Condition or disease | Intervention/treatment | Phase |
---|---|---|
Acne Vulgaris | Drug: Dapsone gel 7.5% (Torrent Pharmaceuticals Ltd) Drug: ACZONE® (dapsone) gel, 7.5% (Allergan, INC.) Other: Placebo for Dapsone gel 7.5% (Torrent Pharmaceuticals Ltd) | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 1150 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Intervention Model Description: | A multi-center, double-blind, randomized, three-arm, placebo-controlled, parallel-group study |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Masking Description: | Double blind, Randomised |
Primary Purpose: | Treatment |
Official Title: | A Multi-center,Double-blind,Randomized,Three-arm,Placebo-controlled,Parallel-group Study, Comparing Dapsone Gel,7.5% (Torrent Pharma) to Aczone® Gel,7.5% and Both Active Treatments to a Placebo Control in the Treatment of Acne Vulgaris |
Actual Study Start Date : | July 11, 2019 |
Actual Primary Completion Date : | February 3, 2020 |
Actual Study Completion Date : | February 22, 2020 |
Arm | Intervention/treatment |
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Experimental: Dapsone gel, 7.5% (Torrent Pharmaceuticals Ltd.)
Topical, once daily for 84 days
|
Drug: Dapsone gel 7.5% (Torrent Pharmaceuticals Ltd)
Topical gel
|
Active Comparator: ACZONE® (dapsone) gel, 7.5% (Allergan, INC.)
Topical, once daily for 84 days
|
Drug: ACZONE® (dapsone) gel, 7.5% (Allergan, INC.)
Topical gel
|
Placebo Comparator: Placebo for Dapsone gel 7.5% (Torrent Pharmaceuticals Ltd)
Topical, once daily for 84 days
|
Other: Placebo for Dapsone gel 7.5% (Torrent Pharmaceuticals Ltd)
Topical gel
|
Ages Eligible for Study: | 12 Years to 40 Years (Child, Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Subjects who have used any of the following procedures on the face within 1 month prior to baseline or use during the study:
Subjects who have used any of the following treatments within 1 month prior to baseline or during the study:
Subjects who have used any of the following treatments within 2 weeks prior to baseline or during the study:
United States, California | |
Unison Center for Clinical Trials | |
Sherman Oaks, California, United States, 91403 | |
United States, Florida | |
MOORE Clinical Research, Inc. | |
Brandon, Florida, United States, 33511 | |
FXM Clinical Research Miami | |
Miami, Florida, United States, 33175 | |
FXM Clinical Research Miramar | |
Miramar, Florida, United States, 33027 | |
MOORE Clinical Research, Inc. (S. Tampa Site) | |
Tampa, Florida, United States, 33609 | |
MOORE Clinical Research, Inc. (Temple Terrace Site) | |
Temple Terrace, Florida, United States, 33617 | |
Research Institute of Central Florida | |
Winter Park, Florida, United States, 72792 | |
United States, North Carolina | |
Dermatology Consulting Services, PLLC | |
High Point, North Carolina, United States, 27262 | |
United States, Pennsylvania | |
PEAK Research, LLC | |
Upper Saint Clair, Pennsylvania, United States, 15241 | |
United States, Texas | |
3A Research, LLC - WEST | |
El Paso, Texas, United States, 79902 | |
3A Research, LLC - EAST | |
El Paso, Texas, United States, 79925 | |
Belize | |
Dermatology & Skin Surgery Centre/ FXM Research International | |
Belize City, Belize | |
Dr. Moguel's Clinic/ FXM Research International | |
Belize City, Belize |
Study Chair: | Caryn Thompson, MBA | Catawba Research |
Tracking Information | |||||||
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First Submitted Date ICMJE | July 6, 2019 | ||||||
First Posted Date ICMJE | July 11, 2019 | ||||||
Last Update Posted Date | April 2, 2020 | ||||||
Actual Study Start Date ICMJE | July 11, 2019 | ||||||
Actual Primary Completion Date | February 3, 2020 (Final data collection date for primary outcome measure) | ||||||
Current Primary Outcome Measures ICMJE |
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Original Primary Outcome Measures ICMJE | Same as current | ||||||
Change History | |||||||
Current Secondary Outcome Measures ICMJE | Not Provided | ||||||
Original Secondary Outcome Measures ICMJE | Not Provided | ||||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||||
Descriptive Information | |||||||
Brief Title ICMJE | Study Comparing Test to Aczone 7.5% and Both to a Placebo Control in the Treatment of Acne Vulgaris | ||||||
Official Title ICMJE | A Multi-center,Double-blind,Randomized,Three-arm,Placebo-controlled,Parallel-group Study, Comparing Dapsone Gel,7.5% (Torrent Pharma) to Aczone® Gel,7.5% and Both Active Treatments to a Placebo Control in the Treatment of Acne Vulgaris | ||||||
Brief Summary | To evaluate the therapeutic effect of Dapsone and Placebo gel in the treatment of acne vulgaris. | ||||||
Detailed Description | A Multicenter, Double Blind, Randomized, Placebo Controlled, Parallel Group study comparing Dapsone to ACZONE Gel and active treatment to a Placebo control in the treatment of Acne Vulgaris | ||||||
Study Type ICMJE | Interventional | ||||||
Study Phase ICMJE | Phase 3 | ||||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Intervention Model Description: A multi-center, double-blind, randomized, three-arm, placebo-controlled, parallel-group study Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)Masking Description: Double blind, Randomised Primary Purpose: Treatment
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Condition ICMJE | Acne Vulgaris | ||||||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | ||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||
Recruitment Status ICMJE | Completed | ||||||
Actual Enrollment ICMJE |
1150 | ||||||
Original Estimated Enrollment ICMJE | Same as current | ||||||
Actual Study Completion Date ICMJE | February 22, 2020 | ||||||
Actual Primary Completion Date | February 3, 2020 (Final data collection date for primary outcome measure) | ||||||
Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 12 Years to 40 Years (Child, Adult) | ||||||
Accepts Healthy Volunteers ICMJE | Yes | ||||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||
Listed Location Countries ICMJE | Belize, United States | ||||||
Removed Location Countries | |||||||
Administrative Information | |||||||
NCT Number ICMJE | NCT04015375 | ||||||
Other Study ID Numbers ICMJE | DPSG 1812 | ||||||
Has Data Monitoring Committee | No | ||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Responsible Party | Torrent Pharmaceuticals Limited | ||||||
Study Sponsor ICMJE | Torrent Pharmaceuticals Limited | ||||||
Collaborators ICMJE | Catawba Research | ||||||
Investigators ICMJE |
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PRS Account | Torrent Pharmaceuticals Limited | ||||||
Verification Date | March 2020 | ||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |