Clinical Trial To Evaluate ANT-1207 In Subjects With Acne

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Anterios Inc.
ClinicalTrials.gov Identifier:
NCT01293552
First received: February 9, 2011
Last updated: June 28, 2013
Last verified: June 2013

February 9, 2011
June 28, 2013
January 2011
April 2012   (final data collection date for primary outcome measure)
Efficacy will be assessed by lesion count. [ Time Frame: Week 4 ] [ Designated as safety issue: No ]
inflammatory lesion count (papules, pustules, and nodules) and non-inflammatory lesion count (open and closed comedones)
Same as current
Complete list of historical versions of study NCT01293552 on ClinicalTrials.gov Archive Site
  • Change from Baseline in Investigator Global Assessment Score [ Time Frame: Week 1, 2, 4, 8, and 12 ] [ Designated as safety issue: No ]
  • Change from Baseline in Lesion Count [ Time Frame: Week 1, 2, 4, 8, 12 ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Clinical Trial To Evaluate ANT-1207 In Subjects With Acne
Clinical Trial To Evaluate Botulinum Neurotoxin Type A (ANT-1207) In Subjects With Acne

The purpose of this study is to provide evidence of the safety, tolerance, and efficacy of ANT-1207 in the treatment of acne.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Acne Vulgaris
  • Biological: ANT-1207
    single dose application
  • Biological: Vehicle
    Other Name: Placebo
  • Placebo Comparator: Control
    blank vehicle formulation
    Intervention: Biological: Vehicle
  • Experimental: Dose 1
    Dose 1
    Intervention: Biological: ANT-1207
  • Experimental: Dose 2
    Dose 2
    Intervention: Biological: ANT-1207
  • Experimental: Dose 3
    Dose 3
    Intervention: Biological: ANT-1207
  • Experimental: Dose 4
    Dose 4
    Intervention: Biological: ANT-1207
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
72
July 2012
April 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • diagnosis of moderate to severe facial acne
  • 15 to 40 papules and pustules, and 5 to 50 open and/or closed comedones
  • no presence of nodules
  • female subjects must be not pregnant and non-lactating

Exclusion Criteria:

  • presence of 1 or more nodules
  • use of topical steroids on the face 4 weeks prior and during the study
  • use of systemic corticosteroids 6 weeks prior and during the study
  • topical or systemic acne treatment in the 4 weeks prior to Baseline
Both
18 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01293552
ANT-1207-101-ACNE
Yes
Anterios Inc.
Anterios Inc.
Not Provided
Not Provided
Anterios Inc.
June 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP