HIV Posterior Cheek Enlargement

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
University of British Columbia
ClinicalTrials.gov Identifier:
NCT01635504
First received: June 4, 2012
Last updated: March 10, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention
HIV Posterior Cheek Enlargement
Biological: Botulinum toxin A

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Posterior Cheek Enlargement in HIV: Anatomic Characterization and Treatment With Botulinum Toxin A

Resource links provided by NLM:


Further study details as provided by University of British Columbia:

Primary Outcome Measures:
  • change in volume of the masseter muscle 12 weeks after treatment with botulinum toxin A [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • change in volume of the parotid gland 12 weeks after treatment with botulinum toxin A [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • relative contribution of masseter hypertrophy to posterior cheek enlargement in HIV+ patients [ Time Frame: baseline ] [ Designated as safety issue: No ]
    The pre-treatment volume of the masseter muscle determined in our HIV+ participants will be compared to those of normal controls published in the literature.

  • relative contribution of the parotid gland to posterior cheek enlargement in HIV+ patients [ Time Frame: baseline ] [ Designated as safety issue: No ]
    The pre-treatment volume of the parotid gland determined in our HIV+ participants will be compared to those of normal controls published in the literature.


Estimated Enrollment: 5
Study Start Date: October 2012
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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)
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

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   19 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Aged 19 and older
  2. Are HIV positive
  3. Have facial lipoatrophy and a clinically widened lower facial contour

Exclusion Criteria:

  1. Have had previous facial injection of any other products
  2. Have an active infection on the face
  3. Are receiving active treatment with interferon or systemic corticosteroids
  4. Are pregnant or breast-feeding
  5. Have known preexisting renal disease
  6. Have poorly controlled diabetes mellitus
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01635504

Locations
Canada, British Columbia
Carruthers Dermatology Center
Vancouver, British Columbia, Canada, V5Z 4E1
Sponsors and Collaborators
University of British Columbia
Investigators
Principal Investigator: Alastair Carruthers, MD University of British Columbia
  More Information

No publications provided

Responsible Party: University of British Columbia
ClinicalTrials.gov Identifier: NCT01635504     History of Changes
Other Study ID Numbers: H12-00990
Study First Received: June 4, 2012
Last Updated: March 10, 2014
Health Authority: Canada: Health Canada

Keywords provided by University of British Columbia:
HIV lipoatrophy
masseter hypertrophy
parotid enlargement
botulinum toxin

Additional relevant MeSH terms:
Hypertrophy
Pathological Conditions, Anatomical
Botulinum Toxins, Type A
Botulinum Toxins
Neuromuscular Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Dyskinesia Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 22, 2014