Status:
COMPLETED
Safety Study of S-Caine Peel (Skin Numbing Cream) Before a Painful Dermatologic Procedure in Adults
Lead Sponsor:
ZARS Pharma Inc.
Conditions:
Pain
Eligibility:
All Genders
18+ 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 adults. This study will al...
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 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.
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 has enrolled in any previous study involving S-Caine Peel.
Key Trial Info
Start Date :
May 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2005
Estimated Enrollment :
408 Patients enrolled
Trial Details
Trial ID
NCT00107835
Start Date
May 1 2005
End Date
September 1 2005
Last Update
June 6 2012
Active Locations (5)
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1
International Dermatology Research Inc.
Miami, Florida, United States, 33144
2
Midwest Cutaneous Research
Clinton Township, Michigan, United States, 48038
3
Laser and Skin Surgery Center of New York
New York, New York, United States, 10016
4
Tennessee Clinical Research Center
Nashville, Tennessee, United States, 37215