HIV Posterior Cheek Enlargement Clinical Trial
Official title:
Posterior Cheek Enlargement in HIV: Anatomic Characterization and Treatment With Botulinum Toxin A
Altered contour of the lower face is a frequent complication of human immunodeficiency virus
(HIV). HIV facial lipoatrophy or loss of facial fat commonly results from antiretroviral
therapy. Posterior cheek enlargement leading to a bulky and widened lower facial contour can
also be seen in HIV. These changes can lead to significant cosmetic disfigurement and have
an enormous psychosocial impact on patients. They also make individuals vulnerable by making
them recognizable as persons living with HIV. Posterior cheek enlargement has not been well
characterized. Both the parotid salivary gland and the masseter muscle are located in the
posterior cheek region. Although parotid gland enlargement in a common complication of HIV,
it is unknown whether enlargement of the masseter muscle also contributes. The investigators
plan to study posterior cheek enlargement in HIV positive individuals. The investigators
also plan to use botulinum toxin A as a novel treatment to improve the altered lower facial
contour seen in HIV. This treatment has already demonstrated efficacy in HIV negative
individuals with enlargement of the masseter muscle. Botulinum toxin has also been used
safely in the salivary glands in individuals with excessive drooling resulting from
neurological disease. In a trial HIV+ patient, the investigators have already demonstrated
the efficacy of using botulinum toxin A in the treatment of posterior cheek enlargement,
resulting from both parotid and masseter muscle enlargement. The investigators anticipate
this study will increase our understanding of posterior cheek enlargement in HIV and lead to
the development of a novel treatment for this important complication.
The investigators hypothesize that posterior cheek enlargement in HIV+ patients will in some
cases result from both masseter muscle hypertrophy as well as parotid gland enlargement. The
investigators also hypothesize that the treatment of posterior cheek enlargement with
botulinum toxin A will result in a more aesthetically appealing lower facial contour in HIV+
patients. This has already been demonstrated in a trial HIV+ patient, in which there was a
dramatic change in the volume of the masseter muscle and parotid gland 12 weeks after
treatment with botulinum toxin A.
BACKGROUND AND SIGNIFICANCE
Altered contour of the lower face is a frequent complication of HIV and can lead to
significant cosmetic disfigurement and social stigmatization. However, posterior cheek
enlargement in HIV is poorly characterized. The parotid and masseter overlie the mandibular
ramus, thus both contributing to the lower facial contour. Parotid hypertrophy is a
recognized and common complication of HIV. It is presently unknown whether masseter muscle
hypertrophy also contributes to this cosmetic deformity. The investigators will conduct a
prospective pilot study in HIV+ patients to determine whether masseter muscle hypertrophy
and parotid gland enlargement contribute to a bulky and widened lower facial contour, or
whether the aesthetic appearance is due primarily to apparent muscle enlargement
attributable to facial lipoatrophy.
Development of novel treatments to address these HIV-associated cosmetic changes is
increasingly important as the burden of this disease expands globally. There have been
limited advances in salivary gland surgery in recent years. The benign nature of parotid
gland hypertrophy requires the surgeon to preserve key anatomical structures as an important
marker of outcome. As such, parotidectomy is a controversial procedure. Treatments for
masseter hypertrophy include surgical reduction of the masseter muscle and resection of the
mandibular angle to create a narrower facial width. These surgical treatments can involve
significant complications such as facial nerve injury, infection, scarring, bleeding,
swelling and trismus. This highlights the need to develop more treatments for posterior
cheek enlargement. Botulinum toxin is a highly efficacious and cost-effective, nonsurgical
option for reducing the width and improving the shape of the lower face and jawline.
Botulinum toxin for masseter hypertrophy and parotid enlargement in HIV negative individuals
and sialorrhea in neurological disease is a safe and effective treatment for these
conditions. However, there are no studies published to date on the use of botulinum toxin in
the setting of HIV. Furthermore, the investigators have already demonstrated the efficacy of
using botulinum toxin A in the treatment of posterior cheek enlargement in a trial HIV+
patient with both parotid enlargement and masseter hypertrophy. This patient had a dramatic
response clinically and demonstrated a 19.0% and 19.4% mean reduction in the volume of the
parotid gland and masseter muscle, respectively, 12 weeks after injection of botulinum toxin
A. He experienced no adverse effects from the injections.
The investigators will use clinical, photographic and radiological evaluations to determine
the efficacy and durability of botulinum toxin A for altered lower facial contour in HIV+
patients. The investigators anticipate that, at a minimum, this study will improve our
understanding of posterior cheek enlargement seen in some HIV+ patients. The results of this
study may translate into a novel and evidence-based use of botulinum toxin for management of
altered lower facial contour in HIV+ patients. This could potentially improve the
psychosocial wellbeing in patients afflicted with this devastating disease.
STUDY PROTOCOL
This will be an initial pilot study with 5 participants. Participants with posterior cheek
enlargement will have photographs taken and a baseline CT scan of the head performed.
Botulinum toxin A will be injected by identifying the inferior border of the zygomatic arch
and mandibular ramus as well as the anterior and posterior demarcation of the posterior
cheek enlargement. Injections will be performed percutaneously by palpation. A total of 10 U
will be injected into 5 evenly spaced points of the posterior cheek enlargement to give a
total dose of 50 U per side.
Participants will be evaluated clinically at 4, 8 and 12 weeks after injection, with
photographs, and by a questionnaire assessing patient satisfaction and side effects. A CT
scan of the head will be performed 12 weeks after injection of botulinum toxin A. Long-term
efficacy of botulinum toxin A will then be evaluated at 6 and 12 months post injection
clinically, with photographs and a questionnaire assessing patient satisfaction and side
effects.
The primary outcome will be the change in volume of the masseter muscle and parotid gland 12
weeks after treatment with botulinum toxin A. The mean change and standard deviation will be
determined. A secondary outcome will be the relative contributions of masseter hypertrophy
and parotid enlargement to posterior cheek enlargement in HIV+ patients. The pre-treatment
volume of the masseter muscle and parotid gland determined in our HIV+ participants will be
compared to those of normal controls published in the literature.
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Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment