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

NCT00107835 | Completed Phase 3

• 1 other identifier: SCP-45-05
• Study Type: interventional
• Target: 408
• Locations: 1 country
• Sites: 5

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 also evaluate how well the S-Caine™ Peel eases the pain of the procedure.

Conditions

Pain

Keywords

Pain

Outcome Measures

Primary Outcomes (1)

• Number of participants with adverse events

  To evaluate the safety of a single administration of S-Caine Peel in providing dermal anesthesia over intact skin prior to a minor and major dermal procedure in adults

  20-30 minutes

Secondary Outcomes (1)

• Adequacy of Anesthesia

  20-30 minutes

Study Arms (1)

S-Caine Peel

EXPERIMENTAL

Drug: S-Caine™ Peel (lidocaine and tetracaine cream 7%/7%)

Interventions

S-Caine™ Peel (lidocaine and tetracaine cream 7%/7%) DRUG

S-Caine Peel comprising a 1:1 eutectic mixture of 7% lidocaine, and 7% tetracaine was applied topically. The study drug remained on the treatment area for 20-30 minutes for minor dermal procedures and 60 minutes for major dermal procedures

Also known as: Pliaglis

S-Caine Peel

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

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 has enrolled in any previous study involving S-Caine Peel.

Sponsors & Collaborators

• ZARS Pharma Inc.: lead

Study Sites (5)

International Dermatology Research Inc.

Miami, Florida, 33144, United States

Location

Midwest Cutaneous Research

Clinton Township, Michigan, 48038, United States

Location

Laser and Skin Surgery Center of New York

New York, New York, 10016, United States

Location

Tennessee Clinical Research Center

Nashville, Tennessee, 37215, United States

Location

Texas Dermatology Research Institute

Dallas, Texas, 75230, United States

Location

Related Links

• Pain

MeSH Terms

Conditions

Pain

Interventions

Lidocaine

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Alicia Barba, MD

  International Dermatology Research, Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 8, 2005
• First Posted: April 11, 2005
• Study Start: May 1, 2005
• Primary Completion: September 1, 2005
• Study Completion: September 1, 2005
• Last Updated: June 6, 2012

Record last verified: 2012-06

Locations

US (5)