Comparison Study on Topical Anesthetic Agents (LMX4 and BLT) Prior to Fractional Skin Resurfacing

NCT01842373 | Withdrawn DMC

• 1 other identifier: 41491
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this research study is to test which topical anesthesia: LMX4 (Lidocaine 4%) or BLT (Benzocaine 20%, Lidocaine 6%, and Tetracaine 4%) is more effective in reducing discomfort during treatment with the Fraxel DUAL 1550/1927 (Solta Medical, Hayward, CA). No studies have been done on the effectiveness of LMX4 versus BLT using the Fraxel DUAL, although individually LMX4, BLT, and the Fraxel DUAL have been studied extensively. The hypothesis is that there will be no clinical difference between the two topical anesthetics.

Conditions

Pain

Keywords

topical anesthetics; laser resurfacing

Outcome Measures

Primary Outcomes (1)

• Patient Assessment of Pain

  A pain assessment will be performed on both halves of the face by utilizing a standard 10 cm visual analog pain scale (VAS).

  Immediately after laser treatment

Study Arms (2)

LMX4

EXPERIMENTAL

3 g of LMX4 will be applied to one half of the face for 60 minutes

Drug: BLT

BLT

ACTIVE COMPARATOR

3 g of BLT will be applied to half of face for 60 minutes

Drug: LMX4

Interventions

LMX4 DRUG

Also known as: LMX 4 (Lidocaine 4%)

BLT

BLT DRUG

Also known as: BLT (Benzocaine 20%, lidocaine 6%, tetracaine 4%)

LMX4

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• At least 28 subjects will be included in this study.
• Subjects capable of giving informed consent.
• Patients 18 years of age and older will be included in this study.
• Any patient seeking Fraxel DUAL1550/1927 (Solta Medical) treatment on the face for rhytids, photoaging, hyperpigmentation, and acne scarring at the Hershey Medical Center dermatology clinics will be asked to participate.

You may not qualify if:

• Age \<18
• Allergy to lidocaine or tetracaine
• Women who are pregnant or breast-feeding
• Patients with cardiac or respiratory disease, seizure disorders, or neuropathy
• Patients currently taking anxiolytics and opiates

Sponsors & Collaborators

• Milton S. Hershey Medical Center: lead
• Solta Medical: collaborator

Study Sites (1)

Milton S. Hershey Medical Center

Hershey, Pennsylvania, 17033, United States

Location

MeSH Terms

Conditions

Pain

Interventions

Receptors, Leukotriene B4; Benzocaine; Lidocaine

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Receptors, Leukotriene; Receptors, Eicosanoid; Receptors, G-Protein-Coupled; Receptors, Cell Surface; Membrane Proteins; Proteins; Amino Acids, Peptides, and Proteins; para-Aminobenzoates; Aminobenzoates; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Acetanilides; Anilides; Amides; Aniline Compounds; Amines

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident Physician

Study Record Dates

• First Submitted: April 25, 2013
• First Posted: April 29, 2013
• Study Start: July 1, 2013
• Primary Completion: September 1, 2013
• Study Completion: December 1, 2013
• Last Updated: January 25, 2017

Record last verified: 2017-01

Locations

US (1)