Study Comparing AM001 Cream to Vehicle 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: NCT01938599|
Recruitment Status : Completed
First Posted : September 10, 2013
Last Update Posted : December 1, 2016
|Condition or disease||Intervention/treatment||Phase|
|Plaque Psoriasis Skin Diseases, Papulosquamous Skin Diseases||Drug: AM001 Cream, 7.5% Drug: Placebo of AM001 Cream||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||92 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Official Title:||A Multi-Center, Double-Blind, Randomized, Vehicle-Controlled, Parallel-Group Study Comparing AM001 Cream to Vehicle in the Treatment of Plaque Psoriasis|
|Study Start Date :||August 2013|
|Actual Primary Completion Date :||May 2014|
|Actual Study Completion Date :||August 2014|
AM001 Cream, 7.5%. 2x daily for 12 weeks.
Drug: AM001 Cream, 7.5%
Cream, 2x daily for 12 weeks
Placebo Comparator: Vehicle
Placebo of AM001 Cream. 2x daily for 12 weeks.
Drug: Placebo of AM001 Cream
Cream, 2x daily for 12 weeks
- Investigator's Global Assessment of Disease Severity (IGA) [ Time Frame: Week 12 ]An overall assessment of disease severity will be performed at each study visit.
- Target Lesion Psoriasis Area Severity Index (PASI) [ Time Frame: 12 Weeks ]Erythema, Scaling and Plaque Elevation of the target lesion will be scored at baseline and at each subsequent study visit.
- Body Surface Area (BSA) [ Time Frame: 12 Weeks ]The % BSA of all treatable psoriatic lesions and regions will be recorded at baseline and at week 12.
- Target Lesion Area [ Time Frame: 12 Weeks ]The target lesion area will be measured at baseline and each-post-baseline visit.
- Dermatology Life Quality Index (DLQI) [ Time Frame: 12 Weeks ]Measured at baseline and week 12.
- Pharmacokinetics [ Time Frame: 2 Weeks ]Systemic absorption will be determined in a subgroup.
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): NCT01938599
|United States, Florida|
|International Dermatology Research, Inc.|
|Miami, Florida, United States, 33144|
|United States, Minnesota|
|Minnesota Clinical Study Center|
|Fridley, Minnesota, United States, 55432|
|United States, New Mexico|
|Academic Dermatology Association|
|Albuquerque, New Mexico, United States, 87106|
|United States, North Carolina|
|Dermatology Consulting Services|
|High Point, North Carolina, United States, 27262|
|United States, Texas|
|J & S Studies|
|College Station, Texas, United States, 77845|