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COMPLETEDPHASE2

Safety and Efficacy Study Comparing AM001 Cream, 7.5% to Vehicle Cream in the Treatment of Plaque Psoriasis

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

NCT03005964•AmDerma

View on ClinicalTrials.gov

Summary

To compare the safety and efficacy profiles of AM001 Cream, 7.5% and its vehicle cream in the treatment of plaque psoriasis

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Subjects must provide written informed consent.
•2. Subjects must be male or female, at least 18 years of age.
•3. Subjects with a definite diagnosis of plaque psoriasis that is clinically active (for at least 3 months), involving at least 10% and up to 20% of the body surface area (not including the head \[ scalp, face\], hands, feet, and intertriginous areas).
•4. Subjects with an Investigator's Global Assessment (IGA) of disease severity of at least moderate severity (score ≥ 3) as an overall assessment.
•5. Subjects with a target lesion which has the following characteristics:
•1. located on the extremities (i.e., arms or legs ) and has an area of ≥25 cm2;
•2. has a minimum plaque erythema of at least moderate severity (PASI grade ≥ 3);
•3. has a minimum plaque scaling severity of at least moderate severity (PASI grade ≥ 3);
•4. has a minimum plaque elevation of at least moderate severity (PASI grade ≥ 3);
•6. If females of childbearing potential, the subject must have a negative urine pregnancy test, and must have been using an acceptable form of birth control for at least two months prior to Visit 1/Screening and are willing to continue birth control throughout the study.
+3 more criteria

Exclusion Criteria

•1. Female subjects who are pregnant, nursing, or planning a pregnancy within the study participation period.
•2. Subjects who have a current diagnosis of guttate, pustular, inverse, exfoliative, or erythrodermic psoriasis.
•3. Subjects who have a history of psoriasis unresponsive to topical treatments.
•4. Subjects who have a history of a disorder that may interfere with the evaluation of plaque psoriasis (e.g., atopic dermatitis, contact dermatitis, tinea corporis, cutaneous lymphoma, etc.).
•5. Presence of pigmentation, extensive scarring, or pigmented lesions in the treatment areas, which could interfere with the rating of efficacy parameters.
•6. Subjects with unstable medical disorders, life-threatening disease, or current malignancies.
•7. Subjects with clinically significant ECG or laboratory abnormalities at Visit 1/Screening (as determined by the Principal Investigator or designee).
•8. Subjects who are immunosuppressed.
•9. Subjects who have a history of allergy or a known hypersensitivity to any component of the investigational product.
•10. Subjects who have been treated with any systemic steroids within the 4 weeks prior to the study entry (intranasal or inhaled corticosteroids are acceptable if kept constant throughout the study, and intra-articular steroid injections are permissible).
+9 more criteria

Locations (2)

Instituto Dermatogical y Cirugia de Piel

San Cristóbal, Dominican Republic

Instituto Dermatologico Blanco Falette, MD

Santo Domingo, Dominican Republic

Key Dates

Start Date

December 1, 2016

Primary Completion Date

August 15, 2017

Completion Date

September 4, 2017

Last Updated

October 3, 2018

Enrollment

ESTIMATED participants

Conditions

Plaque Psoriasis

Interventions

AM001 Cream, 7.5%

DRUG

Vehicle Cream

DRUG

Long-Term Safety Study of Deucravacitinib Versus Ustekinumab in Participants With Psoriasis (PRAGMATYK)

NCT07116967

Plaque Psoriasis

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RECRUITINGPHASE3

A Long-Term Study of Zasocitinib in Children and Teenagers With Plaque Psoriasis

NCT07250802

Plaque Psoriasis

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RECRUITINGPHASE2

An Open-Label Extension Study of ORKA-001 in Participants With Plaque Psoriasis

NCT07449702

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 3, 2018Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Safety and Efficacy Study Comparing AM001 Cream, 7.5% to Vehicle Cream in the Treatment of Plaque Psoriasis

Inclusion Criteria

Exclusion Criteria

Long-Term Safety Study of Deucravacitinib Versus Ustekinumab in Participants With Psoriasis (PRAGMATYK)

A Long-Term Study of Zasocitinib in Children and Teenagers With Plaque Psoriasis

An Open-Label Extension Study of ORKA-001 in Participants With Plaque Psoriasis

Dose Ranging Study of ORKA-001 in Patients With Moderate-to-Severe Plaque Psoriasis

A Study to Assess the Concentration of Bimekizumab in Mature Breast Milk From Mothers Receiving Treatment With Bimzelx® (Bimekizumab)

A Study to Evaluate Effectiveness and Safety of a TYK2 Inhibitor in Subjects With Moderate to Severe Plaque Psoriasis