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707
COPYRIGHT © 2006 JOURNAL OF DRUGS IN DERMATOLOGY

MONOPOLAR RADIOFREQUENCY FACIAL TIGHTENING:

A RETROSPECTIVE ANALYSIS OF EFFICACY AND SAFETY
IN OVER 600 TREATMENTS
Robert A. Weiss MD,a,b Margaret A. Weiss MD,a,b Girish Munavalli MD MHS,a,b,c Karen L. Beasley MDb,c
a. Department of Dermatology, Johns Hopkins University School of Medicine, Baltimore, MD
b. Maryland Laser, Skin and Vein Institute, Hunt Valley, MD
c. Division of Dermatology, University of Maryland School of Medicine, Baltimore, MD

Abstract
Background and Objectives: Monopolar radiofrequency skin heating coupled with cryogen cooling of facial skin for skin
tightening has been utilized on over 10,000 patients since 2002. In order to establish the actual rate and degree of side effects
in our clinical experience, a retrospective chart review was performed.
Study Design: Charts and clinical images of over 600 consecutive patient treatments between May 2002 and June 2006 using
a monopolar radiofrequency device (Thermacool®, Thermage, Haywood, CA) for skin tightening at the Maryland Laser, Skin
and Vein Institute were retrospectively reviewed. The primary presentation for treatment was skin laxity of the lower face.
Treatment was delivered with a 1-cm2 standard tip at fluences of 81 to 124 J/cm2 (level of 12.5 to 15), a 1-cm2 “fast” tip at
fluences of 62 to 109 J/cm2 (level of 72.0 to 76.0), a 1.5-cm2 “big fast” tip at fluences of 75 to 130 J/cm2 (level of 61.5 to 65),
and a 3-cm2 “bigger” tip at equivalent fluences as each became available. As treatment algorithms evolved over 4 years,
the algorithm of multiple passes at lower fluence associated with better clinical outcomes and greater patient acceptance has
been adopted.
Results: The most common immediate and expected clinical effects were erythema and edema lasting less than 24 hours,
although 6 patients reported edema lasting for up to 1 week. There were no permanent side effects. In total, 2.7% of treat-
ments resulted in temporary side effects, the most significant of which was a slight depression on the cheek (n = 1), which

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completely resolved within 3.5 months. Other side effects included localized areas of acneiform subcutaneous erythematous
papules (n = 4) and a linear superficial crust (n = 1) with the original tip, all of which resolved within 1 week. One patient
reported small erythematous subcutaneous nodules resolving in 17 days. Tenderness of the neck lasting from 2 weeks (n = 2)
to 3 weeks (n = 1) was also reported.
Conclusions: Our data, obtained in an office setting without injectable anesthetic or IV sedation, indicate that monopolar
RF for skin tightening is a very safe procedure. The treatment algorithm and tips have evolved over several years leading to
increased safety and efficacy. Side effects are infrequent, self-limited, and minor, comparing favorably to other nonablative
devices utilized for facial rejuvenation.

Introduction this combination of heating and cooling is epidermal

Sagging skin of the face and neck is a problem commonly
experienced by the baby-boom generation, now reaching the
half-century mark. Invasive surgical procedures, although
effective, require an extended recovery period, cause scarring,
and can result in the appearance of a stretched mouth or an
unnatural facial “skeletonization.” Tissue tightening achieved
by thermal ablation (CO2 or Er:YAG laser) of the dermis is
accompanied by a long recovery period and significant risks.1-3
Due to the long recovery times and risks of side effects of
ablative resurfacing, several nonablative procedures that
affect superficial skin texture have been developed. None of
these, however, address the drooping and stretching of lower
facial skin brought about by gravity.4-6
Numerous reports of a monopolar radiofrequency (RF) device
have indicated that this nonsurgical option for reducing skin
laxity with little or no downtime may be effective to address
sagging of facial skin.7-17 The theory is that carefully
controlled RF can be used for heating to contract deep dermal
tissue without superficial heat injury. RF energy deposition
through a distinctive capacitive coupling membrane is used
together with a timed cryogen cooling spray to regulate the
depth and extent of heating. The most important aspect of
protection from injury while heating collagen in the dermis
and other subcutaneous structures. Recent porcine skin ther-
mography data indicates that RF travels around subcutaneous
fat lobules via the fibrous septae connected to subcutaneous
fascia (Figure 1) (data on file, Thermage Inc, Haywood, CA).
Adverse effects from monopolar RF treatment have been a
topic of conversation at recent meetings of the American
Society of Lasers in Medicine and Surgery. There have been
widespread discussion of possible side effects posted on the
Internet and reported in the media. In order to establish the
actual rate and degree of side effects in our clinical experi-
ence, a retrospective chart review was performed on over 600
consecutive patient treatments performed from May 2002
until June 2006.
Methods
The data reported herein are based on a retrospective chart
review of patients and their images treated with the monopo-
lar RF device (Thermacool®, Thermage Inc, Haywood, CA).
All side effects reported by patients, noted by staff, phoned in,
and/or written in the chart were collated. These collated data
were reviewed and verified by the treating physician as well
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708

JOURNAL OF DRUGS IN DERMATOLOGY MONOPOLAR RADIOFREQUENCY FACIAL TIGHTENING

SEPTEMBER 2006 • VOLUME 5 • ISSUE 8

Figure 1. Infrared thermal image at the end of the application
of energy using a 1.5 cm2 medium treatment tip. The
treatment tip is seen pressing against the epidermal surface of
porcine skin. Cooling is observed as a dark blue area just
below the treatment tip. Heating of the dermis and heating
of the subcutaneous tissue can also be distinguished as lighter
regions with paths of increased temperature through dermal
and fibrous structures outlined. (Courtesy of Thermage, Inc.,
Haywood, CA)
as a nontreating physician. While it is possible that some
patients may have experienced side effects that they did not
report to us, the vast majority of the Thermage-treated
patients have been seen in follow-up for other aesthetic
“fast” tip, fluences of 62 to 109 J/cm2 (level of 72.0 to 76.0)
were utilized with one primary pass over the entire targeted
area with 2 to 4 passes in areas of the greatest laxity. The
multiple-pass, lower-energy technique evolved as the larger
1.5-cm2 “big fast” tip became available. Fluences included 75
to 130 J/cm2 (level of 61.5 to 65, with 62 the mean setting)
and 2 passes were performed over the entire treated area.
Since its availability in 2006, the 3-cm2 tip has been utilized
in a similar fashion with equivalent fluences. Up to an
additional 4 passes were delivered over contour-enhancing
regions and areas of greatest laxity.
When treatment of the neck was performed, the region over
the thyroid gland in the midline of the neck was avoided and
submandibular skin was elevated superiorly to facilitate com-
plete tip contact. A “pinching” technique (forefinger and
thumb used to elevate the treated skin above the underlying
tissues) to reduce local impedance and allow greater fluence
was sometimes directed to the medial cheeks and sagging
jowls, as shown in Figure 3.
A critical aspect for guiding the maximal energy used during
treatment was eliciting patient feedback. Typically, patients
were asked to grade the heat sensation of each pulse on the
following scale: 0 (no pain or heat), 1 (mild heat), 2 (moder-
ate heat), 3 (painful heat), or 4 (intolerable pain or heat).

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procedures. Only a small number (n = 10) did not return for The energy for treatment was adjusted so that most pulses
follow-up after their treatment; this group did not call about were rated at 2. This rating scale has been reported to be an
any side effects. Data from over 600 consecutive treatments effective method to guide treatment.7
were utilized to determine the incidence of side effects in our
patients, who ranged from 38 to 72 years. These patients were
treated for mild to moderate facial and neck skin laxity. Figure 2. A grid is placed on the skin prior to treatment.
Patients were treated at the Maryland Laser, Skin and Vein
Institute in Hunt Valley, Maryland from May 2002 to
June 2006.
The majority of patients had a topical anesthetic cream
applied to the entire treatment area for 45 to 60 minutes
before the procedure, a step that was abandoned in 2005 in
favor of oral anxiolytics and analgesics. To obtain patient
feedback on levels of discomfort during the administration of
RF energy, no intravenous sedation was used. One patient
received local nerve blocks of 1% lidocaine in 2002. Topical
anesthesia typically was 4% lidocaine cream (LMX4, Ferndale
Labs, Ferndale, MI) or 4% tetracaine and 1% lidocaine cream
(Lasercaine, Boswell West Pharmacy, Sun City, AZ).
The oral analgesics typically used were valdecoxib 20 to 40
mg, diazepam 5 to 10 mg, and 500 mg acetaminophen with 5
mg oxycodone. An isopropanol-soluble treatment grid was
applied prior to treatment to ensure uniform application of RF
energy to the entire skin surface (Figure 2). Copious amounts
of coupling fluid were applied to each area of skin just prior to
RF application.
During the multiyear use of the device, treatment parameters
evolved from the feedback of patients and clinical observa-
tion as new tips became available. The original 1.0-cm2
standard tip utilized fluences ranging from 81 to 124 J/cm2
(level of 12.5 to 15) with only 1 to 3 passes. With the 1-cm2
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JOURNAL OF DRUGS IN DERMATOLOGY MONOPOLAR RADIOFREQUENCY FACIAL TIGHTENING

SEPTEMBER 2006 • VOLUME 5 • ISSUE 8

At the conclusion of each treatment, patients were actively Table 1. Side Effects.
encouraged to report back at any time to the Maryland Laser
Skin and Vein Institute if they noticed anything which they Patient Year Side Effect Duration Tip*
perceived as an adverse event, including skin color changes, 1 2003 Neck, chin tenderness 3 weeks S
skin texture changes, pain, persistent erythema, crusting, 2 2003 Edema 2 days F
oozing, bruising, or swelling, particularly if they extended
beyond the first 24 hours posttreatment. Clinical results were 3 2004 Edema, erythema 4 days S
assessed in many patients with live patient examination, 4 2003 Edema, tenderness 3 days S
clinical images using a Canfield reproducible imaging system, 5 2004 Edema on lower eyelid 9 days F
and patient self-assessments of clinical improvement.
6 2003 Neck papule 8 days F
Results 7 2004 4-mm minimal depression 3.5 months S
At the conclusion of the procedure, 90% of the patients
8 2004 Acneiform papules 10 days F
experienced erythema which dissipated in 5 to 20 minutes,
although 5% reported erythema for 24 to 72 hours. 9 2004 Erythema 3 days BF
Unexpected patient-reported and physician-noted side effects 10 2003 Edematous papules 24 hours S
are listed in Table 1. Expected side effects, including mild
facial edema lasting less than 24 hours, was reported by 30% 11 2003 Edema, one area of crusting 1 week S
of patients. Six patients reported edema for up to 1 week and 12 2004 3 acneiform papules 6 days F
another 2 patients for 1 to 2 weeks. This made the treated 13 2003 Erythema, erythematous 4 days
areas appear enlarged rather than contracted, alarming the F
patches
patients, but the edema cleared rapidly. Soreness of the 14 2003 Edema along mandible 1 week S
treated area that lasted 48 hours or less was reported by 38%
of patients. The most significant side effects, all of which 15 2003 Edema perioral 5 days F
occurred using the older 1.0-cm2 original longer cycle tip, 16 2004 Neck tenderness 2 weeks BF

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were a 4-mm linear superficial crust (Figure 4) that resolved 17 2004 Neck tenderness 1 week BF
completely within 1 week, and a slight depression on the
cheek (discovered by the physician in follow-up) which Tips designated as S = slow, 1 cm2, F = fast, 1 cm2, BF = big fast, 1.5 cm2
*

resolved spontaneously within 3.5 months (Figure 5). Three

Figure 3. Demonstration of the “pinching” technique to
reduce local impedance to bony structures below and allow
higher fluence to be delivered. The pinching technique
elevates the skin from the underlying bone reducing imped-
ance and subsequent heat at the level of the periosteum.
cases of subcutaneous erythematous papules, which appeared
acneiform, and one case of erythematous patches appeared
within 3 days and resolved spontaneously within 10 days
(Figure 6). Three patients had tenderness of the neck lasting
1 to 4 weeks. One patient reported by phone that she
experienced small erythematous subcutaneous lesions
lasting for 17 days, although this was not documented
photographically, nor did she feel the necessity to be seen by
a physician. None of our patients experienced pigmentary
change, scarring, or nerve injury, and none of the side effects
were long-term. Of particular interest, no patients have
reported side effects beyond the expected temporary
erythema, edema, and tenderness over the past year. In par-
ticular, we have observed no side effects with the 3-cm2 tip.
The clinical results of monopolar RF have improved with
increased sophistication of treatment algorithms. Table 2
shows the clinical results in terms of patients with noticeable
degrees of skin tightening and correlation with progressively
improved treatment algorithms. These data show that clinical
results have significantly improved over the last 4 years. An
example of a clinically relevant, visible result at 2 months
posttreatment with the multiple-pass, lower-fluence
treatment algorithm using the 1.5-cm2 tip on lower face
contouring is seen in Figure 7.

Discussion
Face and neck skin laxity, periorbital rhytides, and acne have
been reported to be successfully treated by the monopolar RF
device as utilized in this clinical retrospective review.7-16 Mild
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JOURNAL OF DRUGS IN DERMATOLOGY MONOPOLAR RADIOFREQUENCY FACIAL TIGHTENING

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Table 2. Treatment Efficacy for Lower Face Skin Tightening.* self-limited erythema, with or without mild edema, is
expected immediately after treatment from the controlled
Treatment Period Tip† Efficacy Algorithm thermal effects and is not associated with pain. Side effects
2002-2003 S 20% Single pass such as prolonged erythema at 1 month posttreatment in
3.9% of patients, scabbing in 7.7% early on and in 1.4% at
2003-2004 S, F 50% Double pass 2 months, and 21 instances in 15 patients of second degree
burns (0.36% of 5,858 RF applications), were reported in
2004-present S, F, BF, 3cm2 80% Multiple pass a multicenter study.7 Significantly, local nerve blocks, which
would prevent patients from reporting the intensity of
*
Determined by follow-up in 90% of treated patients treatment sensation and the use of the slower cycle tip, were
†
Tips designated as S = slow, 1cm2, F = fast, 1 cm2, BF = Big fast, 1.5 cm2 utilized in the majority of cases with side effects. Forehead
bruising resolving in 3 to 4 weeks was reported in 3 patients
Figure 4. Patient with a mild, linear, superficial crust and 2 patients developed altered sensation. One patient
at 48 hours posttreatment. developed urticarial swelling, again thought to have resulted
from using higher energies in a patient anesthetized with
injectable subcutaneous local anesthesia. In this multicenter
study, all patients were treated with the first generation,
longer cycle 1.0-cm2 tip.
Alster et al reported 56% of patients developed soreness
controlled with oral nonsteroidal anti-inflammatory
medications.8 In this report, 6% developed erythematous
papules resolving within 24 hours, and one patient developed
dysesthesia resolving in 5 days. Again, all patients were
treated with the first generation longer cycle 1.0-cm2 tip. Iyer
et al reported 40 patients receiving facial and/or neck RF

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treatment in which 3 patients developed superficial blisters
which healed without scarring.9 Some patients in this study
were treated with injected nerve blocks. Side effects appear to
be increased without patient feedback on pain. Finzi et al
reported 25 patients (skin types I to V) with mild to severe
facial and neck laxity receiving one treatment session with a
multipass vector technique consisting of 4 to 5 passes target-
Figure 5. Subtle depression (indicated by arrowhead) on ed over specific skin areas.17 Energy levels were kept low and
the left lower cheek which resolved spontaneously within ranged from 62 to 91 J/cm2 per pulse. In the Finzi study, all
3.5 months. patients experienced some immediate erythema and edema,
which had completely resolved in most patients within 48
hours. No severe side effects were seen, specifically scarring or
dyspigmentation. Efficacy was high as digital images revealed
cosmetic improvement in facial and neck laxity in 96%.
The patients treated in our practice had the benefits of
knowledge gained from some of the early experiences, plus
almost all were treated with conservative energy settings. The
slight depression seen in one patient was discovered by the
treating physician during follow-up, not the patient, and was
self-limited. Most importantly, the overwhelming majority of
incidence of adverse reactions in our clinical experience cor-
related with the use of the original longer cycle 1.0 cm2 tip.
Improved shorter cycle tips, tips with skin contact sensors at
all four corners, a treatment algorithm geared towards
multiple passes and lower energy, along with use of the grid on
the skin have greatly reduced the risks of adverse effects. The
use of multiple passes at lower fluences as opposed to one pass
at higher fluences improves tolerability and perceived
improvement.10-11,17,18 Short-term erythema and/or edema is
slightly reduced as well.
The overall rate of temporary unexpected adverse effects at
our site is 2.7%. We have observed no unexpected side effects
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711

JOURNAL OF DRUGS IN DERMATOLOGY MONOPOLAR RADIOFREQUENCY FACIAL TIGHTENING

SEPTEMBER 2006 • VOLUME 5 • ISSUE 8

Figure 6. a) Subcutaneous acneiform papules. These appeared after 3 days and resolved spontaneously within 10 days.
b) Erythematous patches which spontaneously resolved by 10 days posttreatment.
a. b.

for over a year corresponding with the adoption of the References

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The use of new treatment protocols and larger tips 2. Fitzpatrick RE. Maximizing benefits and minimizing risk with CO2

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accompanied by the avoidance of injectable anesthesia or IV
sedation is highly recommended to reduce the possibility of
side effects. In our clinical chart review and experience,
monopolar RF does not have increased risks compared to
other nonablative methods and its use for tightening of the
face and neck is a safe procedure. This treatment modality has
evolved into a highly effective and safe procedure for lower
face skin laxity tightening.
Disclosure
Robert A. Weiss MD has received honoraria and research
funding from and has minor stock in Thermage. Margaret A.
Weiss MD has received research funding from and has minor
stock in Thermage. Girish Munavalli MD MHS has received
honoraria from Thermage. Karen L. Beasley MD has received
research funding from Thermage. This study was not funded
by Thermage.
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Figure 7. a) Patient before and b) 2 months after monopolar radiofrequency treatment. Contouring and tightening
of the lower face and neck are seen after treatment by 5 passes at low fluence.

a. b.
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JOURNAL OF DRUGS IN DERMATOLOGY

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ADDRESS FOR CORRESPONDENCE

Robert A. Weiss MD
Department of Dermatology
Johns Hopkins University School of Medicine
Maryland Laser, Skin and Vein Institute
54 Scott Adam Road, Suite 301
Hunt Valley, MD 21030
e-mail: rweiss@mdlsv.com