Acne Studies

Sponsor: Symbio PI: KWD Phase: 2
A Multicenter, Randomized, Double-Blind, Parallel-Group, Vehicle-Controlled Study of the Safety and Efficacy of DFD-03 Lotion in the Treatment of Acne Vulgaris for 12 Weeks DFD-03-CD-006
August 2017- Present

Sponsor: Foamix PI: KWD Phase: 2
A Randomized, Double-Blind, Vehicle-Controlled Study to Evaluate the Efficacy and Safety of Topical Administration of FMX101 for 12 Weeks in the Treatment of Moderate-to-Severe Acne Vulgaris FX2017-22
July 2017- Present

Sponsor: Foamix PI: SAF Phase: 3
A Randomized, Double-Blind Study to compare the efficacy, safety and Long-term safety of topical administration or FMX-101 for 1 year in the treatment of Moderate-to-Severe Acne Vulgaris. FX2014-05
July 2016- April 2017

Sponsor: Valeant PI: KWD Phase: 1B
A Phase Ib Open-Label, Randomized Study Evaluating the Absorption and Systemic Pharmacokinetics of Topically Applied IDP-123 Lotion in Comparison with Tazorac Cream 0.1% in Subjects with Acne Vulgaris under Maximal Use Conditions. – V01-121A-501
June 2016- March 2017

Sponsor: Dow Pharmaceutical Sciences PI: SAF Phase: 3
A Phase III, Multi-Center, Randomized, Double-Blind, Vehicle-Controlled, 2-Arm, Parallel Group Comparison Study Comparing the Efficacy and Safety of IDP-121 and IDP-121 Vehicle Lotion in the Treatment of Acne Vulgaris – V01-121A-302
October 2015 to May 2017

Sponsor: Ranbaxy PI: KWD Phase: 4
A Phase IV Open-Label Study Evaluating the Long-term Efficacy, Quality of Life, and Safety of ABSORICA® (isotretinoin) Capsules Administered Without Food in Patients With Severe Recalcitrant Nodular Acne – ABS1517LT
February 2015 to Present

Sponsor: Allergan (North America) PI: Phase: 3
A Safety and Efficacy Study to Compare Dapsone Dermal Gel with Vehicle Control in Patients with Acne Vulgaris – 225678-007
January 2014 to January 2015

Sponsor: Taro Pharmaceuticals PI: Phase:
A Multicenter, Double-Blind, Randomized, Vehicle-Controlled, Parallel-Group Study Comparing Taro Pharmaceuticals, Inc.’s Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2%/2.5% to the Reference Listed Acanya® (Clindamycin Phosphate and Benzoyl Peroxide) Gel, 1.2%/2.5%, and both Active Treatments to a Vehicle Control in the Treatment of Acne Vulgaris – CLBG1210
January 2013 to February 2014

Sponsor: Warner Chilcott PI: Phase:
A Randomized, Multicenter, Double-Blind, Placebo-controlled Study to Evaluate the Safety and Efficacy of 3 Different doses of a Novel Tetracycline, Compared to Placebo in Treatment of Facial Acne Vulgaris – PR-10411
May 2012 to December 2012

Sponsor: Dow Pharmaceutical Sciences, Inc PI: Phase: 2
A Phase II, Multicenter, Randomized, Double-Blind, Dose-Ranging Study to Evaluate IDP-107 Versus Placebo in the Treatment of Severe Acne Vulgaris with Nodules – DPSI-IDP-107-P2-02
August 2010 to June 2011

Sponsor: Stiefel, a GSK company PI: Phase: 3
A Phase III, Multicenter, Randomized, Double-Blind, Vehicle-Controlled, Parallel-Group Study to Evaluate the Safety and Efficacy of Tazarotene Foam, 0.1%, in Subjects With Acne Vulgaris – W0260-301
October 2009 to January 2011

Sponsor: Cipher Pharmaceuticals PI: Phase: 3
A Double-Blind, Randomized, Phase III, Parallel Group Study Evaluating the Efficacy and Safety of CIP-Isotretinoin in Patients with Severe Recalcitrant Nodular Acne – ISOCT.08.01
October 2009 to October 2011

Sponsor: Stiefel Laboratories PI: Phase: 3
A Phase III, Multicenter, Randomized, Double-blind, Active and Vehicle-Controlled Study of the Safety and Efficacy of Duac Low-Dose Gel Versus Clindamycin Gel versus Benzoyl Peroxide Gel versus Vehicle Gel in Subjects with Acne Vulgaris – W0261-301
October 2008 to 2009

Sponsor: Novum Pharmaceutical Research PI: Phase:
A Randomized, Double-Blind, Multiple-Site, Placebo-Controlled Study Comparing XXXXX to XXXXX in the Treatment of Moderate to Severe Acne Vulgaris.
October 2007 to September 2008

Sponsor: Galderma R&D Inc. PI: Phase:
A Multi-Center, Randomized, Double-Blind, Parallel Group Study to Demonstrate Safety and Efficacy of a Fixed-Combination of a Topical Retinoid and Benzoyl Peroxide 2.5% Gel Compared With the Monads and Corresponding Topical Gel Vehicle.
October 2006 to June 2007

Sponsor: Johnson & Johnson PI: Phase: 4
A Open-label, Community Based, Phase IV Study to Assess Facial Acne Improvement with Use of RETIN-A MICRO® (Tretinoin Gel) Microsphere, 0.04% or 0.1% in a Pump Dispenser
September 2006 to June 2007

Sponsor: Allergan PI: Phase:
A Clinical Evaluation of XXXXX Indicated for the Topical Treatment of Patients with Acne Vulgaris, Who Do Not Want To or Are Unable to participate in the iPLEDGE Program.
May 2006 to July 2006

Sponsor: Concordia Clinical Research, Inc. PI: Phase: 4
A Phase IV, Open-Label, Multicenter, Community-based, 4-Week Trial Assessing Efficacy, Tolerance to Treatment, and Subject Satisfaction with XXXXX.
March 2006 to June 2006