Local Anesthesia of the SkinPhase 4NCT03279757
Fractional Laser Assisted Delivery of Anesthetics IIIb
A Phase 4 study testing AHES 5 minutes, AHES 15 minutes and AHES 25 minutes in people with Local Anesthesia of the Skin, run by Netherlands Institute for Pigment Disorders.
Trial summary
The purpose of this study are to compare the efficacy of two different commercially available local anesthetics on AFXL pretreated skin and to assess the role of the application time in this technique. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Local Anesthesia of the Skin
- What is being tested?
- AHES 5 minutes, AHES 15 minutes and AHES 25 minutes
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2016to 1 Dec 2016
- Phase
- Phase 4
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Fitzpatrick skin type I or II
- Age ≥18 years
- Patient is willing and able to give written informed consent
Who cannot join
- History of keloid or hypertrophic scar formation or complicated wound healing
- Presence of any active skin disease
- Known allergy to local anesthesia
- Pregnancy or lactation
- Incompetency to understand what the procedure involves
- Current complaints of chronic pain or other alterations in pain sensation (e.g. due to diabetes mellitus or lepra)
Show all 10Show fewer
- Current treatment with systemic analgesics or other medication that can influence pain sensation
- Current treatment with anticoagulants
- Fitzpatrick skin type III-VI
- Excessive sun tan
About this study
Official title: Parameters in Fractional Laser Assisted Delivery of Topical Anesthetics: Role of Anesthetic and Application Time
The purpose of this study are to compare the efficacy of two different commercially available local anesthetics on AFXL pretreated skin and to assess the role of the application time in this technique.
Read the detailed description
Rationale: In dermatology anesthetics are frequently injected or topically applied to achieve local anesthesia. Injectable anesthetics are effective but uncomfortable during administration, especially for people who are needle phobic. Application of topical anesthesia is painless but time consuming and often only partial aesthesia is achieved due to the barrier function of the stratum corneum. (Manuskiatti, Triwongwaranat et al. 2010) Penetration of local anesthetics could be enhanced by pretreatment of the skin with ablative fractional lasers (AFXL) which locally disrupts the stratum corneum by creating an array of microscopic ablation channels. (Sklar, Burnett et al. 2014) In a previous pilot study, conducted at our institute, we demonstrated that effective anesthesia could be achieved within ten minutes after application of a topical anesthetic on skin pretreated with AFXL at painless settings. (Meesters, Bakker et al. 2015) However, little is still known about the role of the type of anesthetic the type of anesthetic and the application time on the efficacy of the anesthesia.
Objective: The objective of this study is to compare the efficacy of two different commercially available local anesthetics on AFXL pretreated skin, a low concentration articaine solution and a high concentration lidocaine/tetracaine cream. We also aim to compare the efficacy of AFXL assisted topical anesthesia after various different application times.
Study design: Prospective, single blinded, randomized, controlled, within subject, pilot study.
Study population: 15 healthy volunteers ≥18 years, who give written informed consent
Intervention: In each subject, six test regions on subject's back of 1x1 cm will be pretreated with the fractional carbon dioxide (CO2) laser at 2.5 mJ and 15% density and will be randomly allocated to application of (I) articaine hydrochloride 40 mg/ml + epinephrine 10 μg/ml 30 solution (AHES) (5 minutes application time), (II) AHES (15 minutes application time), (III) AHES (25 minutes application time), (IV) lidocaine 70 mg/g + tetracaine 70 mg/g cream (LTC) (5 minutes application time, (V) LTC (15 minutes application time), (VI) LTC (25 minutes application time). After 15 minutes a pain stimulus, consisting of a pass with the fractional CO2 laser at 50 mJ and 5% density (scanned area 6x6 mm), will be given at each test region. In addition, a reference pain stimulus with the CO2 laser at the same settings will be given at unanesthetized skin. Subjects will be asked to indicate pain on a visual analogue scale (VAS) from 0-10 (0: no pain; 10: worst imaginable pain) directly after each pain stimulus
- Conditions
- Local Anesthesia of the Skin
- Being tested
- AHES 5 minutes, AHES 15 minutes, AHES 25 minutes, LTC 5 minutes, LTC 15 minutes
- Keywords
- Fractional laser, Topical anesthesia, Drug delivery, CO2 laser
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AHES 5 minutesDrug
Also called Ultracain D-S forte, Articaine hydrochloride 40 mg/ml + epinephrine 10 μg/ml
Topical application of AHES with 5 minutes application time After 5 minutes: pain stimulus with the fractional CO2 laser, 50 mJ, 5% density
AHES 15 minutesDrug
Also called Ultracain D-S forte, Articaine hydrochloride 40 mg/ml + epinephrine 10 μg/ml
Topical application of AHES with 15 minutes application time After 15 minutes: pain stimulus with the fractional CO2 laser, 50 mJ, 5% density
AHES 25 minutesDrug
Also called Ultracain D-S forte, Articaine hydrochloride 40 mg/ml + epinephrine 10 μg/ml
Topical application of AHES with 25 minutes application time After 25 minutes: pain stimulus with the fractional CO2 laser, 50 mJ, 5% density
LTC 5 minutesDrug
Also called Pliaglis cream, Lidocaine 70 mg/g + tetracaine 70 mg/g cream
Topical application of LTC with 5 minutes application time After 5 minutes: pain stimulus with the fractional CO2 laser, 50 mJ, 5% density
LTC 15 minutesDrug
Also called Pliaglis cream, Lidocaine 70 mg/g + tetracaine 70 mg/g cream
Topical application of LTC with 15 minutes application time After 15 minutes: pain stimulus with the fractional CO2 laser, 50 mJ, 5% density
LTC 25 minutesDrug
Also called Pliaglis cream, Lidocaine 70 mg/g + tetracaine 70 mg/g cream
Topical application of LTC with 25 minutes application time After 25 minutes: pain stimulus with the fractional CO2 laser, 50 mJ, 5% density
fractional CO2 laser, 50 mJ, 5% densityDevice
Also called Fractional carbon dioxide laser, UltraPulse®, DeepFx handpiece; Lumenis Inc., Ablative fractional laser
Pain stimulus with the fractional CO2 laser, 50 mJ, 5% density
| Study group | Role | What they receive |
|---|---|---|
| AHES 5 minutes | Experimental | This test region will be pretreated with a fractional carbon dioxide laser with a 120 μm spot at 15% density and a pulse energy of 2.5 mJ/microbeam (Fractional CO2 laser, 2.5 mJ, 15% density) in a subject blinded fashion. After pretreatment articaine hydrochloride 40 mg/ml + epinephrine 10 μg/ml solution (AHES) will be applied at this test region. 5 minutes after AHES application (under occlusion), a pain stimulus will be given at the test region with the fractional CO2 laser, 50 mJ, 5% density. Receives: Drug: AHES 5 minutes; Device: fractional CO2 laser, 50 mJ, 5% density |
| AHES 15 minutes | Experimental | This test region will be pretreated with a fractional carbon dioxide laser with a 120 μm spot at 15% density and a pulse energy of 2.5 mJ/microbeam (Fractional CO2 laser, 2.5 mJ, 15% density) in a subject blinded fashion. After pretreatment articaine hydrochloride 40 mg/ml + epinephrine 10 μg/ml solution (AHES) will be applied at this test region. 15 minutes after AHES application (under occlusion), a pain stimulus will be given at the test region with the fractional CO2 laser, 50 mJ, 5% density. Receives: Drug: AHES 15 minutes; Device: fractional CO2 laser, 50 mJ, 5% density |
| AHES 25 minutes | Experimental | This test region will be pretreated with a fractional carbon dioxide laser with a 120 μm spot at 15% density and a pulse energy of 2.5 mJ/microbeam (Fractional CO2 laser, 2.5 mJ, 15% density) in a subject blinded fashion. After pretreatment articaine hydrochloride 40 mg/ml + epinephrine 10 μg/ml solution (AHES) will be applied at this test region. 25 minutes after AHES application (under occlusion), a pain stimulus will be given at the test region with the fractional CO2 laser, 50 mJ, 5% density. Receives: Drug: AHES 25 minutes; Device: fractional CO2 laser, 50 mJ, 5% density |
| LTC 5 minutes | Experimental | This test region will be pretreated with a fractional carbon dioxide laser with a 120 μm spot at 15% density and a pulse energy of 2.5 mJ/microbeam (Fractional CO2 laser, 2.5 mJ, 15% density) in a subject blinded fashion. After pretreatment lidocaine 70 mg/g + tetracaine 70 mg/g cream (LTC) will be applied at this test region. 5 minutes after LTC application (under occlusion), a pain stimulus will be given at the test region with the fractional CO2 laser, 50 mJ, 5% density. Receives: Drug: LTC 5 minutes; Device: fractional CO2 laser, 50 mJ, 5% density |
| LTC 15 minutes | Experimental | This test region will be pretreated with a fractional carbon dioxide laser with a 120 μm spot at 15% density and a pulse energy of 2.5 mJ/microbeam (Fractional CO2 laser, 2.5 mJ, 15% density) in a subject blinded fashion. After pretreatment lidocaine 70 mg/g + tetracaine 70 mg/g cream (LTC) will be applied at this test region. 15 minutes after LTC application (under occlusion), a pain stimulus will be given at the test region with the fractional CO2 laser, 50 mJ, 5% density. Receives: Drug: LTC 15 minutes; Device: fractional CO2 laser, 50 mJ, 5% density |
| LTC 25 minutes | Experimental | This test region will be pretreated with a fractional carbon dioxide laser with a 120 μm spot at 15% density and a pulse energy of 2.5 mJ/microbeam (Fractional CO2 laser, 2.5 mJ, 15% density) in a subject blinded fashion. After pretreatment lidocaine 70 mg/g + tetracaine 70 mg/g cream (LTC) will be applied at this test region. 25 minutes after LTC application (under occlusion), a pain stimulus will be given at the test region with the fractional CO2 laser, 50 mJ, 5% density. Receives: Drug: LTC 25 minutes; Device: fractional CO2 laser, 50 mJ, 5% density |
| Unanesthetized skin | Other | A pain stimulus will be given at unanesthetized skin with the fractional CO2 laser, 50 mJ, 5% density Receives: Device: fractional CO2 laser, 50 mJ, 5% density |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain score
The main study parameter is pain, as scored on a VAS from 0-10 (0: no pain; 10: worst imaginable pain).
Measured: After 5 minutes application time of the anesthetics
Pain score
The main study parameter is pain, as scored on a VAS from 0-10 (0: no pain; 10: worst imaginable pain).
Measured: After 15 minutes application time of the anesthetics
Pain score
The main study parameter is pain, as scored on a VAS from 0-10 (0: no pain; 10: worst imaginable pain).
Measured: After 25 minutes application time of the anesthetics
Secondary outcomes (1)
Pain score
The secondary study parameter is pain, as scored on a VAS from 0-10 (0: no pain; 10: worst imaginable pain) directly after pretreatment
Measured: Directly after pretreatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2017
- Study start1 Oct 2016
- Primary completion1 Dec 2016
- Study completion1 Dec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (17)Papers the sponsor has linked to this study.
- Other trials for Local Anesthesia of the SkinStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Netherlands Institute for Pigment Disorders
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Albert Wolkerstorfer, MD, PhD, Principal investigator, Netherlands Institute for Pigment Disorders, Department of Dermatology, Academic Medical Center, University of AmsterdamMenno A De Rie, MD, PhD, Study director, Department of Dermatology, Academic Medical Center, University of Amsterdam
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03279757
- Sponsor's protocol ID
- NL53766.018.15b
- Status last verified
- Sep 2017
- First submitted
- 3 Sep 2017
- Last updated
- 12 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Meesters AA, Bakker MM, de Rie MA, Wolkerstorfer A. Fractional CO2 laser assisted delivery of topical anesthetics: A randomized controlled pilot study. Lasers Surg Med. 2016 Feb;48(2):208-11. doi: 10.1002/lsm.22376. Epub 2015 May 29.
PubMed 26032635Sklar LR, Burnett CT, Waibel JS, Moy RL, Ozog DM. Laser assisted drug delivery: a review of an evolving technology. Lasers Surg Med. 2014 Apr;46(4):249-62. doi: 10.1002/lsm.22227. Epub 2014 Mar 24.
PubMed 24664987Oni G, Brown SA, Kenkel JM. Can fractional lasers enhance transdermal absorption of topical lidocaine in an in vivo animal model? Lasers Surg Med. 2012 Feb;44(2):168-74. doi: 10.1002/lsm.21130. Epub 2012 Feb 2.
PubMed 22302761Oni G, Rasko Y, Kenkel J. Topical lidocaine enhanced by laser pretreatment: a safe and effective method of analgesia for facial rejuvenation. Aesthet Surg J. 2013 Aug 1;33(6):854-61. doi: 10.1177/1090820X13496248.
PubMed 23908302Ong MW, Bashir SJ. Fractional laser resurfacing for acne scars: a review. Br J Dermatol. 2012 Jun;166(6):1160-9. doi: 10.1111/j.1365-2133.2012.10870.x. Epub 2012 May 8.
PubMed 22296284Manuskiatti W, Triwongwaranat D, Varothai S, Eimpunth S, Wanitphakdeedecha R. Efficacy and safety of a carbon-dioxide ablative fractional resurfacing device for treatment of atrophic acne scars in Asians. J Am Acad Dermatol. 2010 Aug;63(2):274-83. doi: 10.1016/j.jaad.2009.08.051.
PubMed 20633798Wolfe JW, Butterworth JF. Local anesthetic systemic toxicity: update on mechanisms and treatment. Curr Opin Anaesthesiol. 2011 Oct;24(5):561-6. doi: 10.1097/ACO.0b013e32834a9394.
PubMed 21841477Hahn IH, Hoffman RS, Nelson LS. EMLA-induced methemoglobinemia and systemic topical anesthetic toxicity. J Emerg Med. 2004 Jan;26(1):85-8. doi: 10.1016/j.jemermed.2003.03.003.
PubMed 14751483Haedersdal M, Sakamoto FH, Farinelli WA, Doukas AG, Tam J, Anderson RR. Fractional CO(2) laser-assisted drug delivery. Lasers Surg Med. 2010 Feb;42(2):113-22. doi: 10.1002/lsm.20860.
PubMed 20166154Bachhav YG, Heinrich A, Kalia YN. Controlled intra- and transdermal protein delivery using a minimally invasive Erbium:YAG fractional laser ablation technology. Eur J Pharm Biopharm. 2013 Jun;84(2):355-64. doi: 10.1016/j.ejpb.2012.11.018. Epub 2012 Nov 30.
PubMed 23207321Haak CS, Farinelli WA, Tam J, Doukas AG, Anderson RR, Haedersdal M. Fractional laser-assisted delivery of methyl aminolevulinate: Impact of laser channel depth and incubation time. Lasers Surg Med. 2012 Dec;44(10):787-95. doi: 10.1002/lsm.22102. Epub 2012 Dec 4.
PubMed 23212624Haak CS, Bhayana B, Farinelli WA, Anderson RR, Haedersdal M. The impact of treatment density and molecular weight for fractional laser-assisted drug delivery. J Control Release. 2012 Nov 10;163(3):335-41. doi: 10.1016/j.jconrel.2012.09.008. Epub 2012 Sep 21.
PubMed 23000695Tierney EP, Hanke CW. Fractionated carbon dioxide laser treatment of photoaging: prospective study in 45 patients and review of the literature. Dermatol Surg. 2011 Sep;37(9):1279-90. doi: 10.1111/j.1524-4725.2011.02082.x.
PubMed 22988990Paasch U, Haedersdal M. Laser systems for ablative fractional resurfacing. Expert Rev Med Devices. 2011 Jan;8(1):67-83. doi: 10.1586/erd.10.74.
PubMed 21158542Farkas JP, Richardson JA, Burrus CF, Hoopman JE, Brown SA, Kenkel JM. In vivo histopathologic comparison of the acute injury following treatment with five fractional ablative laser devices. Aesthet Surg J. 2010 May-Jun;30(3):457-64. doi: 10.1177/1090820X10373060.
PubMed 20601578
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Parameters in Fractional Laser Assisted Delivery of Topical Anesthetics: Role of Anesthetic and Application Time
- ClinicalTrials.gov ID
- NCT03279757
- Acronym / sponsor ID
- NL53766.018.15b
- Conditions
- Local Anesthesia of the Skin
- Keywords
- Fractional laser, Topical anesthesia, Drug delivery, CO2 laser
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Netherlands Institute for Pigment DisordersUniversity, hospital or other
- Study start
- 1 Oct 2016 (actual)
- Primary completion
- 1 Dec 2016 (actual)
- Study completion
- 1 Dec 2016 (actual)
- First posted
- 12 Sep 2017 (actual)
- 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 study are to compare the efficacy of two different commercially available local anesthetics on AFXL pretreated skin and to assess the role of the application time in this technique.
Detailed description
Rationale: In dermatology anesthetics are frequently injected or topically applied to achieve local anesthesia. Injectable anesthetics are effective but uncomfortable during administration, especially for people who are needle phobic. Application of topical anesthesia is painless but time consuming and often only partial aesthesia is achieved due to the barrier function of the stratum corneum. (Manuskiatti, Triwongwaranat et al. 2010) Penetration of local anesthetics could be enhanced by pretreatment of the skin with ablative fractional lasers (AFXL) which locally disrupts the stratum corneum by creating an array of microscopic ablation channels. (Sklar, Burnett et al. 2014) In a previous pilot study, conducted at our institute, we demonstrated that effective anesthesia could be achieved within ten minutes after application of a topical anesthetic on skin pretreated with AFXL at painless settings. (Meesters, Bakker et al. 2015) However, little is still known about the role of the type of anesthetic the type of anesthetic and the application time on the efficacy of the anesthesia.
Objective: The objective of this study is to compare the efficacy of two different commercially available local anesthetics on AFXL pretreated skin, a low concentration articaine solution and a high concentration lidocaine/tetracaine cream. We also aim to compare the efficacy of AFXL assisted topical anesthesia after various different application times.
Study design: Prospective, single blinded, randomized, controlled, within subject, pilot study.
Study population: 15 healthy volunteers ≥18 years, who give written informed consent
Intervention: In each subject, six test regions on subject's back of 1x1 cm will be pretreated with the fractional carbon dioxide (CO2) laser at 2.5 mJ and 15% density and will be randomly allocated to application of (I) articaine hydrochloride 40 mg/ml + epinephrine 10 μg/ml 30 solution (AHES) (5 minutes application time), (II) AHES (15 minutes application time), (III) AHES (25 minutes application time), (IV) lidocaine 70 mg/g + tetracaine 70 mg/g cream (LTC) (5 minutes application time, (V) LTC (15 minutes application time), (VI) LTC (25 minutes application time). After 15 minutes a pain stimulus, consisting of a pass with the fractional CO2 laser at 50 mJ and 5% density (scanned area 6x6 mm), will be given at each test region. In addition, a reference pain stimulus with the CO2 laser at the same settings will be given at unanesthetized skin. Subjects will be asked to indicate pain on a visual analogue scale (VAS) from 0-10 (0: no pain; 10: worst imaginable pain) directly after each pain stimulus
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (participant)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| AHES 5 minutes | Experimental | Drug: AHES 5 minutes, Device: fractional CO2 laser, 50 mJ, 5% densityThis test region will be pretreated with a fractional carbon dioxide laser with a 120 μm spot at 15% density and a pulse energy of 2.5 mJ/microbeam (Fractional CO2 laser, 2.5 mJ, 15% density) in a subject blinded fashion. After pretreatment articaine hydrochloride 40 mg/ml + epinephrine 10 μg/ml solution (AHES) will be applied at this test region. 5 minutes after AHES application (under occlusion), a pain stimulus will be given at the test region with the fractional CO2 laser, 50 mJ, 5% density. |
| AHES 15 minutes | Experimental | Drug: AHES 15 minutes, Device: fractional CO2 laser, 50 mJ, 5% densityThis test region will be pretreated with a fractional carbon dioxide laser with a 120 μm spot at 15% density and a pulse energy of 2.5 mJ/microbeam (Fractional CO2 laser, 2.5 mJ, 15% density) in a subject blinded fashion. After pretreatment articaine hydrochloride 40 mg/ml + epinephrine 10 μg/ml solution (AHES) will be applied at this test region. 15 minutes after AHES application (under occlusion), a pain stimulus will be given at the test region with the fractional CO2 laser, 50 mJ, 5% density. |
| AHES 25 minutes | Experimental | Drug: AHES 25 minutes, Device: fractional CO2 laser, 50 mJ, 5% densityThis test region will be pretreated with a fractional carbon dioxide laser with a 120 μm spot at 15% density and a pulse energy of 2.5 mJ/microbeam (Fractional CO2 laser, 2.5 mJ, 15% density) in a subject blinded fashion. After pretreatment articaine hydrochloride 40 mg/ml + epinephrine 10 μg/ml solution (AHES) will be applied at this test region. 25 minutes after AHES application (under occlusion), a pain stimulus will be given at the test region with the fractional CO2 laser, 50 mJ, 5% density. |
| LTC 5 minutes | Experimental | Drug: LTC 5 minutes, Device: fractional CO2 laser, 50 mJ, 5% densityThis test region will be pretreated with a fractional carbon dioxide laser with a 120 μm spot at 15% density and a pulse energy of 2.5 mJ/microbeam (Fractional CO2 laser, 2.5 mJ, 15% density) in a subject blinded fashion. After pretreatment lidocaine 70 mg/g + tetracaine 70 mg/g cream (LTC) will be applied at this test region. 5 minutes after LTC application (under occlusion), a pain stimulus will be given at the test region with the fractional CO2 laser, 50 mJ, 5% density. |
| LTC 15 minutes | Experimental | Drug: LTC 15 minutes, Device: fractional CO2 laser, 50 mJ, 5% densityThis test region will be pretreated with a fractional carbon dioxide laser with a 120 μm spot at 15% density and a pulse energy of 2.5 mJ/microbeam (Fractional CO2 laser, 2.5 mJ, 15% density) in a subject blinded fashion. After pretreatment lidocaine 70 mg/g + tetracaine 70 mg/g cream (LTC) will be applied at this test region. 15 minutes after LTC application (under occlusion), a pain stimulus will be given at the test region with the fractional CO2 laser, 50 mJ, 5% density. |
| LTC 25 minutes | Experimental | Drug: LTC 25 minutes, Device: fractional CO2 laser, 50 mJ, 5% densityThis test region will be pretreated with a fractional carbon dioxide laser with a 120 μm spot at 15% density and a pulse energy of 2.5 mJ/microbeam (Fractional CO2 laser, 2.5 mJ, 15% density) in a subject blinded fashion. After pretreatment lidocaine 70 mg/g + tetracaine 70 mg/g cream (LTC) will be applied at this test region. 25 minutes after LTC application (under occlusion), a pain stimulus will be given at the test region with the fractional CO2 laser, 50 mJ, 5% density. |
| Unanesthetized skin | Other | Device: fractional CO2 laser, 50 mJ, 5% densityA pain stimulus will be given at unanesthetized skin with the fractional CO2 laser, 50 mJ, 5% density |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Fitzpatrick skin type I or II
- Age ≥18 years
- Patient is willing and able to give written informed consent
Key exclusion criteria (10 listed)
- History of keloid or hypertrophic scar formation or complicated wound healing
- Presence of any active skin disease
- Known allergy to local anesthesia
- Pregnancy or lactation
- Incompetency to understand what the procedure involves
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 |
|---|---|---|
| AHES 5 minutesAlso: Ultracain D-S forte, Articaine hydrochloride 40 mg/ml + epinephrine 10 μg/mlTopical application of AHES with 5 minutes application time After 5 minutes: pain stimulus with the fractional CO2 laser, 50 mJ, 5% density | Drug | AHES 5 minutes |
| AHES 15 minutesAlso: Ultracain D-S forte, Articaine hydrochloride 40 mg/ml + epinephrine 10 μg/mlTopical application of AHES with 15 minutes application time After 15 minutes: pain stimulus with the fractional CO2 laser, 50 mJ, 5% density | Drug | AHES 15 minutes |
| AHES 25 minutesAlso: Ultracain D-S forte, Articaine hydrochloride 40 mg/ml + epinephrine 10 μg/mlTopical application of AHES with 25 minutes application time After 25 minutes: pain stimulus with the fractional CO2 laser, 50 mJ, 5% density | Drug | AHES 25 minutes |
| LTC 5 minutesAlso: Pliaglis cream, Lidocaine 70 mg/g + tetracaine 70 mg/g creamTopical application of LTC with 5 minutes application time After 5 minutes: pain stimulus with the fractional CO2 laser, 50 mJ, 5% density | Drug | LTC 5 minutes |
| LTC 15 minutesAlso: Pliaglis cream, Lidocaine 70 mg/g + tetracaine 70 mg/g creamTopical application of LTC with 15 minutes application time After 15 minutes: pain stimulus with the fractional CO2 laser, 50 mJ, 5% density | Drug | LTC 15 minutes |
| LTC 25 minutesAlso: Pliaglis cream, Lidocaine 70 mg/g + tetracaine 70 mg/g creamTopical application of LTC with 25 minutes application time After 25 minutes: pain stimulus with the fractional CO2 laser, 50 mJ, 5% density | Drug | LTC 25 minutes |
| fractional CO2 laser, 50 mJ, 5% densityAlso: Fractional carbon dioxide laser, UltraPulse®, DeepFx handpiece; Lumenis Inc., Ablative fractional laserPain stimulus with the fractional CO2 laser, 50 mJ, 5% density | Device | AHES 15 minutes, AHES 25 minutes, AHES 5 minutes, LTC 15 minutes, LTC 25 minutes, LTC 5 minutes, Unanesthetized skin |
Primary outcome
Pain score
Time frame: After 5 minutes application time of the anesthetics
The main study parameter is pain, as scored on a VAS from 0-10 (0: no pain; 10: worst imaginable pain).
Pain score
Time frame: After 15 minutes application time of the anesthetics
The main study parameter is pain, as scored on a VAS from 0-10 (0: no pain; 10: worst imaginable pain).
Pain score
Time frame: After 25 minutes application time of the anesthetics
The main study parameter is pain, as scored on a VAS from 0-10 (0: no pain; 10: worst imaginable pain).
1 secondary outcome
Pain score
Time frame: Directly after pretreatment.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Sep 2017.
- Background: PubMed 26032635Meesters AA, Bakker MM, de Rie MA, Wolkerstorfer A. Fractional CO2 laser assisted delivery of topical anesthetics: A randomized controlled pilot study. Lasers Surg Med. 2016 Feb;48(2):208-11. doi: 10.1002/lsm.22376. Epub 2015 May 29.
- Background: PubMed 24664987Sklar LR, Burnett CT, Waibel JS, Moy RL, Ozog DM. Laser assisted drug delivery: a review of an evolving technology. Lasers Surg Med. 2014 Apr;46(4):249-62. doi: 10.1002/lsm.22227. Epub 2014 Mar 24.
- Background: PubMed 22302761Oni G, Brown SA, Kenkel JM. Can fractional lasers enhance transdermal absorption of topical lidocaine in an in vivo animal model? Lasers Surg Med. 2012 Feb;44(2):168-74. doi: 10.1002/lsm.21130. Epub 2012 Feb 2.
- Background: PubMed 23908302Oni G, Rasko Y, Kenkel J. Topical lidocaine enhanced by laser pretreatment: a safe and effective method of analgesia for facial rejuvenation. Aesthet Surg J. 2013 Aug 1;33(6):854-61. doi: 10.1177/1090820X13496248.
- Background: PubMed 22296284Ong MW, Bashir SJ. Fractional laser resurfacing for acne scars: a review. Br J Dermatol. 2012 Jun;166(6):1160-9. doi: 10.1111/j.1365-2133.2012.10870.x. Epub 2012 May 8.
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Related trials for Local Anesthesia of the Skin
Not yet recruiting
E-MOHS Trial of TENS and Vibration During Local Anesthesia
Pain, Procedural Pain
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.
Albert Wolkerstorfer, MD, PhD principal investigator
Netherlands Institute for Pigment Disorders, Department of Dermatology, Academic Medical Center, University of Amsterdam
Menno A De Rie, MD, PhD study director
Department of Dermatology, Academic Medical Center, University of Amsterdam
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing AHES 5 minutes, AHES 15 minutes and AHES 25 minutes in people with Local Anesthesia of the Skin, run by Netherlands Institute for Pigment Disorders.
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 3 inclusion and 10 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: finished, as of the sponsor's last update on 12 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Pain score (time frame: After 5 minutes application time of the anesthetics). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03279757, which also lists 17 linked publications.
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 12 Sep 2017; AzTrials last refreshed its copy on 8 Nov 2026.