Safety and Efficacy of IDP-118 in the Treatment of Plaque Psoriasis
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02462070|
Recruitment Status : Completed
First Posted : June 3, 2015
Results First Posted : August 20, 2020
Last Update Posted : August 20, 2020
- Study Details
- Tabular View
- Study Results
- How to Read a Study Record
|Condition or disease||Intervention/treatment||Phase|
|Plaque Psoriasis||Drug: IDP-118 Lotion Drug: IDP-118 Vehicle Lotion||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||203 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||A Phase 3, Multicenter, Double-Blind, Randomized, Vehicle Controlled Clinical Study to Assess the Safety and Efficacy of IDP-118 in the Treatment of Plaque Psoriasis|
|Actual Study Start Date :||August 11, 2015|
|Actual Primary Completion Date :||November 8, 2016|
|Actual Study Completion Date :||December 1, 2016|
Experimental: IDP-118 Lotion
Drug: IDP-118 Lotion
Other Name: Lotion
Active Comparator: IDP-118 Vehicle Lotion
Drug: IDP-118 Vehicle Lotion
Other Name: Vehicle
- The Percentage of Participants With Treatment Success at Week 8 [ Time Frame: 8 weeks ]Treatment success was defined as at least a 2-grade improvement from Baseline in IGA score and an IGA score equating to "Clear" or "Almost Clear". IGA was based on a 5-point scale ranging from 0 to 4; where 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate, and 4 = severe.
- Percentage of Participants With Treatment Success at Weeks 12, 6, 4, and 2 [ Time Frame: 12 weeks ]Treatment success was defined as at least a 2-grade improvement from Baseline in IGA score and an IGA score equating to "Clear" or "Almost Clear". IGA was based on a 5-point scale ranging from 0 to 4; where 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate, and 4 = severe.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
Key Inclusion Criteria:
- Male or female, of any race, at least 18 years of age (inclusive).
- Freely provides both verbal and written informed consent.
- Has an area of plaque psoriasis appropriate for topical treatment that covers a BSA of at least 3%, but no more than 12%. The face, scalp, palms, soles, axillae and intertriginous areas are to be excluded in this calculation.
- Is willing and able to avoid prolonged exposure of the treatment area to ultraviolet radiation (natural and artificial) for the duration of the study.
- Has a clinical diagnosis of psoriasis at the Baseline visit with an IGA score of 3 or 4. (The face, scalp, palms, soles, axillae and intertriginous areas are to be excluded in this assessment).
Key Exclusion Criteria:
- Has spontaneously improving or rapidly deteriorating plaque psoriasis or pustular psoriasis, as determined by the investigator.
- Presents with psoriasis that was treated with prescription medication and failed to respond to treatment, even partially or temporarily, as determined by the investigator.
- Presents with any concurrent skin condition that could interfere with the evaluation of the treatment areas, as determined by the investigator.
- Is pregnant, nursing an infant, or planning a pregnancy during the study period.
- Has received treatment with any investigational drug or device within 60 days or 5 drug half lives (whichever is longer) prior to the Baseline visit, or is concurrently participating in another clinical study with an investigational drug or device.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02462070
|United States, Alabama|
|Valeant Site 3|
|Mobile, Alabama, United States, 36601|
|United States, California|
|Valeant Site 9|
|Beverly Hills, California, United States, 90210|
|Valeant Site 12|
|Encino, California, United States, 91316|
|Valeant Site 10|
|San Diego, California, United States, 92093|
|Valeant Site 1|
|Santa Rosa, California, United States, 95403|
|United States, Colorado|
|Valeant Site 16|
|Denver, Colorado, United States, 80123|
|United States, Florida|
|Valeant Site 2|
|Tampa, Florida, United States, 33601|
|United States, Indiana|
|Valeant Site 7|
|South Bend, Indiana, United States, 46601|
|United States, Kentucky|
|Valeant Site 8|
|Louisville, Kentucky, United States, 40202|
|United States, Michigan|
|Valeant Site 13|
|Clinton Township, Michigan, United States, 48036|
|United States, New York|
|Valeant Site 14|
|Rochester, New York, United States, 14603|
|United States, Tennessee|
|Valeant Site 6|
|Nashville, Tennessee, United States, 37115|
|United States, Texas|
|Valeant Site 5|
|Austin, Texas, United States, 73344|
|Valeant Site 4|
|Houston, Texas, United States, 77001|
|United States, Virginia|
|Valeant Site 11|
|Norfolk, Virginia, United States, 23501|
|United States, Washington|
|Valeant Site 15|
|Spokane, Washington, United States, 99201|
|Study Director:||Binu J Alexander||Valeant Pharmaceuticals|
|Responsible Party:||Bausch Health Americas, Inc.|
|Other Study ID Numbers:||
|First Posted:||June 3, 2015 Key Record Dates|
|Results First Posted:||August 20, 2020|
|Last Update Posted:||August 20, 2020|
|Last Verified:||August 2020|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||Undecided|
Skin Diseases, Papulosquamous