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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

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ClinicalTrials.gov Identifier: NCT01635504
Recruitment Status : Completed
First Posted : July 9, 2012
Results First Posted : June 18, 2015
Last Update Posted : August 28, 2015
Sponsor:
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
Enrollment 5
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Botulinum Toxin A
Hide Arm/Group Description 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)
Period Title: Overall Study
Started 5
Completed 5
Not Completed 0
Arm/Group Title HIV Posterior Cheek Enlargement Group
Hide Arm/Group Description Patients with HIV posterior cheek enlargement treated with botulinum toxin A
Overall Number of Baseline Participants 5
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 5 participants
<=18 years
0
   0.0%
Between 18 and 65 years
5
 100.0%
>=65 years
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 5 participants
Female
1
  20.0%
Male
4
  80.0%
parotid gland volumes  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 5 participants
5
1.Primary Outcome
Title Percentage Change in Volume of the Masseter Muscle From Baseline to 12 Weeks After Treatment With Botulinum Toxin A
Hide Description [Not Specified]
Time Frame Baseline and 12 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title HIV Posterior Cheek Enlargement Group
Hide Arm/Group Description:
Patients with HIV posterior cheek enlargement treated with botulinum toxin A
Overall Number of Participants Analyzed 5
Mean (Full Range)
Unit of Measure: percentage reduction in masseter volume
21.4
(10 to 27.4)
2.Primary Outcome
Title Percentage Change in Volume of the Parotid Gland From Baseline to 12 Weeks After Treatment With Botulinum Toxin A
Hide Description [Not Specified]
Time Frame Baseline and 12 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title HIV Posterior Cheek Enlargement Group
Hide Arm/Group Description:
Patients with HIV posterior cheek enlargement treated with botulinum toxin A
Overall Number of Participants Analyzed 5
Mean (Full Range)
Unit of Measure: percentage reduction in parotid volume
11.2
(6.4 to 14.6)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title HIV Posterior Cheek Enlargement Group
Hide Arm/Group Description Injected with botulinum toxin A
All-Cause Mortality
HIV Posterior Cheek Enlargement Group
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
HIV Posterior Cheek Enlargement Group
Affected / at Risk (%)
Total   0/5 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
HIV Posterior Cheek Enlargement Group
Affected / at Risk (%)
Total   5/5 (100.00%) 
Gastrointestinal disorders   
dysgeusia  1/5 (20.00%) 
Musculoskeletal and connective tissue disorders   
decrease in bite force *  2/5 (40.00%) 
Skin and subcutaneous tissue disorders   
change in facial expression  1/5 (20.00%) 
sunken cheeks  1/5 (20.00%) 
*
Indicates events were collected by non-systematic assessment
This was a pilot study with only 5 participants. This study can only serve as a guide for larger studies.
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
ClinicalTrials.gov 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