Back to resultsStudy Comparing Test to Aczone 7.5% and Both to a Placebo Control in the Treatment of Acne Vulgaris
Primary Purpose
Acne Vulgaris
Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
DPSG 7.5%
Aczone
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Acne Vulgaris
Eligibility Criteria
Inclusion Criteria:
- Healthy male or non pregnant female aged ≥ 12 years with a clinical diagnosis of acne vulgaris.
Exclusion Criteria:
- Female Subjects who are pregnant, nursing or planning to become pregnant during study participation
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Placebo Comparator
Active Comparator
Arm Label
DPSG 7.5%
Vehicle Gel
Aczone
Arm Description
DPSG 7.5% (Taro Pharmaceuticals USA) Topical, twice daily on the face for 84 days.
Placebo product (Taro Pharmaceuticals Inc.) Topical, twice daily on the face for 84 days.
dapsone 7.5 Topical, twice daily on the face for 84 days.
Outcomes
Primary Outcome Measures
Change in inflammatory lesion counts
Percent change from baseline to week 12 in the inflammatory (papules and pustules) lesion counts
Change in non-inflammatory lesion counts
Percent change from baseline to week 12 in the non-inflammatory (open and closed comedones) lesion counts
Secondary Outcome Measures
Clinical response of success
The proportion of subjects with a clinical response of success at week 12, success defined as an Investigator's Global Assessment score that is at least two grades less than the baseline assessment
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03132194
Brief Title
Study Comparing Test to Aczone 7.5% and Both to a Placebo Control in the Treatment of Acne Vulgaris
Official Title
A Single-center, Double-blind, Randomized, Parallel-group Study, Comparing DPSG to a Placebo Control in the Treatment of Acne Vulgaris
Study Type
Interventional
2. Study Status
Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
August 8, 2016 (Actual)
Primary Completion Date
January 16, 2017 (Actual)
Study Completion Date
January 30, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Taro Pharmaceuticals USA
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
To evaluate the therapeutic effect of DPSG and Placebo gel in the treatment of acne vulgaris.
Detailed Description
A Multi-center, Double-Blind, Randomized, Placebo Controlled, Parallel-Group study comparing DPSG to ACZONE Gel and active treatment to a Placebo control in the treatment of Acne Vulgaris.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acne Vulgaris
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
1125 (Actual)
8. Arms, Groups, and Interventions
Arm Title
DPSG 7.5%
Arm Type
Experimental
Arm Description
DPSG 7.5% (Taro Pharmaceuticals USA)
Topical, twice daily on the face for 84 days.
Arm Title
Vehicle Gel
Arm Type
Placebo Comparator
Arm Description
Placebo product (Taro Pharmaceuticals Inc.)
Topical, twice daily on the face for 84 days.
Arm Title
Aczone
Arm Type
Active Comparator
Arm Description
dapsone 7.5
Topical, twice daily on the face for 84 days.
Intervention Type
Drug
Intervention Name(s)
DPSG 7.5%
Other Intervention Name(s)
dapsone
Intervention Description
topical gel
Intervention Type
Drug
Intervention Name(s)
Aczone
Other Intervention Name(s)
dapsone
Intervention Description
topical gel
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
Vehicle
Intervention Description
topical gel
Primary Outcome Measure Information:
Title
Change in inflammatory lesion counts
Description
Percent change from baseline to week 12 in the inflammatory (papules and pustules) lesion counts
Time Frame
12 weeks
Title
Change in non-inflammatory lesion counts
Description
Percent change from baseline to week 12 in the non-inflammatory (open and closed comedones) lesion counts
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Clinical response of success
Description
The proportion of subjects with a clinical response of success at week 12, success defined as an Investigator's Global Assessment score that is at least two grades less than the baseline assessment
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Healthy male or non pregnant female aged ≥ 12 years with a clinical diagnosis of acne vulgaris.
Exclusion Criteria:
Female Subjects who are pregnant, nursing or planning to become pregnant during study participation
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Catawba Research
Organizational Affiliation
http://catawbaresearch.com/contact/
Official's Role
Study Chair
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Study Comparing Test to Aczone 7.5% and Both to a Placebo Control in the Treatment of Acne Vulgaris
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