HIV Posterior Cheek Enlargement

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of British Columbia
ClinicalTrials.gov Identifier:
NCT01635504
First received: June 4, 2012
Last updated: May 27, 2015
Last verified: May 2015
Results First Received: May 27, 2015  
Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: HIV Posterior Cheek Enlargement
Intervention: Biological: Botulinum toxin A

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
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)

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)


Participant Flow:   Overall Study
    Botulinum Toxin A  
STARTED     5  
COMPLETED     5  
NOT COMPLETED     0  



  Baseline Characteristics
  Hide Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
HIV Posterior Cheek Enlargement Group Patients with HIV posterior cheek enlargement treated with botulinum toxin A

Baseline Measures
    HIV Posterior Cheek Enlargement Group  
Number of Participants  
[units: participants]
  5  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     5  
>=65 years     0  
Gender  
[units: participants]
 
Female     1  
Male     4  
parotid gland volumes  
[units: participants]
  5  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Change in Volume of the Masseter Muscle 12 Weeks After Treatment With Botulinum Toxin A   [ Time Frame: 12 weeks ]

2.  Primary:   Change in Volume of the Parotid Gland 12 Weeks After Treatment With Botulinum Toxin A   [ Time Frame: 12 weeks ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
This was a pilot study with only 5 participants. This study can only serve as a guide for larger studies.


  More Information
  Hide More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Dr. Shannon Humphrey
Organization: University of British Columbia
phone: (604) 714-0222
e-mail: shannon@carruthers-humphrey.com


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
Results First Received: May 27, 2015
Last Updated: May 27, 2015
Health Authority: Canada: Health Canada