Safety Study of S-Caine Peel (Skin Numbing Cream) Before a Painful Dermatologic Procedure in Children

• Status: Completed
• Trial end date: 2005-05-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the safety of one treatment of S-Caine™ Peel (skin numbing cream) applied on healthy skin before a painful dermatologic procedure in children. This study will also evaluate how well the S-Caine™ Peel eases the pain of the procedure.

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

Details

• Lead Sponsor: ZARS Pharma Inc.
• Treatments: Lidocaine; Tetracaine

Criteria

Inclusion Criteria:

• Patient is 0 through 17 years of age.

• Patient requires a minor or major dermal procedure.

• Patient's legal guardian is able to read and understand a written informed consent and has signed and dated a written informed consent. The patient must provide assent whenever possible.

Exclusion Criteria:

• Patient has known allergies, contraindications or sensitivities to lidocaine, tetracaine, or other local anesthetics of the amide or ester type or to any components of the test materials.

• Patient has known active atopic dermatitis at the designated treatment site.

• Patient has damaged, denuded or broken skin at the designated treatment site.

• Patient is pregnant or breastfeeding.

• Patient has participated in an investigational study or clinical trial of an unapproved drug within the previous 30 days.

• Patient was born prematurely (less than 38 weeks).

• Patient has enrolled in any previous study involving S-Caine Peel.