Safety and Efficacy Study Comparing AM001 Cream, 7.5% to Vehicle Cream in the Treatment of Plaque Psoriasis
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|ClinicalTrials.gov Identifier: NCT03005964|
Recruitment Status : Completed
First Posted : December 30, 2016
Last Update Posted : October 3, 2018
|Condition or disease||Intervention/treatment||Phase|
|Plaque Psoriasis||Drug: AM001 Cream, 7.5% Drug: Vehicle Cream||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||74 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, 7.5% to Vehicle Cream in the Treatment of Plaque Psoriasis|
|Study Start Date :||December 2016|
|Actual Primary Completion Date :||August 15, 2017|
|Actual Study Completion Date :||September 4, 2017|
Experimental: AM001 Cream, 7.5%
A white to off-white Cream free from any foreign particles
Drug: AM001 Cream, 7.5%
Other Name: Potassium Dobesilate
Placebo Comparator: Vehicle Cream
A white to off-white Cream free from any foreign particles.
Drug: Vehicle Cream
Other Name: Placebo Cream
- Investigator's Global Assessment of Disease Severity (IGA) [ Time Frame: 12 weeks ]An 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
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): NCT03005964
|Instituto Dermatogical y Cirugia de Piel|
|San Cristobal, Dominican Republic|
|Instituto Dermatologico Blanco Falette, MD|
|Santo Domingo, Dominican Republic|