Trial Outcomes & Findings for HIV Posterior Cheek Enlargement (NCT NCT01635504)
NCT ID: NCT01635504
Last Updated: 2015-08-28
Results Overview
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
5 participants
Primary outcome timeframe
Baseline and 12 weeks
Results posted on
2015-08-28
Participant Flow
Participant milestones
| Measure |
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)
|
|---|---|
|
Overall Study
STARTED
|
5
|
|
Overall Study
COMPLETED
|
5
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
HIV Posterior Cheek Enlargement
Baseline characteristics by cohort
| Measure |
HIV Posterior Cheek Enlargement Group
n=5 Participants
Patients with HIV posterior cheek enlargement treated with botulinum toxin A
|
|---|---|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=99 Participants
|
|
parotid gland volumes
|
5 participants
n=99 Participants
|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
5 Participants
n=99 Participants
|
PRIMARY outcome
Timeframe: Baseline and 12 weeksOutcome measures
| Measure |
HIV Posterior Cheek Enlargement Group
n=5 Participants
Patients with HIV posterior cheek enlargement treated with botulinum toxin A
|
|---|---|
|
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
Interval 10.0 to 27.4
|
PRIMARY outcome
Timeframe: Baseline and 12 weeksOutcome measures
| Measure |
HIV Posterior Cheek Enlargement Group
n=5 Participants
Patients with HIV posterior cheek enlargement treated with botulinum toxin A
|
|---|---|
|
Percentage Change in Volume of the Parotid Gland From Baseline to 12 Weeks After Treatment With Botulinum Toxin A
|
11.2 percentage reduction in parotid volume
Interval 6.4 to 14.6
|
Adverse Events
HIV Posterior Cheek Enlargement Group
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
HIV Posterior Cheek Enlargement Group
n=5 participants at risk
Injected with botulinum toxin A
|
|---|---|
|
Musculoskeletal and connective tissue disorders
decrease in bite force
|
40.0%
2/5
|
|
Skin and subcutaneous tissue disorders
change in facial expression
|
20.0%
1/5
|
|
Gastrointestinal disorders
dysgeusia
|
20.0%
1/5
|
|
Skin and subcutaneous tissue disorders
sunken cheeks
|
20.0%
1/5
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place