Safety Study of S-Caine Peel (Skin Numbing Cream) Before a Painful Dermatologic Procedure in Children
An Open-Label Safety Study to Evaluate the Use of S-Caine™ Peel (Lidocaine 7% and Tetracaine 7% Cream) in Pediatric Patients Undergoing a Minor or Major Dermal Procedure
1 other identifier
interventional
80
1 country
3
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 also evaluate how well the S-Caine™ Peel eases the pain of the procedure.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3 pain
Started Apr 2005
Shorter than P25 for phase_3 pain
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2005
CompletedFirst Submitted
Initial submission to the registry
April 8, 2005
CompletedFirst Posted
Study publicly available on registry
April 11, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2005
CompletedOctober 6, 2005
October 1, 2005
April 8, 2005
October 5, 2005
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
To evaluate the safety of a single administration of S-Caine Peel in providing dermal anesthesia over intact skin before a minor and major dermal procedure in pediatric patients
Secondary Outcomes (1)
To evaluate the adequacy of anesthesia provided for minor and major dermal procedures
Interventions
Eligibility Criteria
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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- ZARS Pharma Inc.lead
Study Sites (3)
International Dermatology Research, Inc.
Miami, Florida, 33174, United States
Jacobi Medical Center
The Bronx, New York, 10461, United States
Tennessee Clinical Research Center
Nashville, Tennessee, 37215, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
April 8, 2005
First Posted
April 11, 2005
Study Start
April 1, 2005
Study Completion
May 1, 2005
Last Updated
October 6, 2005
Record last verified: 2005-10