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Safety and Efficacy of the Use of Botox on Acne

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ClinicalTrials.gov Identifier: NCT00765375
Recruitment Status : Terminated (Investigator decision)
First Posted : October 2, 2008
Results First Posted : April 30, 2015
Last Update Posted : June 29, 2018
Sponsor:
Information provided by (Responsible Party):
Steven H. Dayan, DeNova Research

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: Double (Participant, Outcomes Assessor);   Primary Purpose: Treatment
Condition Acne Vulgaris
Interventions Drug: Botulinum Neurotoxin Type A
Drug: Bacteriostatic saline
Enrollment 5
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Active on One Side, Placebo on the Other Side of Face
Hide Arm/Group Description Botulinum Neurotoxin Type A (Botox) treatment on one side of the face and bacteriostatic saline solution (Placebo) on the other side of the face.
Period Title: Overall Study
Started 5
Completed 5
Not Completed 0
Arm/Group Title Active on One Side and Placebo on the Other Side of Face
Hide Arm/Group Description Botulinum Neurotoxin Type A (Botox) on one side of face, and bacteriostatic saline solution on the other side of face.
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%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 5 participants
21  (2.236)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 5 participants
Female
4
  80.0%
Male
1
  20.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 5 participants
5
1.Primary Outcome
Title Change in Mean Lesion Count From Baseline at 90 Days
Hide Description 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)
Time Frame Baseline and 90 days
Hide Outcome Measure Data
Hide Analysis Population Description
All subjects completing Day 90 visit
Arm/Group Title 1- Active 2- Placebo
Hide Arm/Group Description:
Botulinum Neurotoxin Type A (Botox)
Saline Solution
Overall Number of Participants Analyzed 5 5
Mean (Standard Deviation)
Unit of Measure: Lesions
18.8  (7.33) 15.8  (9.52)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title 1- Active 2- Placebo
Hide Arm/Group Description Botulinum Neurotoxin Type A (Botox) Saline Solution
All-Cause Mortality
1- Active 2- Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
1- Active 2- Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/5 (0.00%)   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%
1- Active 2- Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/5 (0.00%)   0/5 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Jack Arkins, Data Manager
Organization: DeNova Research
Phone: 312-335-2070
EMail: jack@drdayan.com
Layout table for additonal information
Responsible Party: Steven H. Dayan, DeNova Research
ClinicalTrials.gov Identifier: NCT00765375     History of Changes
Other Study ID Numbers: BTX-D-001
First Submitted: September 30, 2008
First Posted: October 2, 2008
Results First Submitted: August 29, 2012
Results First Posted: April 30, 2015
Last Update Posted: June 29, 2018