PainNCT01842373
Comparison Study on Topical Anesthetic Agents (LMX4 and BLT) Prior to Fractional Skin Resurfacing
A study testing LMX4 and BLT in people with Pain, run by Milton S. Hershey Medical Center at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Pain
- What is being tested?
- LMX4 and BLT
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2013to Dec 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Milton S. Hershey Medical Center
Hershey, Pennsylvania, 17033
About this study
Official title: A Double-Blind, Randomized, Split-Face Comparison Trial on Topical Anesthetic Agents Prior to Fractional Skin Resurfacing
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.
Read the detailed description
Lasers can be effectively utilized for facial rejuvenation, reduction of photoinduced rhytides, and dyschromia. Topical anesthetics are used to minimize the discomfort associated with laser induced thermal pain. There are currently several formulations of topical anesthesia. However, studies comparing the products are limited especially for the new formulations that claim increased efficacy and faster onset.
LMX4 (Ferndale Laboratories, Ferndale, Michigan) is over the counter topical anesthesia. It is 4% lidocaine that has been formulated into multilamellar vesicles containing several lipid bilayers. This unique liposomal-based delivery system has been reported to deliver a greater concentration of drug. This results in a longer duration of activity and faster onset of action without requiring occlusion.4 Liposomes assist with drug penetration because the skin is lipid bilayer that can encapsulate the drug.
BLT is a compounded topical anesthetic containing 20% benzocaine, 6% lidocaine, and 4% tetracaine. It is commonly prescribed as topical anesthesia. All BLT products will be compounded at the University Physicians Center Pharmacy to ensure safety and uniformity. Anecdotally, some physicians claim it is the topical anesthesia of choice prior to laser surgery.
The objective of the study is to evaluate the clinical efficacy of topical anesthetic compounds prior to fractional skin resurfacing.
- Conditions
- Pain
- Being tested
- LMX4, BLT
- Keywords
- topical anesthetics, laser resurfacing
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LMX4Drug
Also called LMX 4 (Lidocaine 4%)
BLTDrug
Also called BLT (Benzocaine 20%, lidocaine 6%, tetracaine 4%)
| Study group | Role | What they receive |
|---|---|---|
| LMX4 | Experimental | 3 g of LMX4 will be applied to one half of the face for 60 minutes Receives: Drug: BLT |
| BLT | Active comparator | 3 g of BLT will be applied to half of face for 60 minutes Receives: Drug: LMX4 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Immediately after laser treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2013 (estimated)
- Study startJul 2013
- Primary completionSep 2013 (estimated)
- Study completionDec 2013 (estimated)
Why it stopped: Funding not secured
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies of the same condition, open and under way.
- More trials run by Milton S. Hershey Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Milton S. Hershey Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Solta Medical
- Responsible party
- Principal investigator, Charlene Lam, Milton S. Hershey Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01842373
- Sponsor's protocol ID
- 41491
- Status last verified
- Jan 2017
- First submitted
- 25 Apr 2013
- Last updated
- 25 Jan 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-Blind, Randomized, Split-Face Comparison Trial on Topical Anesthetic Agents Prior to Fractional Skin Resurfacing
- ClinicalTrials.gov ID
- NCT01842373
- Acronym / sponsor ID
- 41491
- Conditions
- Pain
- Keywords
- topical anesthetics, laser resurfacing
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Funding not secured
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Milton S. Hershey Medical CenterUniversity, hospital or other
- Collaborators
- Solta Medical
- Study start
- Jul 2013
- Primary completion
- Sep 2013 (estimated)
- Study completion
- Dec 2013 (estimated)
- First posted
- 29 Apr 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Lasers can be effectively utilized for facial rejuvenation, reduction of photoinduced rhytides, and dyschromia. Topical anesthetics are used to minimize the discomfort associated with laser induced thermal pain. There are currently several formulations of topical anesthesia. However, studies comparing the products are limited especially for the new formulations that claim increased efficacy and faster onset.
LMX4 (Ferndale Laboratories, Ferndale, Michigan) is over the counter topical anesthesia. It is 4% lidocaine that has been formulated into multilamellar vesicles containing several lipid bilayers. This unique liposomal-based delivery system has been reported to deliver a greater concentration of drug. This results in a longer duration of activity and faster onset of action without requiring occlusion.4 Liposomes assist with drug penetration because the skin is lipid bilayer that can encapsulate the drug.
BLT is a compounded topical anesthetic containing 20% benzocaine, 6% lidocaine, and 4% tetracaine. It is commonly prescribed as topical anesthesia. All BLT products will be compounded at the University Physicians Center Pharmacy to ensure safety and uniformity. Anecdotally, some physicians claim it is the topical anesthesia of choice prior to laser surgery.
The objective of the study is to evaluate the clinical efficacy of topical anesthetic compounds prior to fractional skin resurfacing.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LMX4 | Experimental | Drug: BLT3 g of LMX4 will be applied to one half of the face for 60 minutes |
| BLT | Active comparator | Drug: LMX43 g of BLT will be applied to half of face for 60 minutes |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LMX4Also: LMX 4 (Lidocaine 4%) | Drug | BLT |
| BLTAlso: BLT (Benzocaine 20%, lidocaine 6%, tetracaine 4%) | Drug | LMX4 |
Primary outcome
Patient Assessment of Pain
Time frame: Immediately after laser treatment
A pain assessment will be performed on both halves of the face by utilizing a standard 10 cm visual analog pain scale (VAS).
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LMX4 and BLT in people with Pain, run by Milton S. Hershey Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 25 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient Assessment of Pain (time frame: Immediately after laser treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jan 2017.