demonstrated 50%–100% improvement in benign pigmented lesions (ie, solar lentigines and ephelides) after 1–3 treatment sessions. For a typical vessel 0.1–0.3 mm in diameter, the TRT is approximately 4–10 ms, respectively. The epidermis is approximately 0.1 mm thick with a TRT of approximately 4ms. Therefore, vessels greater than 0.3 mm in diameter cool more slowly than epidermal cells with a single pulse. Multiple sequential pulsing (MSP), a feature of the Stellar M22 Universal IPL (Lumenis, Yokneam, Israel), allows for successive heating of targeted chromophores with adequate cooling time delays for the epidermis and surrounding structures effectively treating larger targets safely. MSP should be spaced 10 ms or greater to allow for epidermal cooling. Generally, lighter skin types can be treated with a 10ms delay between pulses, while darker skin types and skin types with hyperreactive melanocytes (eg, Asian skin) can be treated with a 30–40 ms pulse delay.
Clinical endpoints when treating conditions such as rosacea, melasma, poikiloderma of Civatte and benign pigmented lesions (ie, lentigines and ephelides) is mild to moderate erythema with some mild graying of the pigmented lesions. Vasospasm or coagulation of the vessel is the endpoint when treating facial, truncal and leg telangiectasias. Performing a test spot and observing tissue response after a few minutes is advised before proceeding further with treatment. If unsure of the cutaneous response or when treating lesions with a dense amount of chromophore, a test spot starting at low fluence with double or triple pulsing may be performed with evaluation at 1–2 weeks.
In this clinical study, we report the safety, efficacy and tolerability of the newest generation (6th generation) of an IPL system with MSP (Stellar M22 Universal IPL, Lumenis, Yokneam, Israel), using several of its filters with a variety of parameters (ie, fluence, pulse duration, number of pulses).
Clinical endpoints when treating conditions such as rosacea, melasma, poikiloderma of Civatte and benign pigmented lesions (ie, lentigines and ephelides) is mild to moderate erythema with some mild graying of the pigmented lesions. Vasospasm or coagulation of the vessel is the endpoint when treating facial, truncal and leg telangiectasias. Performing a test spot and observing tissue response after a few minutes is advised before proceeding further with treatment. If unsure of the cutaneous response or when treating lesions with a dense amount of chromophore, a test spot starting at low fluence with double or triple pulsing may be performed with evaluation at 1–2 weeks.
In this clinical study, we report the safety, efficacy and tolerability of the newest generation (6th generation) of an IPL system with MSP (Stellar M22 Universal IPL, Lumenis, Yokneam, Israel), using several of its filters with a variety of parameters (ie, fluence, pulse duration, number of pulses).
MATERIALS AND METHODS
This was a prospective study testing several filters (515 nm; 560 nm; 590 nm and 530–650; 900–1200 nm vascular filter), fluences, pulse durations and pulse numbers (ie, multiple sequence pulsing or MSP) with the newest generation IPL system (Stellar M22 Universal IPL, Lumenis, Yokneam, Israel) on a single subject.
Test Device
The IPL system emits a spectrum of light (400–1200 nm) with 9 different filters. These include changeable filters for “Acne†(400–600 nm and 800–1200 nm) and “Vascular†(530–650 nm and 900–1200 nm) lesions, as well as 515 nm; 560 nm; 590 nm; 615 nm; 640 nm; 695 nm; 755 nm filters using a single handpiece. There are 3 available continuous contact cooling sapphire crystals (8x15 mm, 15x35 mm, and 6 mm round) capable of delivering a max fluences of 35 J/cm2, 35 J/cm2 and 56 J/cm2, respectively. Multiple sequential pulsing (MSP) allows the fluence chosen to be delivered within 1–3 pulses and pulse durations ranging from 3–20 ms in total.
Treatment
The treatment area was cleansed with 4% chlorhexidine solution and then baseline standardized digital photography was captured (Canon Rebel SL2, Canon USA Inc., Melville NY). No topical numbing was used so as to not interfere with target chromophores (ie, melanin vs. hemoglobin). A 4x3 grid was marked out on a 65-year-old male, Fitzpatrick skin type III (Figure 1). Four (4) filters (515 nm, 560 nm, 590 nm, 530–650 nm, and 900–1200 nm vascular filter) were marked out in columns across the back and 3 pulse durations (4 ms, 6 ms and 10 ms) were marked out in rows inferiorly. The one exception was a 6.5 ms triple pulse in the most inferior micro row due to the max pulse duration of the MSP technology limitation of 20 ms in total. Each micro column increased in fluence across and each micro-row increased in number of pulses (ie, 1–3) inferiorly (Table 1). The IPL device was technically limited to lower fluence levels for single pulse mode at 4.0 ms pulse duration for all of the investigated filters. Similarly, it was limited to lower fluence levels for single pulse mode at 6.0 ms pulse duration for the vascular filter. Adverse events were monitored, and standardized digital photography was captured immediately after treatment, 4-hours post treatment, 24 hours post-treatment, 1-week post-treatment, 2-weeks posttreatment, and 4-weeks post-treatment.
Test Device
The IPL system emits a spectrum of light (400–1200 nm) with 9 different filters. These include changeable filters for “Acne†(400–600 nm and 800–1200 nm) and “Vascular†(530–650 nm and 900–1200 nm) lesions, as well as 515 nm; 560 nm; 590 nm; 615 nm; 640 nm; 695 nm; 755 nm filters using a single handpiece. There are 3 available continuous contact cooling sapphire crystals (8x15 mm, 15x35 mm, and 6 mm round) capable of delivering a max fluences of 35 J/cm2, 35 J/cm2 and 56 J/cm2, respectively. Multiple sequential pulsing (MSP) allows the fluence chosen to be delivered within 1–3 pulses and pulse durations ranging from 3–20 ms in total.
Treatment
The treatment area was cleansed with 4% chlorhexidine solution and then baseline standardized digital photography was captured (Canon Rebel SL2, Canon USA Inc., Melville NY). No topical numbing was used so as to not interfere with target chromophores (ie, melanin vs. hemoglobin). A 4x3 grid was marked out on a 65-year-old male, Fitzpatrick skin type III (Figure 1). Four (4) filters (515 nm, 560 nm, 590 nm, 530–650 nm, and 900–1200 nm vascular filter) were marked out in columns across the back and 3 pulse durations (4 ms, 6 ms and 10 ms) were marked out in rows inferiorly. The one exception was a 6.5 ms triple pulse in the most inferior micro row due to the max pulse duration of the MSP technology limitation of 20 ms in total. Each micro column increased in fluence across and each micro-row increased in number of pulses (ie, 1–3) inferiorly (Table 1). The IPL device was technically limited to lower fluence levels for single pulse mode at 4.0 ms pulse duration for all of the investigated filters. Similarly, it was limited to lower fluence levels for single pulse mode at 6.0 ms pulse duration for the vascular filter. Adverse events were monitored, and standardized digital photography was captured immediately after treatment, 4-hours post treatment, 24 hours post-treatment, 1-week post-treatment, 2-weeks posttreatment, and 4-weeks post-treatment.
RESULTS
Observational Analysis
Standardized digital photography was obtained at baseline (Figure 1A), immediately post-procedure, 4 hours postprocedure, 24 hours post-procedure, 1-week post-procedure, 2-weeks post-procedure, and 4-weeks post-procedure.
The immediate post-procedure erythema response was more pronounced with increasing fluence, decreasing wavelength, fewer pulses, and shorter pulse duration. The exception was the 515 nm filter with regard to pulse duration, which was observed to have a more pronounced response with longer pulse durations. The vascular filter had a relatively more robust erythema response compared to the 590 nm filter, which was comparable to the 560 nm filter. More robust erythema responses were observed with subtle darkening of lentigos (Figure 1B).
The 4-hour post-procedure photos demonstrated the same overall trend. However, the erythema response was overall more pronounced and deeper red in color. Darkening of the lentigos were also present in the treated squares with exuberant erythema response (Figure 1C).
Standardized digital photography was obtained at baseline (Figure 1A), immediately post-procedure, 4 hours postprocedure, 24 hours post-procedure, 1-week post-procedure, 2-weeks post-procedure, and 4-weeks post-procedure.
The immediate post-procedure erythema response was more pronounced with increasing fluence, decreasing wavelength, fewer pulses, and shorter pulse duration. The exception was the 515 nm filter with regard to pulse duration, which was observed to have a more pronounced response with longer pulse durations. The vascular filter had a relatively more robust erythema response compared to the 590 nm filter, which was comparable to the 560 nm filter. More robust erythema responses were observed with subtle darkening of lentigos (Figure 1B).
The 4-hour post-procedure photos demonstrated the same overall trend. However, the erythema response was overall more pronounced and deeper red in color. Darkening of the lentigos were also present in the treated squares with exuberant erythema response (Figure 1C).
