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

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 adults. This study will also evaluate how well the S-Caine™ Peel eases the pain of the procedure.

Key facts

Study ID

NCT00107835

Run by

ZARS Pharma Inc.

People needed

408

Starts

2005-05-01

Expected to finish

2005-09-01

Last updated by the study team

2012-06-06

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patient is 18 years of age or older.
• Patient elects to undergo a minor or major dermal procedure.
• Patient is able to read and understand a written informed consent and has signed and dated a written informed consent.

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

Where it is running

• International Dermatology Research Inc. — Miami, Florida, United States
• Midwest Cutaneous Research — Clinton Township, Michigan, United States
• Laser and Skin Surgery Center of New York — New York, New York, United States
• Tennessee Clinical Research Center — Nashville, Tennessee, United States
• Texas Dermatology Research Institute — Dallas, Texas, United States

Full record on ClinicalTrials.gov

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