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

Completed · Phase 3

Conditions studied: Pain

In brief

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.

Key facts

Study ID: NCT00107822
Run by: ZARS Pharma Inc.
People needed: 80
Starts: 2005-04-01
Expected to finish: 2005-05-01
Last updated by the study team: 2005-10-06

Who can join

Age: any, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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.

You may not qualify if…

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.

Where it is running

International Dermatology Research, Inc. — Miami, Florida, United States
Jacobi Medical Center — The Bronx, New York, United States
Tennessee Clinical Research Center — Nashville, Tennessee, United States

Full record on ClinicalTrials.gov

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