Status:
COMPLETED
Safety Study of S-Caine Peel (Skin Numbing Cream) Before a Painful Dermatologic Procedure in Children
Lead Sponsor:
ZARS Pharma Inc.
Conditions:
Pain
Eligibility:
All Genders
Up to 17 years
Phase:
PHASE3
Brief 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 ...
Detailed Description
The practice of dermatology is seeing a rise in the number of surgical and laser procedures as technological advances have expanded the number of conditions amenable to these evolving therapies. Skin ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 1 2005
Trial Type :
INTERVENTIONAL
End Date :
May 1 2005
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT00107822
Start Date
April 1 2005
End Date
May 1 2005
Last Update
October 6 2005
Active Locations (3)
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1
International Dermatology Research, Inc.
Miami, Florida, United States, 33174
2
Jacobi Medical Center
The Bronx, New York, United States, 10461
3
Tennessee Clinical Research Center
Nashville, Tennessee, United States, 37215