- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01938599
Study Comparing AM001 Cream to Vehicle in the Treatment of Plaque Psoriasis
November 30, 2016 updated by: AmDerma
A Multi-Center, Double-Blind, Randomized, Vehicle-Controlled, Parallel-Group Study Comparing AM001 Cream to Vehicle in the Treatment of Plaque Psoriasis
To compare the safety and efficacy profile of AM001 Cream and its vehicle in the treatment of plaque psoriasis.
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
92
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Florida
-
Miami, Florida, United States, 33144
- International Dermatology Research, Inc.
-
-
Minnesota
-
Fridley, Minnesota, United States, 55432
- Minnesota Clinical Study Center
-
-
New Mexico
-
Albuquerque, New Mexico, United States, 87106
- Academic Dermatology Association
-
-
North Carolina
-
High Point, North Carolina, United States, 27262
- Dermatology Consulting Services
-
-
Texas
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College Station, Texas, United States, 77845
- J & S Studies
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Subjects must provide Institutional Review Board (IRB) approved written informed consent.
- Subjects must be male or female, at least 18 years of age.
- Subjects with a definite diagnosis of plaque psoriasis that is clinically active (for at least 3 months), involving at least 3% and up to 20% of the body surface area (not including the scalp, face, hands, feet, and intertriginous areas).
- Subjects with an Investigator's Global Assessment (IGA) of disease severity of at least moderate severity (score ≥ 3) as an overall assessment.
- Subjects with a minimum plaque elevation of at least moderate severity (PASI grade ≥ 3) at the target lesion site.
- 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 Screening and are willing to continue birth control throughout the study.
- Subjects must be willing and able to understand and comply with the requirements of the study, apply the study medication as instructed, return for the required treatment period visits, comply with therapy prohibitions, and be able to complete the study.
- Subjects must be in good health, as confirmed by medical history and physical exam, and free from any clinically significant disease/condition, other than plaque psoriasis, that might interfere with the study evaluations.
- Subjects must be willing to limit sun exposure overall. Subjects are prohibited from sunbathing or intentional tanning or intense sun exposure including the use of tanning booths/lights or other artificial UV light sources throughout the study.
Exclusion Criteria:
- Female subjects who are pregnant, nursing, or planning a pregnancy within the study participation period.
- Subjects who have a current diagnosis of guttate, pustular, inverse, exfoliative, or erythrodermic psoriasis.
- Subjects who have a history of psoriasis unresponsive to topical treatments.
- 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.).
- Presence of pigmentation, extensive scarring, or pigmented lesions in the treatment areas, which could interfere with the rating of efficacy parameters.
- Subjects with unstable medical disorders, life-threatening disease, or current malignancies.
- Subjects with clinically significant ECG or laboratory abnormalities at Screening (as determined by the Investigator).
- Subjects who are immunosuppressed.
- Subjects who have a history of allergy or a known hypersensitivity to any component of the study medication.
- Subjects who have been treated with any systemic steroids within the 4 weeks prior to the study entry.
- Subjects who have been treated with systemic or photo antipsoriatic therapies/drugs within 4 weeks prior to study entry including methotrexate, cyclosporine, acitretin and other oral retinoids, broadband or narrowband UVB, PUVA, home or professional tanning lights or other nonprescription UV light sources, photodynamic therapy (PDT), lasers, mycophenalate mofetil (MMF), thioguanine, hydroxyurea, sirolimus, azathioprine, 6-mercaptopurine (6-MP), or etanercept.
- Subjects who have been treated with biologic therapy other than etanercept within 8 weeks prior to study entry. Vaccines will not be considered an exclusionary biologic treatment.
- Subjects who have been treated with any topical anti-psoriatic (e.g., salicylic acid, anthralin, tar, etc.,) any topical corticosteroid medications, topical retinoids (e.g., tazarotene, tretinoin), topical Vitamin D analogs (e.g., calcipotriene), topical immunosuppressants (e.g., tacrolimus, pimecrolimus) within 2 weeks prior to study entry.
- Subjects who have been treated with lithium, antimalarial agents, or quinidine within the 4 weeks prior to study entry.
- Subjects who have received radiation therapy and/or anti-neoplastic agents, or taken any immunosuppressant medication within 3 months prior to study entry.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: AM001
AM001 Cream, 7.5%.
2x daily for 12 weeks.
|
Cream, 2x daily for 12 weeks
|
Placebo Comparator: Vehicle
Placebo of AM001 Cream.
2x daily for 12 weeks.
|
Cream, 2x daily for 12 weeks
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Week 12
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
12 Weeks
|
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.
|
12 Weeks
|
Target Lesion Area
Time Frame: 12 Weeks
|
The target lesion area will be measured at baseline and each-post-baseline visit.
|
12 Weeks
|
Dermatology Life Quality Index (DLQI)
Time Frame: 12 Weeks
|
Measured at baseline and week 12.
|
12 Weeks
|
Pharmacokinetics
Time Frame: 2 Weeks
|
Systemic absorption will be determined in a subgroup.
|
2 Weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2013
Primary Completion (Actual)
May 1, 2014
Study Completion (Actual)
August 1, 2014
Study Registration Dates
First Submitted
September 5, 2013
First Submitted That Met QC Criteria
September 5, 2013
First Posted (Estimate)
September 10, 2013
Study Record Updates
Last Update Posted (Estimate)
December 1, 2016
Last Update Submitted That Met QC Criteria
November 30, 2016
Last Verified
November 1, 2016
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- AD-AM001-001
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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