A Phase 4 interventional study of AFXL and AHES in Cicatrix, sponsored by Netherlands Institute for Pigment Disorders. Terminated at 1 site in Netherlands. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-03-13.
Sponsored by Netherlands Institute for Pigment Disorders · Phase 4, Interventional, and Treatment
The purpose of this study is to assess the efficacy of skin anesthesia using fractional laser assisted delivery of articaine hydrochloride 40 mg/ml and epinephrine 10 µg/ml solution (AHES) compared to standard anesthesia with topical eutectic mixture of lidocaine 25 mg/g and prilocaine 25 mg/g cream (EMLA cream) prior to ablative fractional laser treatment of acne scars and traumatic scars.
Rationale: In dermatology, many minor surgical and laser procedures are carried out under local anesthesia of the skin. Anesthesia using topical formulations is time consuming, as the anesthetic has to be applied at least one hour before treatment, and is often only partially effective. On the other hand infiltration anesthesia is often associated with discomfort and is not tolerated by patients who are for example needle phobic. In the past years, Haedersdal and colleagues have shown that the penetration of various topically applied substances, including photosensitizers, into the skin can be enhanced and accelerated by pretreatment of the skin with a fractional laser, creating a pattern of microscopic ablation craters.1 This improvement in drug penetration is regardless of ablation crater depth.2 There is limited evidence that transepidermal lidocaine absorption can be increased by fractional laser pretreatment.3, 4 These findings might suggest that local anesthesia of the skin may be achieved by applying an anesthetic topically on a skin surface pretreated with a fractional laser. The investigators of the present study hypothesize that fractional laser assisted delivery of topical anesthetics might give a faster and better anesthetic effect, than treatment with the standard treatment of topical anesthesia.
Objective: The objective of this study is to assess the efficacy of skin anesthesia using fractional laser assisted delivery of articaine hydrochloride 40 mg/ml and epinephrine 10 µg/ml solution (AHES) compared to standard anesthesia with topical eutectic mixture of lidocaine 25 mg/g and prilocaine 25 mg/g cream (EMLA cream).
Study design: Prospective, open label, randomized controlled, within subject, study.
Study population: patients >18 years, who give written informed consent, visiting the institute for fractional carbon dioxide laser treatment for acne scars or traumatic scars.
Intervention (if applicable): In each patient, the lesional area will be divided into two comparable regions during the visit prior to the (next) fractional laser treatment. These regions will then be randomly allocated to either standard anesthesia with EMLA cream (control region; region I) or ablative fractional laser (AFXL) assisted delivery of AHES (intervention region; region II). Patients will be asked to apply EMLA cream at region I under occlusion two hours prior to the laser treatment. Fifteen minutes before the therapeutic laser treatment of the scars, the skin of region II will be pretreated with the fractional carbon dioxide laser (15% density, 2.5 mJ/microbeam). Directly following fractional laser pretreatment, AHES will be topically applied under occlusion at region II for 15 minutes. Subsequently treatment of both regions will be performed with the same fractional carbon dioxide laser at the settings used in routine clinical practice. Directly after this therapeutic laser treatment, patients will be asked to indicate pain per test region on a visual analogue scale (VAS) from 0-10 (0: no pain; 10: worst imaginable pain).
317 studies on the registry are indexed under Cicatrix; 54 are open to participants now.
This study's enrollment of 3 is below the median of 40 across 260 interventional studies indexed under Cicatrix.
Browse Cicatrix studies →Netherlands Institute for Pigment Disorders is the lead sponsor of 9 studies on the registry; none are open to participants now.
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Exclusion Criteria:
Standard topical anesthesia using eutectic mixture of lidocaine 25 mg/g and prilocaine 25 mg/g cream (EMLA cream) applied two hours before treatment.
Drug: EMLA cream
Anesthesia using articaine hydrochloride 40 mg/ml and epinephrine 10 µg/ml solution (AHES) applied on ablative fractional laser (AFXL) pretreated skin 15 minutes prior to the treatment.
Device: AFXL · Drug: AHES
Pretreatment at 2.5 mJ/microbeam and 15% density.
Also known as: Fractional carbon dioxide laser, Ablative fractional laser, Fractional CO2 laser, UltraPulse®, DeepFx handpiece; Lumenis Inc.
Topical application on AFXL pretreated skin 15 minutes prior to the treatment.
Also known as: Ultracain DS Forte, articaine hydrochloride 40 mg/ml + epinephrine 10 μg/ml
Topical application 2 hours prior to the treatment.
Also known as: lidocaine 25 mg/g + prilocaine 25 mg/g cream
Pain, as scored on a VAS from 0-10 (0: no pain; 10: worst imaginable pain) at each of both regions.
Time frame: < 1 minute after AFXL treatment
The record gives a start of Jun 2015, a primary completion of Jan 2016 and a completion of Jan 2016. It does not say whether these dates are actual or estimated.
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This study is terminated, as verified in Mar 2019. You cannot join it, but the record below documents what was studied.
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Netherlands Institute for Pigment Disorders