Download Solar Lentigines Treatment Guidelines

OPS600
Solar Lentigines
Treatment Guidelines
For use with the OPS600 Pulsed Light Handpiece with a wavelength range of 600 to 850 nm.
Appropriate operator safety eyewear for this device, provided by Cutera, senses the light pulse and
blocks out incoming light. A small amount of light at the beginning of the pulse will be visible.
This eyewear is not for use with the 1064 nm laser handpiece.
The patient should be given the solid, light blocking eyewear also provided by Cutera. Observers of
the procedure may wear the green tinted eyewear provided by Cutera.
© November 2006, D0136 Rev. E
Cutera • 3240 Bayshore Boulevard • Brisbane • California • 94005
PH: 415.657.5500 • www.cutera.com
OPS600 Treatment Guidelines
The following guidelines are based on physician feedback from solar lentigo treatments with the OPS600
Pulsed Light Handpiece on patients with Fitzpatrick skin types I–IV. Treatment of patients with skin type V
should be performed with extra caution at lower fluences. Treatment of patients with skin type VI using the
OPS600 Pulsed Light Handpiece is not recommended. Additional treatment information is discussed in the
Clinical Presentations CD included with the system.
The OPS600 should only be operated by qualified practitioners who have received appropriate training
and have thoroughly read the operator manual. Protective eyewear must be worn by all people in the
treatment room.
Consult the Operator Manual for additional information, including contraindications and possible adverse effects.
PRE-OPERATIVE CONSIDERATIONS:
•
Conduct a patient consultation complete with medical history prior to treatment.
•
Patients should not be treated if they have had significant sun exposure, or artificial (light based or
spray-on) tanning, in the 4 weeks prior to treatment.
•
Clean the skin, including removal of all make-up and other skin care products. Any creams or
products left on the skin can interact with the light and increase the risk of unwanted side effects.
•
Shave any hair in the area to be treated.
•
Pre-operative photographs should be taken with consistent technique (patient positioning, camera
settings, and room lighting) prior to the initial treatment for general reference. Printed preoperative photos can also be used to compare and duplicate the same patient position when taking
follow-up photos.
•
Pigmented lesions should be evaluated for potential skin cancer warning signs prior to treatment.
If these are present, the lesion should not be treated unless diagnosed as benign.
•
These treatments can be tolerated without anesthesia. Topical anesthesia can be used if desired. It
must be completely removed prior to treatment. CAUTION: Toxicity may result with overuse of
topical anesthesia. Consult the manufacturer’s labeling.
•
When treating near the mouth, rolled-up gauze can be placed between the lips and teeth to protect
the teeth from discomfort.
•
Although this device has not been optimized for hair removal, patients should be advised that hair
removal may occur as a result of these treatments.
•
Do not treat over areas with tattoos.
•
Extreme caution should be used when treating near the eye, taking care to avoid ocular damage
from the light. Patient eye protection appropriate for the given treatment should be used. The light
should always be pointed away from the eye and only applied to the skin outside of the orbital rim.
Skin at the edge of the orbital rim can be treated by pulling it away from the eye while
simultaneously holding the goggles in place, so treatment is kept outside of the orbital rim.
© November 2006, D0136 Rev. E OPS600 Treatment Guidelines
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OPS600 TREATMENT PARAMETERS:
Treatment of a test area should be performed and observed for the desired response and signs of unwanted
side effects. Settings for full treatment should be based on test area results. A waiting period of 20 to 30
minutes is recommended for most patients when treating lentigines. Darker skin types may require 24 to 48
hours to develop.
SKIN TYPE
FLUENCE
I-III
8 – 18 J/cm2
IV and III with actinic bronzing*
6 – 14 J/cm2
* Actinic bronzing is chronic “tan-like” pigmentation damage resulting from long-term sun exposure. This is
different from recent sun exposure, which should not be treated.
Specific parameters are provided as a guide only. Select parameters depending on color and density of
lentigines, hair density, vascularity, and actinic bronzing. Observe light-tissue interaction and clinical
endpoints to determine appropriate settings. Patients with skin type IV should be treated with caution. No
recommended parameters are available for skin type V patients. Treatment of patients with skin types VI is
not recommended.
•
Treatment is not recommended for areas of recent sun exposure or tanning.
•
The fluence setting should be selected to provide the desired treatment without effecting the
pigmentation of background skin.
•
Use lower fluences for darker targets or over bony areas.
•
The potential for overtreatment is greatest with skin type IV and patients with the pigmentary
effects of long-term tanning (actinic bronzing). Begin with low settings for the initial test
treatment.
•
Fluence settings should not be based on settings used with other pulsed light devices.
© November 2006, D0136 Rev. E OPS600 Treatment Guidelines
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RECOMMENDED TECHNIQUE:
•
The light output of the OPS600 handpiece is emitted through a clear window in a 10 mm by 30
mm area. For best results, ensure that this entire area is in contact with the skin prior to activating
the light pulse.
•
Adjacent to the clear window is an area with a white background. This area is used to maintain the
temperature of the window and does not treat.
•
Place the light-emitting window in contact with the area to be treated. No gel is required.
•
Activate the light pulse.
•
Place the window over the next treatment area and treat in the same manner.
•
If treating an area with closely spaced lentigines, place treatment pulses adjacent to one another so
that there is no more than 1 mm overlap between pulses.
•
The desired response for lentigines is some darkening of the treated lentigines, and possibly mild
erythema. If a large portion of the treated area darkens or develops significant erythema, the
fluence should be reduced. This effect is often delayed.
•
Always observe the epidermis during the treatment, watching for signs of damage (epidermal
separation or gray coloration). If damage is seen, stop the treatment, cool the skin, and reduce the
fluence before continuing.
•
Do not “double pulse” or retreat an area within a single visit.
•
Ensure that the window remains clean during the treatment. This is especially important when
treating over areas with hair.
POST-OPERATIVE CARE:
•
Ice, chilled gel, or hydro-gel pads may be applied post-treatment as needed for patient comfort.
The treatment window can also be used as an effective post-cooling device.
•
Treated lentigines usually darken after treatment, and crusting begins to form within a few days.
This crusting usually resolves in 1 to 3 weeks. It should be allowed to naturally flake off for best
results.
•
The recommended treatment interval is 4 weeks or longer, depending on the rate of clearance.
•
Localized erythema may also be present and typically resolves within 24 to 48 hours. If prolonged
erythema occurs, future treatments should be performed at a lower fluence.
•
If a wound develops an antibiotic ointment may be recommended.
•
Patients should avoid artificial tanning, or sun exposure without sun protection, between
treatments.
© November 2006, D0136 Rev. E OPS600 Treatment Guidelines
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