NCT00110734

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at below P25 for phase_3 pain

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 12, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 13, 2005

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2005

Completed
Last Updated

September 23, 2005

Status Verified

September 1, 2005

First QC Date

May 12, 2005

Last Update Submit

September 21, 2005

Conditions

Pain

Outcome Measures

Primary Outcomes (1)

  • 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 (1)

  • To monitor the nature and frequency of adverse events (AEs) associated with the application of S-Caine Peel

Interventions

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

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 previous clinical trial involving S-Caine Peel

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Laser and Skin Surgery Center of New York

New York, New York, 10016, United States

Location

MeSH Terms

Conditions

Pain

Interventions

Lidocaine

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

AcetanilidesAnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

May 12, 2005

First Posted

May 13, 2005

Study Completion

September 1, 2005

Last Updated

September 23, 2005

Record last verified: 2005-09

Locations

US(1)