CClinicalTrials.gg
CompletedNCT00107822Updated Oct 6, 2005

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

A Phase 3 interventional study of S-Caine™ Peel (lidocaine and tetracaine cream 7%/7%) in Pain, sponsored by ZARS Pharma Inc.. Completed at 3 sites in United States. Open to participants aged 0 Years to 17 Years. Per ClinicalTrials.gov, last updated 2005-10-06.

Sponsored by ZARS Pharma Inc. · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
80
Allocation
Non-randomized
Ages
0 Years to 17 Years
Sex
All
01

Study 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.

Read the 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 biopsies, shave excisions, deep excisions, electro-surgical procedures, intralesional injections, and laser surgery are frequently performed by dermatologists on a daily basis. Some pain accompanies almost all of these procedures, and a local anesthetic is commonly used. Traditionally, intracutaneous injection of lidocaine (with or without epinephrine) has been the anesthetic of choice. However, patients undergoing these procedures are often afraid of needles and syringes and the pain associated with injections. As a result, topical anesthetic agents have been explored and developed as painless alternatives to injected anesthesia.

S-Caine™ Peel (lidocaine 7% and tetracaine 7% cream) consists of a new eutectic formulation of lidocaine and tetracaine. S-Caine Peel is a topical local anesthetic cream that forms a pliable peel on the skin when exposed to air. S-Caine Peel is not occluded during application.

The pain associated with medical procedures is often under-treated in children. Children often undergo painful procedures with little or no anesthetic, even when effective therapy is available. Reasons for not providing available therapy in children include concerns over adverse side effects, as well as the length of time necessary to provide adequate anesthesia. Recent guidelines strongly advocate for the proactive treatment of pain in children, including the pain associated with medical procedures.

02

Conditions studied

  • Pain

Keywords

  • Pain
03

In context

Lead sponsor

ZARS Pharma Inc. is the lead sponsor of 24 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
0 Years to 17 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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 criteria

Exclusion Criteria:

  • 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.
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
80 participants

Interventions

  • DrugS-Caine™ Peel (lidocaine and tetracaine cream 7%/7%)
06

What researchers measure

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

07

Study locations

3 sites
  • International Dermatology Research, Inc.
    Miami, Florida 33174, United States
  • Jacobi Medical Center
    Bronx, New York 10461, United States
  • Tennessee Clinical Research Center
    Nashville, Tennessee 37215, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 6, 2005, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00107822
Lead sponsor
ZARS Pharma Inc.
First posted
Apr 11, 2005
Start date
Apr 2005
Completion
May 2005
Last update
Oct 6, 2005
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Oct 2005. You cannot join it, but the record below documents what was studied.

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