S-Caine™ Peel (Skin Numbing Cream) to Treat Pain During Pulsed Dye Laser (PDL) Therapy in Adults

Sponsor

ZARS Pharma Inc. (Industry)

Overall Status

Completed

CT.gov ID

NCT00110773

Collaborator

(none)

Enrollment

Locations

Arms

Duration (Months)

26.7

Patients Per Site

6.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pain	Drug: S-Caine™ Peel (lidocaine and tetracaine topical cream 7%/7%) Drug: Placebo Peel	Phase 3

Detailed Description

This was a multi-center (5 centers), double-blind, placebo-controlled, parallel study that included 80 adults who met all the eligibility criteria and who were undergoing PDL therapy for the treatment of vascular lesions on the face.

During the screening visit, the study, including potential risks and benefits, was clearly explained to each patient, and written informed consent was obtained from each patient. The screening visit also included: evaluating eligibility criteria, obtaining a medical history (including skin type, demographic data, and concomitant medications), a brief physical examination, and a urine pregnancy test (for women of childbearing potential). The screening visit could be completed on the same day as the procedure visit.

At the procedure visit, eligible patients were assigned the next available sequential patient number. By having a patient number assigned to them, patients were randomized to receive S-Caine Peel or placebo on the facial treatment area.

The surface area of the intended treatment area was determined (up to 200 cm2). A thin layer (approximately 1 mm or the thickness of a dime) of the study drug was applied evenly across the area to be treated. The study drug was applied for 20 minutes (±2 minutes).

Immediately following removal of the study drug, the investigator performed an evaluation of skin reactions, assessing the treatment area for erythema, edema and blanching or any other adverse skin reaction.

Study Design

Study Type:

Interventional

Actual Enrollment :

80 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Jun 1, 2005

Actual Primary Completion Date :

Oct 1, 2005

Actual Study Completion Date :

Oct 1, 2005

Arms and Interventions

Arm	Intervention/Treatment
Experimental: S-Caine Peel	Drug: S-Caine™ Peel (lidocaine and tetracaine topical cream 7%/7%) 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). Other Names: Pliaglis
Placebo Comparator: Placebo Peel	Drug: Placebo Peel Placebo Peel applied topically at approximately 1 mm in thickness and remained on the treatment area for 20 minutes (±2 minutes). Other Names: Placebo

Arm

Intervention/Treatment

Experimental: S-Caine Peel

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

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).

Other Names:

Pliaglis

Placebo Comparator: Placebo Peel

Drug: Placebo Peel

Placebo Peel applied topically at approximately 1 mm in thickness and remained on the treatment area for 20 minutes (±2 minutes).

Other Names:

Placebo

Outcome Measures

Primary Outcome Measures

Pain Intensity [20 minutes]
Patient's evaluation of procedural pain intensity using the 100 mm Visual Analog Scale (VAS).

Secondary Outcome Measures

Number of participants with adverse events [20 minutes]
To monitor the nature and frequency of adverse events (AEs) associated with the application of S-Caine Peel

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Patient is 18 years of age or older
Patient elects to undergo PDL therapy for the treatment of vascular lesions on the face

Exclusion Criteria:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Washington Institute of Dermatologic Laser Surgery	Washington	District of Columbia	United States	20037
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

Sponsors and Collaborators

ZARS Pharma Inc.

Investigators

Principal Investigator: Tina Alster, MD, Washington Institute of Dermatologic Laser Surgery

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

ZARS Pharma Inc.

ClinicalTrials.gov Identifier:

NCT00110773

Other Study ID Numbers:

SCP-42-05

First Posted:

May 13, 2005

Last Update Posted:

Jun 5, 2012

Last Verified:

Jun 1, 2012

Additional relevant MeSH terms:

Lidocaine

Tetracaine

Study Results

No Results Posted as of Jun 5, 2012