Use of Intense Pulsed Light (IPL) in Indian Skin Types

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Use of Intense Pulsed Light
(IPL) in Indian Skin Types
Presented at the 27th American Society for Laser Medicine and Surgery
(ASLMS) Annual Conference In Grapevine, Texas April 11-15th 2007
Dr Maya Vedamurthy
M.B.B.S; M.D; D.D, Consultant Dermatologist, Chennai, India
AB 76 1st Street Anna Nagar, Chennai, 600040, INDIA E-mail: mayavedamurthy@yahoo.com
Godfrey Town
Laser Protection Adviser, Haywards Heath, UK.
Address for correspondence: godfreytown@csi.com or mayavedamurthy@yahoo.com
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Introduction
Unwanted hair, benign pigmented lesions and acne are major cosmetic problems in Indian skin types. It is usually
assumed that many lasers and IPL devices are not suitable for dark skinned patients. These assumptions fail to recognise
that the contrast between skin and hair (or lesion) colour remains largely constant or even increases with darker skin.
Numerous previous studies have reported the effectiveness of both Q-switched and microsecond pulsed lasers in the
removal of epidermal benign pigmented lesions and acne in light skin types (Fitzpatrick I – III) [1-7]. Other studies have
shown intense pulsed light (IPL) to be successful in the treatment of unwanted body and facial hair in both Caucasian and
East Asian skin types [8-14]. Early studies by Sherwood et al [15] and Anderson et al [16] exposed pigskin to different
wavelengths to establish ideal wavelength for the treatment of pigmented lesions. These studies variously found 504 nm
and 532 nm to achieve ideal pigment clearance thus demonstrating a need for a compromise between a high absorption in
melanin and optimum penetration depth for specific lesion clearance. Other studies have shown efficacy in the use of
Q-switched lasers in Caucasian and Asian skin types including lesions with a significant dermal component [17-20].
Subsequently, other investigators have shown efficacy in the removal of pigmented lesions using IPL wavelengths
concentrated in this range [21-23]. However, relatively few studies have focused on treating darker skin types, particularly
those found typically on the tropical and sub-tropical Indian Sub-Continent. In an unpublished study in 1999 of 170 patients
of skin types III-V, R. Shah MD (Baroda, India) reported a total of 360 ruby laser treatments with a normal incidence of
treatment-related skin reactions with few real side effects, particularly when efficient air-cooling of the skin was used.
This study describes the early results of the incidence of side effects and treatment-related problems in dark Indian skin
types (Fitzpatrick 4 & 5) using a novel constant spectrum IPL source (iPulse, CyDen Ltd., Swansea, UK) and its efficacy in
hair removal and the treatment of benign pigmented lesions and acne.
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Methods
The cases reviewed in this study were selected amongst ordinary patients attending the private dermatology clinic of
Dr Maya Vedmurthy in Chennai. If subjects presented with any of the conditions suitable for IPL, they were offered the
treatment. Whilst the manufacturer’s recommended treatment parameters and application techniques for dark skin types
were used, fixed intervals between treatments were not maintained easily because of poor patient compliance arising out
of lack of familiarity with routine attendance for cosmetic medical treatment.
No Ethics Committee approval was required as the study was conducted in a private dermatology clinic in Chennai. All
subjects had the purpose of the trial explained to them, and each subject gave written informed consent both to participate
in the trial and for the subsequent use of their clinical photography.
Treatment sites & numbers
Standardized patient data collection forms were used to record gender, age, ethenicity, skin type, treatment parameters,
side effects, pain, treatment outcomes and other observations.
The study included a total of 147 subjects with an average age of 31.2 yrs (range, 25-40 years). 100 subjects belonged to
Fitzpatrick to skin type IV and 47 to skin type V.
130 female and 17 male patients with dark Indian skin types were treated up to 7 times for hirsutism and cosmetic hair
removal in other body areas, up to 10 times for mild to moderate inflammatory acne vulgaris and up to 6 times for benign
epidermal pigmentation including freckles, PIH, melasma and other benign pigmented lesions.
Treatment type:
Hair Reduction
Acne
Pigment
No of patients (total 147)
53
35
59
Av. age (yrs)
29.7
28.4
34.3
Av. treatment grading scores
0.9
1.1
0.7
1 treatment
0.2
(n = 23)
0.4
(n = 18)
0.1
(n = 30)
2-4 treatments
1.30
(n = 24)
1.42
(n = 14)
1.29
(n = 25)
5+ treatments
2.32
(n = 6)
3.0
(n = 3)
1.5
(n = 4)
Av. no. treatments
2.4
2.1
2.1
Av. pain level (0% = no pain at all, 100% = worst pain imaginable)
49.1%
44.5%
44.7%
No. patients with normal skin reactions
12 (22.6%)
5 (14.3%)
20 (33.9%)
No. patients with true side effects
3 (5.7%)
0 (0%)
2 (3.4%)
Table 1—Summary of results
Treatment parameters in respect of pulse duration and energy density (fluence) were determined individually according to
manufacturer’s recommendations, precise skin typing and reaction to test patch treatments. In view of the dark skin types
prevalent in South East India, triple sub-pulses were used with total pulse durations in the range of 35-45 ms with intrapulse off-times of 5-10 ms to facilitate epidermal cooling whilst ensuring follicular or pigmentary coagulation. The pulse
fluence used of 10-14 J/cm2 using an 8.9 cm2 skin contact spot size and twin parallel xenon lamp configuration was found
to be sufficient to produce normal erythema, peri-follicular oedema or darkening of epidermal pigmented lesions.
The incidence of side effects and the treatment outcomes were evaluated by direct assessment, a patient questionnaire to
record pain response and the level of patient satisfaction and by expert medical review of patient before/after photographs.
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Intense Pulsed Light Device
An iPulse™ i200 (CyDen Ltd., Swansea, United Kingdom) intense pulsed light device was used for all treatments. This novel
IPL was chosen because of its constant spectral output profile and it was hypothesized that the time-resolved constant
spectrum output between 530 nm and 1200 nm for the entire pulse duration claimed by the manufacturer would ensure
efficient and stable delivery of energy to the dark Indian skin types in the study and reduce the side effects often associated
with conventional, free-discharge IPL devices when used to treat dark skins [24].
Treatment procedure
Pre- and post-treatment photography was used. The treatment area was shaved and cleaned and the area covered with
chilled ultrasound gel. The IPL treatment program and fluence was chosen based on skin condition, skin type and reaction
to initial test patch treatments. After treatment, cooling gel packs were applied to the area. Aloe vera cream was gently
rubbed into the treated area when the treatment session was completed. No other creams or preparations were used
except in cases of melasma where hydroquinone (2%) cream was used as an adjunctive treatment. Those who were
satisfied with results at follow-up or did not wish to continue received no further treatment. Patients who were not satisfied
could receive further treatment sessions with the same protocol as above, until the final assessment point when the patient
and dermatologist felt satisfied with the result, or agreed that no further improvement could be seen.
Figure 1—iPulse i200+
(CyDen Ltd., Swansea, UK) twin-lamp, constant
spectrum IPL system used in the study.
4
Figure 2—(Above) Schematic illustration of the difference in spatial
and temporal profile of a free discharge and partial discharge pulse.
(Below) Time resolved spectral measurements using an OceanOptics™
spectrometer and Spectrasuite counterpart software showing spectral “jitter”
versus constant spectral emission [24].
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Results & Discussion
The groups comprised hair removal: n=53; acne: n=35 and pigmentation: n=59. The overall average fluence used was
11.6, 10.5 and 12.3 J/cm2 respectively.
The study was conducted in Chennai city in Southern India where the normal range of skin types of patients seeking treatment
is Fitzpatrick IV-V and the sunny climate is constantly hot and humid with an average ambient temperature even in airconditioned rooms above 25ºC. These climatic conditions increase treatment-related problems and increase the incidence of
post-treatment side effects aggravated by sun exposure to skin areas exposed to intense pulsed light or laser wavelengths.
It is reasonable to assume that certain pigmented lesions may be diagnosed accurately by an expert dermatologist as
benign without the benefit of histological validation (impossible where the treatment with light therapy is entirely non-invasive
and no tissue is removed during the procedure).
The generally poor response after only one or two treatments confirms the importance of completing a course of IPL
treatments at regular intervals. Patients who failed to attend sufficient treatment sessions, showed reduced effectiveness as
assessed by the expert clinician. Where more treatment sessions were given, in most cases better results were observed.
In common with other anecdotally reported experience with laser and IPL devices in India, a conservative approach is
normally taken to choosing treatment parameters and it is generally found that numbers of treatments needed to achieve
satisfactory results are greater than in countries with lighter skin types and even where treatment energy levels are similar,
more treatments appear to be necessary.
Efficacy
Treatment outcomes were only assessed and recorded at
the end of a treatment or course of treatments when the
patient and/or dermatologist were satisfied that no further
improvement could be achieved, where the patient did not
wish to continue or where the patient simply failed to appear
for further scheduled treatments. The standard descriptions
of efficacy used in this study by the expert clinical assessor
were graded and assessed as follows:
Hair Reduction:
0
1
2
3
=
=
=
=
No reduction (<10%),
Some Reduction (>25%),
Moderate Reduction (>50%),
Good Reduction (>70%).
As expected, where multiple treatments were given the
greatest degree of hair reduction was achieved. In general,
there was little reduction in regrowth of hair follicles after a
single treatment, a moderate reduction only after 3-4
treatments and in two cases of thick, facial hair, a good
reduction after 7 treatments. Table 2 indicates better results in
fewer treatments for cosmetic hair removal versus hirsutism.
Intervals between treatments needed to be 3-4 weeks and the
trial subjects did not always follow this.
There were fewer cases of cosmetic hair removal on body
areas than might be seen in comparable studies in lighter skin
types. This is probably explained by cultural preferences and
traditional Indian garment design.
Figure 3—Hirsutism: Female, age 20 yrs, skin type V, 50% reduction with
regrowth of finer lighter hair. 6 treatments at irregular intervals over 10 months
using a fluence of 11-13 J/cm2, triple sub-pulses: 14 ms on, 7 ms off.
3
Significant
reduction
Cosmetic
Hisuitism
Satisfaction
Grade
Grade
Grade
Grade
2
Moderate
reduction
1
Some
reduction
0
3
4
5
6
7
No. of treatments
Figure 4—Hair Removal: Graph showing patient satisfaction,
with progressively better results with increasing numbers of treatments
in both hirsutism and purely cosmetic hair removal cases
No reduction
1
2
5
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No. treatments
1
2
3
4
5
6
7
0.1
0.4
1.2
1.5
2.5
1.0
3.0
(n = 16)
(n = 7)
(n = 5)
(n = 4)
(n = 2)
(n = 1)
(n = 2)
0.5
1.0
2.0
2.3
-
-
-
(n = 6)
(n = 20)
(n = 3)
(n = 3)
-
-
-
Hirsutism
Cosmetic
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Table 2—Hair removal
Average treatment grading scores with different numbers of treatments for hirsutism and cosmetic facial hair removal.
0 = No reduction (<10%), 1 = Some Reduction (>25%), 2 = Moderate Reduction (>50%), 3 = Good Reduction (>70%).
Acne Improvement:
0
1
2
3
=
=
=
=
No reduction (<10% clearance of acne spots),
Some Reduction (>25%),
Moderate Reduction (>50%),
Significant Reduction (>70%).
The improvement in results with increasing numbers of treatments was best shown in acne improvement grades with some
reduction achieved in only two treatments.
3
Significant
reduction
Satisfaction
2
Moderate
reduction
1
Some
reduction
0
1
No reduction
2
3
4
5
7
No. of treatments
10
Figure 5—Acne improvement: Graph showing patient satisfaction with
some reduction achieved in only two treatments.
No. treatments
Facial acne
Figure 6—Acne: Female, age 20 yrs, skin type V, before and three months
after (5 treatments at 2-3 week intervals using a fluence of 10 J/cm2,
single 50 ms pulse).
1
2
3
4
5
7
10
0.4
1.2
1.7
2.0
3.0
3.0
3.0
(n = 18)
(n = 9)
(n = 3)
(n = 2)
(n = 1)
(n = 1)
(n = 1)
Table 3—Acne
Average treatment grading scores for facial acne. 0 = No reduction (<10% clearance of acne spots), 1 = Some Reduction (>25%),
2 = Moderate Reduction (>50%), 3 = Significant Reduction (>70%)
Pigmented Lesions:
0
1
2
3
4
=
=
=
=
=
No Lightening (<10%),
Some Lightening (>25%),
Moderate Lightening (>50%),
Good Lightening (>70%)
Complete Clearance (>90%).
Clinically assessed improvement (lightening) of pigmented lesions ranged from “no lightening” at all to “complete clearance”.
Where multiple treatments were undertaken the greatest degree of lightening was achieved. With freckles, melasma and
post-inflammatory hyperpigmentation (PIH), multiple treatments were needed to produce satisfactory results.
Café au lait did not respond even after 3 treatments.
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Becker’s Naevus – Single treatments were completely ineffective, multiple treatments on the thigh of one patient were
similarly ineffective and one case showed darkening of the naevus at 4 weeks post treatment. This was probably due to the
deep location of the pigment.
Figure 7—Freckles: Female, age 23 yrs, skin type V, before and one month
after (two treatments at 2 week intervals using a fluence of 13 J/cm2,
triple sub-pulses: 10 ms on, 15 ms off).
Figure 8—Melasma: Female, age 30 yrs, skin type IV, before and seven
weeks after (five treatments at weekly intervals using a fluence of 13 J/cm2,
triple sub-pulses 10 ms on, 20 ms off.)
Figure 9—Melasma: Female age 56 yrs, skin type V, before and after
48 weeks (three treatments at 40 day intervals, 12-14 J/cm2,
triple sub-pulses 14 ms on, 7 ms off).
Figure 10—Melasma Side Effects: Female, age 42 yrs, skin type V, before
and 4 days post treatment showing typical temporary depigmentation
following crusting 13 J/cm2, triple sub-pulses: 14 ms on, 7 ms off.
No. treatments
Becker’s
Freckles
Melasma
Pigment
PIH
Total scores
1
2
3
4
5
6
0.0
-
-
0.0
-
-
(n = 2)
-
-
(n = 1)
-
-
0.3
1.2
2.0
1.5
-
-
(n = 7)
(n = 5)
(n = 1)
(n =2)
-
-
0.1
1.0
1.0
1.0
2.0
-
(n = 7)
(n = 1)
(n = 1)
(n = 1)
(n = 1)
-
0.1
1.0
0.8
2.2
-
0.0
(n = 12)
(n = 4)
(n = 4)
(n = 5)
-
(n = 1)
0.0
-
-
-
2.0
-
(n = 0)
-
-
-
(n = 2)
-
0.1
1.1
1.0
1.7
2.0
0.0
(n = 30)
(n = 10)
(n = 6)
(n = 9)
(n = 3)
(n = 1)
Table 4—Pigmentation
Average treatment grading scores for pigmentation. 0 = No Lightening (<10%), 1 = Some Lightening (>25%),
2 = Moderate Lightening (>50%), 3 = Good Lightening (>70%) 4 = Complete Clearance (>90%).
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3
Significant
reduction
Total scores
PIH
Pigment
Satisfaction
2
Moderate
reduction
Melasma
Freckles
1
Some
reduction
0
No reduction
1
2
3
4
5
6
No. of treatments
Figure 11—Pigmentation: Graph showing patient satisfaction, with some reduction in PIH, pigment,
melasma and freckles after only two treatments and progressively better results with more treatments.
Side Effects & Treatment-related Problems
Side effects and treatment-related problems were assessed to range from “none” to “severe superficial burns” across all
treatment types included in the study. Treatment-related problems are considered to be normal in IPL treatments and in this
study included skin reactions following treatment up to and including severe erythema in hair removal, mild to normal
erythema in acne cases and darkening of pigmented areas or temporary crusting. In the case of pigmentation treatments,
temporary crusting of epidermal lesions, which sloughs off within 7-10 days during normal washing was distinguished from
transient hyperpigmentation that lasted several weeks to several months and was considered a true side effect.
T. Alster reported a significant incidence of side effects [25] in darker skin phototypes following laser treatment and
recommended prophylactic application of SPF30+ sun screen initiated at least three to four months before laser surgery to
avoid post-inflammatory hyperpigmentation. No such precautions were taken in this study when using IPL therapy.
Normal side effects
No. Patients (%) No. incidents
Av. pain score
Areas
Side effect(s)
Acne
5 (14.3)
5
39.8
Face
Mild erythema
Hair removal
12 (28.8)
17
45.5
Face
Mild erythema
Pigment
20 (33.9)
21
46.6
Face, thigh (1), chest (1)
Mild erythema
0 (0)
0
n/a
n/a
n/a
Hair removal
3 (5.7)
5
47.5
Face, legs (1)
Burns (1), erythema
Pigment
2 (3.7)
3
48.7
Face
Burns (1), erythema (2)
True side effects
Acne
Table 5—Side effects
The standard descriptions of side effects used in this study by the expert clinical assessor were graded as follows:
Hair Removal:
0
1
2
3
4
5
8
=
=
=
=
=
=
None,
Mild Erythema,
Erythema (e.g. Perifollicular Oedema),
Severe Erythema,
Crusting (eg. including transient hyperpigmentation),
Severe Superficial Burns (eg. including hypopigmentation).
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Acne:
0
1
2
3
=
=
=
=
None,
Mild to Normal Erythema,
Hyperpigmentation,
Severe Superficial Burns.
All acne patients showed a reduction in the number of inflamed lesions with no side effects. The reduction of acne spots
observed was similar to results reported in the literature for lighter skin types treated with IPL.
Pigment:
0
1
2
3
4
=
=
=
=
=
None,
Mild to Normal Erythema / darkening of pigmented lesion / crusting,
Hyperpigmentation,
Severe Superficial Burns,
Hypopigmentation.
Normal erythema was only seen in about one third of patients suggesting an over-cautious approach. Side effects were
seen with increased fluence. Two cases of post hair removal treatment burns were reported. The consequential
hyperpigmentation resolved in both of these cases within 3 months (See figures 7-9).
Pain
Pain experienced by the patients during all of the treatments was graded using a blank visual analogue scale (0 = no pain
at all and 10 = worst pain imaginable). Average pain scores for hair removal, acne and pigmentation were 4.5, 4.7 and 4.2
respectively. Most subjects found the level of discomfort easily tolerated and no subjects felt the pain was unbearable as no
scores were recorded above 7.0 (See figure 10).
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Conclusions
When a sufficient number of treatments were performed, the iPulse constant spectrum IPL was found to be effective in this
preliminary study in the treatment of benign pigmented lesions, acne and in the long-term delay of hair regrowth in hirsutism.
Normal treatment related problems including patient assessed pain response and side effects using the iPulse IPL with its
constant spectral output, large 8.9 cm2 spot size and relatively low fluence characteristics, were found to be comparable
in dark Indian skin to those reported in the literature in lighter skin types with conventional IPL devices. Early indications
of efficacy in the treatment of hirsutism, pigmentation and acne were broadly similar to lasers and other IPL systems in
lighter skin types.
Both the follow-up period and the number of lesions included in the present study may not be sufficient to fully evaluate
the potentials of this treatment modality as well as the true incidence of recurrence of the original condition. Therefore, the
results obtained should be confirmed in larger studies.
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