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66 medinfo.bg Issue 07/2014, Year XIV 07 JULY 2014 P atients frequently seek treatment of cutaneous vascular lesions for both medical and cosmetic reasons. Tra- ditional options for treating these problems are often painful, time-consuming or not suitable for removal of very fine vessels. Advances in the use of lasers and light sources enable physicians to effectively treat the vascular lesions that were previ- ously untreatable [1] . Clinical background First laser treatments of cutaneous vascu- lar lesions began with Dr. Leon Goldman in 1963 at the Children‘s Hospital Research Foundation in Cincinnati, Ohio. The next major advance was the development of the flash lamp pumped pulse dye laser (PDL) in the mid-1980s to treat PWS (port wine stain). This laser was developed based on the theory of selective photothermoly- sis described by Anderson and Parrish [2] . According to this theory a specific laser wavelength and energy is delivered to elim- inate gradually a specific target – oxygen- ated haemoglobin in red blood cells in the blood vessel. The latest advance was the development of intense pulsed light (IPL) devices in 1993. The IPL technology is the single most Background and objective: Intense pulsed light (IPL) therapy is a non-invasive and non-ablative treatment that improves the appearance of many skin problems. The aim of this study was to assess the efficacy and safety of an IPL device in the treatment of cutaneous vascular lesions. Methods: The facial vascular lesions (telangiectasia) of 15 female subjects were treated with an IPL device (Exilite, BTL Industries Ltd.). All patients received 4 consecutive sessions at 2-week intervals. Patients‘ satisfaction with clinical outcome was obtained as primary outcome measure through a patients five-point scale questionnaire (1: Not at all satisfied to 5: Very satisfied) and a patients discomfort evaluation was obtained as secondary outcome measure using the five-point scale questionnaire (1: No pain to 5: Worst pain). To document therapy results, photographs of the treated area were taken before the first and third treatment and 30 days after the last treatment using special camera (ANTERA 3D ® ) with software statistical analysis. Results: Eighty-six percent of patients were “very satisfied“ with achieved results; 7% were “somehow satisfied“ and the remaining 7% were “neither satisfied nor dissatisfied“. Patients generally tolerated the therapy well. The most common reported pain level was 3 (Moderate pain). There were no adverse events observed during the trial. Conclusion: The study showed very high satisfaction level with clinical outcomes of the IPL device in the treatment of cutaneous vascular lesions while the pain level remained in tolerable levels. This makes this kind of therapy a reasonable clinical option for the treatment of cutaneous vascular lesions. Safety and Efficacy Evaluation of the Intense Pulsed Light Device in Treatment of Cutaneous Vascular Lesions Dr. Katya Paskova, Dr. Dessislava Lekova Derma Vita Aesthetic Medicine Clinic, Sofia, Bulgaria

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Page 1: Safety and Effi cacy Evaluation of the Intense Pulsed ...btlquebec.com/...Cutaneous_Vascular_Lesions_en100.pdf · cutaneous vascular lesions for both medical and cosmetic reasons

66

medinfo.bg

Issue 07/2014, Year XIV

07JULY

2 0 1 4

Patients frequently seek treatment of

cutaneous vascular lesions for both

medical and cosmetic reasons. Tra-

ditional options for treating these problems

are often painful, time-consuming or not

suitable for removal of very fine vessels.

Advances in the use of lasers and light

sources enable physicians to effectively

treat the vascular lesions that were previ-

ously untreatable[1].

Clinical background

First laser treatments of cutaneous vascu-

lar lesions began with Dr. Leon Goldman in

1963 at the Children‘s Hospital Research

Foundation in Cincinnati, Ohio. The next

major advance was the development of the

flash lamp pumped pulse dye laser (PDL)

in the mid-1980s to treat PWS (port wine

stain). This laser was developed based

on the theory of selective photothermoly-

sis described by Anderson and Parrish[2].

According to this theory a specific laser

wavelength and energy is delivered to elim-

inate gradually a specific target – oxygen-

ated haemoglobin in red blood cells in the

blood vessel.

The latest advance was the development of

intense pulsed light (IPL) devices in 1993.

The IPL technology is the single most

Background and objective: Intense pulsed light (IPL) therapy is a non-invasive and non-ablative treatment that improves the

appearance of many skin problems. The aim of this study was to assess the efficacy and safety of an IPL device in the treatment of

cutaneous vascular lesions.

Methods: The facial vascular lesions (telangiectasia) of 15 female subjects were treated with an IPL device (Exilite, BTL Industries

Ltd.). All patients received 4 consecutive sessions at 2-week intervals. Patients‘ satisfaction with clinical outcome was obtained as

primary outcome measure through a patients five-point scale questionnaire (1: Not at all satisfied to 5: Very satisfied) and a patients

discomfort evaluation was obtained as secondary outcome measure using the five-point scale questionnaire (1: No pain to 5: Worst

pain). To document therapy results, photographs of the treated area were taken before the first and third treatment and 30 days after

the last treatment using special camera (ANTERA 3D®) with software statistical analysis.

Results: Eighty-six percent of patients were “very satisfied“ with achieved results; 7% were “somehow satisfied“ and the remaining

7% were “neither satisfied nor dissatisfied“. Patients generally tolerated the therapy well. The most common reported pain level was 3

(Moderate pain). There were no adverse events observed during the trial.

Conclusion: The study showed very high satisfaction level with clinical outcomes of the IPL device in the treatment of cutaneous

vascular lesions while the pain level remained in tolerable levels. This makes this kind of therapy a reasonable clinical option for the

treatment of cutaneous vascular lesions.

Safety and Effi cacy Evaluation of the Intense Pulsed Light Device in Treatment of Cutaneous Vascular Lesions

Dr. Katya Paskova, Dr. Dessislava

Lekova

Derma Vita Aesthetic Medicine Clinic, Sofia,

Bulgaria

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67Medinfo

DERMATOLOGY

popular technology for the treatment of vascu-

lar lesions world-wide[3].

IPL systems differ from lasers in that they

deliver many wavelengths (or colours)

in each pulse of light instead of just one

wavelength. By determining the appro-

priate wavelength, pulse duration, and

fluence, physicians can selectively target

haemoglobin within blood vessels without

damaging the surrounding tissue. The IPL

therapy is a non-ablative technique, which

targets the lower skin layers (dermis) with

minimal effect on the epidermis.

Intense pulsed light devices emitting a con-

tinuous light spectrum with wavelengths

between about 400 and 1200 nm are in-

tended for different applications. This study

evaluates the efficacy and safety of an IPL

device in the treatment of cutaneous vas-

cular lesions.

Materials and

methods

Subjects

Fifteen female subjects were enrolled in

the study. Patients‘ skin types were cate-

gorized according to the Fitzpatrick skin

type scale (I-VI): 13 subjects had skin type

III and two skin type II. Subjects with other

skin types were not enrolled in the study.

The age of patients varied from 26 to 45

years (average age 34.25±6.76 years). The

patients were treated for telangiectasia

(one of the most common type of vascular

lession) and for overall improvement in skin

appearance.

Study design

The main objective of the study was to eval-

uate the efficacy and safety of the IPL de-

vice in the treatment of cutaneous vascular

lesions. Following the initial screening, dur-

ing which demographic data, medical his-

tory and inclusion/exclusion criteria were

reviewed, all suitable patients received 4

consecutive sessions at 2-week intervals,

using various treatment parameters. Sub-

jects‘ satisfaction level was obtained as the

primary outcome measure. The secondary

outcome measure was patients‘ discomfort

level. The following scales were used:

Subjects‘ discomfort 5-point evaluation

was reported after each session.

1: No pain

2: Mild pain

3: Moderate pain

4: Severe pain

5: Worst pain

Subject‘s satisfaction 5-point scale was

reported 30 days after the last treatment.

1: Not at all satisfied

2: Not very satisfied

3: Neither satisfied nor disatisfied

4: Somewhat satisfied

5: Very satisfied

Before and after photographs were taken

for documentation purposes before the

first and third treatment, and 30 days after

the last treatment. The photographs were

obtained with special camera (ANTERA

3D®) with software statistical analysis.

The device therapeutic parameters were

set according to the manufacturer‘s recom-

mended settings.

It is prudent to start with lower fluence, per-

form test spots, and examine the skin for

FIGURE 1:

Patients‘ satisfaction evaluation on 5-point scale obtained 30 days after the last treatment

FIGURE 2:

discomfort evaluation on 5-point scale obtained after each treatment (total of 60 treatments)

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68

medinfo.bg

Issue 07/2014, Year XIV

07JULY

2 0 1 4

the immediate desired clinical end point.

Cooling parameters varied in the range of

20-40%.

Results

Fifteen female subjects completed the

treatment regimen of 4 procedures and

a follow up after 30 days. Clinical photo-

graphs showed overall improvement in vas-

cular lesions of all patients.

The evaluation of patients‘ satisfaction

level resulted in an average value of 4.8

or, 86% of patients were “very satisfied”

with achieved results, 7% of patients were

“somewhat satisfied” and the remaining

7% were “neither satisfied nor disatisfied”.

There was no “not very satisfied” or “not at

all satisfied” patient‘s response (Figure 1).

Photographs taken before the first and

third treatment and 30 days after the last

treatment (Figure 3) showed decrease in

haemoglobin variance. All pictures were

taken with special camera ANTERA 3D®.

No adverse events occurred during the

study. Patients generally tolerated this ther-

apy well, average reported subject discom-

fort, based on the 5-point scale was 2.93,

with 53% of patients describing the pain

during the treatment as moderate. The dis-

comfort was transient and no anaesthesia

was needed (Figure 2).

Conclusion

The IPL device provides a highly versatile,

effective and safe treatment of cutaneous

vascular lesions. The therapy produced

good to excellent reduction in telangiecta-

sia and improved overall skin appearance.

Minimal discomfort and high patients‘ satis-

faction level was achieved.

references1. Tomi L. Wall, Current Concepts: Laser Treatment of Adult Vascular Lesions.

Semin Plast Surg. 2007 Aug;21(3):147-58.

2. Anderson RR, Parrish JA, Selective photothermolysis: precise microsurgery by

selective absorption of pulsed radiation. Science.1983 Apr 29; 220(4596):524-7.

3. Mitchel P. Goldman, Intense Pulsed Light Systems.Laser Treatment of Cuta neous

Vascular Lesion.

FIGURE 3

a1) Patient 1 before treatment

b1) Patient 1: before 3rd treatment

c1) Patient 1: 30 days after the last treatment

a2) Patient 2: before treatment

b2) Patient 2: before 3rd treatment

c2) Patient 2: 30 days after the last treatment

d1) Variance level showing improvements in haemoglobin uniformity after each treatment – Patient 1

d2) Variance level showing improvements in haemoglobin uniformity after each treatment – Patient 2