HIV Posterior Cheek Enlargement

NCT01635504 | Completed Results

• 1 other identifier: H12-00990
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

HIV Posterior Cheek Enlargement

Keywords

HIV lipoatrophy; masseter hypertrophy; parotid enlargement; botulinum toxin

Outcome Measures

Primary Outcomes (2)

• Percentage Change in Volume of the Masseter Muscle From Baseline to 12 Weeks After Treatment With Botulinum Toxin A

  Baseline and 12 weeks

• Percentage Change in Volume of the Parotid Gland From Baseline to 12 Weeks After Treatment With Botulinum Toxin A

  Baseline and 12 weeks

Study Arms (1)

botulinum toxin A

EXPERIMENTAL

Biological: Botulinum toxin A

Interventions

Botulinum toxin A BIOLOGICAL

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)

Also known as: Botox

botulinum toxin A

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged 19 and older
• Are HIV positive
• Have facial lipoatrophy and a clinically widened lower facial contour

You may not qualify if:

• Have had previous facial injection of any other products
• Have an active infection on the face
• Are receiving active treatment with interferon or systemic corticosteroids
• Are pregnant or breast-feeding
• Have known preexisting renal disease
• Have poorly controlled diabetes mellitus

Sponsors & Collaborators

• University of British Columbia: lead

Study Sites (1)

Carruthers Dermatology Center

Vancouver, British Columbia, V5Z 4E1, Canada

Location

MeSH Terms

Interventions

Botulinum Toxins, Type A

Intervention Hierarchy (Ancestors)

Botulinum Toxins; Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases; Bacterial Proteins; Proteins; Amino Acids, Peptides, and Proteins; Bacterial Toxins; Toxins, Biological; Biological Factors

Limitations and Caveats

This was a pilot study with only 5 participants. This study can only serve as a guide for larger studies.

Results Point of Contact

• Title: Dr. Shannon Humphrey
• Organization: University of British Columbia

shannon@carruthers-humphrey.com

(604) 714-0222

Study Officials

• Alastair Carruthers, MD

  University of British Columbia

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 4, 2012
• First Posted: July 9, 2012
• Study Start: October 1, 2012
• Primary Completion: January 1, 2015
• Study Completion: January 1, 2015
• Last Updated: August 28, 2015
• Results First Posted: June 18, 2015

Record last verified: 2015-08

Locations

CA (1)