Trial Outcomes & Findings for Safety and Efficacy of the Use of Botox on Acne (NCT NCT00765375)
NCT ID: NCT00765375
Last Updated: 2018-06-29
Results Overview
To determine the safety and efficacy of Botox Treatment in subjects with mild to moderate acne vulgaris defined by the Investigator's Global Assessment (IGA)
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
5 participants
Primary outcome timeframe
Baseline and 90 days
Results posted on
2018-06-29
Participant Flow
Participant milestones
| Measure |
Active on One Side, Placebo on the Other Side of Face
Botulinum Neurotoxin Type A (Botox) treatment on one side of the face and bacteriostatic saline solution (Placebo) on the other side of the face.
|
|---|---|
|
Overall Study
STARTED
|
5
|
|
Overall Study
COMPLETED
|
5
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Safety and Efficacy of the Use of Botox on Acne
Baseline characteristics by cohort
| Measure |
Active on One Side and Placebo on the Other Side of Face
n=5 Participants
Botulinum Neurotoxin Type A (Botox) on one side of face, and bacteriostatic saline solution on the other side of face.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
5 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
21 years
STANDARD_DEVIATION 2.236 • n=5 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
5 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and 90 daysPopulation: All subjects completing Day 90 visit
To determine the safety and efficacy of Botox Treatment in subjects with mild to moderate acne vulgaris defined by the Investigator's Global Assessment (IGA)
Outcome measures
| Measure |
1- Active
n=5 Participants
Botulinum Neurotoxin Type A (Botox)
|
2- Placebo
n=5 Participants
Saline Solution
|
|---|---|---|
|
Change in Mean Lesion Count From Baseline at 90 Days
|
18.8 Lesions
Standard Deviation 7.33
|
15.8 Lesions
Standard Deviation 9.52
|
Adverse Events
1- Active
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
2- Placebo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place