder or other condition which, in the opinion of the Investigator, might invalidate the required prescription and/or observation or complicate communication with the subject.

8. Infants simultaneously participating or having participated in the last month before Visit 1 in another clinical trial.

9. Infants already treated under this protocol.