Trial record 25 of 34 for:    " May 16, 2012":" June 15, 2012"[FIRST-RECEIVED-DATE]AND HIV[CONDITION] AND HIV Infections

HIV Posterior Cheek Enlargement

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01635504
Recruitment Status : Completed
First Posted : July 9, 2012
Results First Posted : June 18, 2015
Last Update Posted : August 28, 2015
Information provided by (Responsible Party):
University of British Columbia

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: HIV Posterior Cheek Enlargement
Intervention: Biological: Botulinum toxin A

  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
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

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

Baseline Measures
   HIV Posterior Cheek Enlargement Group 
Overall Participants Analyzed 
[Units: Participants]
[Units: Participants]
<=18 years   0 
Between 18 and 65 years   5 
>=65 years   0 
[Units: Participants]
Female   1 
Male   4 
parotid gland volumes 
[Units: Participants]

  Outcome Measures

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

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

  Serious Adverse Events

  Other Adverse Events

  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

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

Responsible Party: University of British Columbia Identifier: NCT01635504     History of Changes
Other Study ID Numbers: H12-00990
First Submitted: June 4, 2012
First Posted: July 9, 2012
Results First Submitted: May 27, 2015
Results First Posted: June 18, 2015
Last Update Posted: August 28, 2015