S-Caine™ Peel (Skin Numbing Cream) to Treat Pain During L... | NCT00110734

Studies
S-Caine™ Peel (Skin Numbing Cream) to Treat Pain During Laser-Assisted Tattoo Removal in Adults

NCT00110734

Sponsor

ZARS Pharma Inc.

Status

Completed

Last Update Posted

Sep 23, 2005Estimated

Enrollment

Phase

Phase 3

Conditions

Pain

Interventions

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

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2005

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Not provided

Start Date

Not provided

Primary Completion Date

Not provided

Completion Date

Sep 2005

First Submitted Date

May 12, 2005

First Submission Date that Met QC Criteria

May 12, 2005

First Posted Date

May 13, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 21, 2005

Last Update Posted Date

Sep 23, 2005Estimated

Description Module

Brief Summary

There is pain associated with laser-assisted tattoo removal. For this reason, some form of anesthesia is commonly used to eliminate or minimize the pain. This anesthesia is usually a topical local anesthetic cream or ointment spread over the skin. The purpose of this study is to further estimate the effectiveness of S-Caine™ Peel (lidocaine 7% and tetracaine 7% cream) for treating pain during laser-assisted tattoo removal.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

Name	Type	Description	Arm Group Labels	Other Names
S-Caine™ Peel (lidocaine and tetracaine cream 7%/7%)	Drug

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
To evaluate the efficacy of S-Caine Peel when applied for 60 minutes for induction of local dermal anesthesia prior to laser-assisted tattoo removal in adults

Secondary Outcomes

Measure	Description	Time Frame
To monitor the nature and frequency of adverse events (AEs) associated with the application of S-Caine Peel

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patient is 18 years of age or older
Patient elects to undergo laser-assisted tattoo removal

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 previous clinical trial involving S-Caine Peel

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Laser and Skin Surgery Center of New York		New York	New York	10016	United States

Condition Browse Module

MeSH Terms

ID	Term
D010146	Pain

Ancestor Terms

ID	Term
D009461	Neurologic Manifestations
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D008012	Lidocaine

Ancestor Terms

ID	Term
D000083	Acetanilides
D000813	Anilides
D000577	Amides
D009930	Organic Chemicals
D000814

Browse Leaves

Not provided

Browse Branches

Not provided