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Highly Purified
Silicone Oil (Silskin) for Treatment of HIV-related Facial Lipoatrophy:
A Pilot Study
Facial
lipoatrophy (fat loss) has become epidemic among
HIV positive individuals. Those affected are stigmatized, and experience
psychological
distress, social and career impediments, and impaired
adherence
to HIV medications.
The
FDA recently approved Sculptra
(Poly-L-Lactic acid) for the treatment of facial
lipoatrophy. In Europe the injectable compound is known as New Fill.
However, Sculptra is very expensive, costing about $1000 per vial
plus the doctor’s fee.
Other
temporary treatment options are also limited by excessive cost,
necessity of frequent treatments, and lack of a natural look or
feel beneath the skin.
Affected
patients require more persistent, affordable, safe, and effective
treatment options, write the authors of the current article, published
in Dermatologic Surgery.
The
objective was to evaluate the safety and efficacy of highly purified
1000-cSt silicone oil (Silskin)
injected
by micro droplet serial puncture technique for the treatment of
HIV-associated lipoatrophy.
Silskin
is a dermal filler (not FDA-approved) that is used for facial augmentation
including lips, lines, cheeks, and under-eyes. It has also been
used to treat HIV
associated facial wasting, but is not approved in the US for this purpose, nor
for treatment of HIV-related lipoatrophy.
Data
on 77 patients with a complete correction were analyzed to determine
the number of treatments, amount of silicone, and time required
to reach complete correction, relative to initial severity.
Results
The
volume of silicone, number of treatments, and time required to reach
a complete correction were directly related to initial severity
of lipoatrophy (p < 0.0001).
Supple,
even facial contours were routinely restored, with all patients
tolerating treatments well.
No
adverse events were noted.
Conclusion
The
authors conclude, “In this pilot trial, we have demonstrated that
highly purified 1000-cSt silicone oil is a safe and effective treatment
option for human immunodeficiency virus facial lipoatrophy. Longer-term
safety and efficacy in human immunodeficiency virus patients remain
to be proven.”
DR.
JONES IS AN INVESTIGATOR AND HAS SERVED AS A SPEAKER FOR R. J. DEVELOPMENT
(PEABODY, MA), THE MANUFACTURER OF SILSKIN. AS A BIOSTATISTICIAN
RESPONSIBLE FOR THE STATISTICAL ANALYSES OF THE DATA, AS WELL AS
THE PREPARATION OF THE RESULTS SECTION, STANLEY AZEN INVOICED RICHARD
JAMES (THE COMPANY THAT PROVIDED THE SILICONE OIL) FOR CONSULTING
HOURS FOR HIS TIME AND THE TIME OF THE STATISTICIAN/PROGRAMMER.
R.J. DEVELOPMENT (PEABODY, MA) SUPPLIED VITRESIL 1000 TO DR. CARRUTHERS
AND COMPENSATED DR. AZEN FOR THE STATISTICAL ANALYSIS OF THE DATA.
Division
of Dermatology, David Geffen School of Medicine, University of California
at Los Angeles, Los Angeles, California.
10/15/04
Reference
D
H Jones and others. Highly Purified 1000-cSt Silicone Oil for Treatment
of Human Immunodeficiency Virus-Associated Facial Lipoatrophy: An
Open Pilot Trial. Dermatologic Surgery 30(10): 1279-1286.
October 2004.
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