N/A
N=5
HIV Posterior Cheek Enlargement
HIV Posterior Cheek Enlargement
Bottom Line
View on ClinicalTrials.gov: NCT01635504 ↗Enrolled (actual)
5
Serious AEs
0.0%
Results posted
Jun 2015
Primary outcome: Primary: Percentage Change in Volume of the Masseter Muscle From Baseline to 12 Weeks After Treatment With Botulinum Toxin A — 21.4 percentage reduction in masseter volume
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Botulinum toxin A (Biological)
- Age
- Adult, Older Adult · 19+ yrs
- Sex
- All
- Sponsor
- University of British Columbia
- Primary completion
- Jan 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage Change in Volume of the Masseter Muscle From Baseline to 12 Weeks After Treatment With Botulinum Toxin A |
21.4 | — |
| PRIMARY Percentage Change in Volume of the Parotid Gland From Baseline to 12 Weeks After Treatment With Botulinum Toxin A |
11.2 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Aged 19 and older
- Are HIV positive
- Have facial lipoatrophy and a clinically widened lower facial contour
Exclusion Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT01635504). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.