S-Caine™ Peel (Skin Numbing Cream) to Treat Pain During Pulsed Dye Laser (PDL) Therapy in Adults
A Randomized, Double-Blind, Placebo Controlled, Parallel Study Evaluating the Efficacy of S-Caine™ Peel (Lidocaine 7% and Tetracaine 7% Cream) to Provide Local Dermal Anesthesia for Pulsed Dye Laser Therapy in Adults
1 other identifier
interventional
80
1 country
3
Brief Summary
Pulsed dye laser (PDL) on the face is painful. For this reason, local anesthesia is commonly used to eliminate or minimize the pain. S-Caine™ Peel (lidocaine 7% and tetracaine 7% cream) is a eutectic formulation of lidocaine and tetracaine. The purpose of this study is to evaluate the efficacy of S-Caine Peel for induction of local dermal anesthesia for PDL therapy in adults.
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 Jun 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
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 12, 2005
CompletedFirst Posted
Study publicly available on registry
May 13, 2005
CompletedStudy Start
First participant enrolled
June 1, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2005
CompletedJune 5, 2012
June 1, 2012
4 months
May 12, 2005
June 4, 2012
Conditions
Outcome Measures
Primary Outcomes (1)
Pain Intensity
Patient's evaluation of procedural pain intensity using the 100 mm Visual Analog Scale (VAS).
20 minutes
Secondary Outcomes (1)
Number of participants with adverse events
20 minutes
Study Arms (2)
S-Caine Peel
EXPERIMENTALPlacebo Peel
PLACEBO COMPARATORInterventions
S-Caine Peel, composed of a 1:1 (w:w) eutectic mixture of 7% lidocaine and 7% tetracaine, applied topically. S-Caine Peel applied at approximately 1 mm in thickness and remained on the treatment area for 20 minutes (±2 minutes).
Placebo Peel applied topically at approximately 1 mm in thickness and remained on the treatment area for 20 minutes (±2 minutes).
Eligibility Criteria
You may qualify if:
- Patient is 18 years of age or older
- Patient elects to undergo PDL therapy for the treatment of vascular lesions on the face
You may not qualify if:
- Patient is pregnant or breastfeeding
- Patient has participated in a clinical trial of an unapproved drug within the previous 30 days
- Patient has participated in any clinical trial involving S-Caine Peel
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- ZARS Pharma Inc.lead
Study Sites (3)
Washington Institute of Dermatologic Laser Surgery
Washington D.C., District of Columbia, 20037, United States
Midwest Cutaneous Research
Clinton Township, Michigan, 48038, United States
Laser and Skin Surgery Center of New York
New York, New York, 10016, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Tina Alster, MD
Washington Institute of Dermatologic Laser Surgery
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 12, 2005
First Posted
May 13, 2005
Study Start
June 1, 2005
Primary Completion
October 1, 2005
Study Completion
October 1, 2005
Last Updated
June 5, 2012
Record last verified: 2012-06