HIV Posterior Cheek Enlargement
|First Submitted Date ICMJE||June 4, 2012|
|First Posted Date ICMJE||July 9, 2012|
|Results First Submitted Date||May 27, 2015|
|Results First Posted Date||June 18, 2015|
|Last Update Posted Date||August 28, 2015|
|Start Date ICMJE||October 2012|
|Primary Completion Date||January 2015 (Final data collection date for primary outcome measure)|
|Current Primary Outcome Measures ICMJE
|Original Primary Outcome Measures ICMJE
|Change History||Complete list of historical versions of study NCT01635504 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE||Not Provided|
|Original Secondary Outcome Measures ICMJE
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||HIV Posterior Cheek Enlargement|
|Official Title ICMJE||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.
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.
|Study Type ICMJE||Interventional|
|Study Phase||Not Provided|
|Study Design ICMJE||Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Condition ICMJE||HIV Posterior Cheek Enlargement|
|Intervention ICMJE||Biological: Botulinum toxin A
Botulinum toxin A 50 units per side of the posterior cheek enlargement, injected into the masseter muscle and parotid gland (10 units into 5 points of the posterior cheek enlargement per side, giving a total of 100 units per patient)
Other Name: Botox
|Study Arms||Experimental: botulinum toxin A
Intervention: Biological: Botulinum toxin A
|Publications *||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Completed|
|Completion Date||January 2015|
|Primary Completion Date||January 2015 (Final data collection date for primary outcome measure)|
|Eligibility Criteria ICMJE||
|Ages||19 Years and older (Adult, Senior)|
|Accepts Healthy Volunteers||No|
|Contacts ICMJE||Contact information is only displayed when the study is recruiting subjects|
|Listed Location Countries ICMJE||Canada|
|Removed Location Countries|
|NCT Number ICMJE||NCT01635504|
|Other Study ID Numbers ICMJE||H12-00990|
|Has Data Monitoring Committee||No|
|U.S. FDA-regulated Product||Not Provided|
|IPD Sharing Statement||Not Provided|
|Responsible Party||University of British Columbia|
|Study Sponsor ICMJE||University of British Columbia|
|Collaborators ICMJE||Not Provided|
|PRS Account||University of British Columbia|
|Verification Date||August 2015|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP