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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. Identifier: NCT01938599
Recruitment Status : Completed
First Posted : September 10, 2013
Last Update Posted : December 1, 2016
Information provided by (Responsible Party):

Brief Summary:
To compare the safety and efficacy profile of AM001 Cream and its vehicle in the treatment of plaque psoriasis.

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 92 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis

Arm Intervention/treatment
Experimental: AM001
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

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. Target Lesion Area [ Time Frame: 12 Weeks ]
    The target lesion area will be measured at baseline and each-post-baseline visit.

  4. Dermatology Life Quality Index (DLQI) [ Time Frame: 12 Weeks ]
    Measured at baseline and week 12.

  5. Pharmacokinetics [ Time Frame: 2 Weeks ]
    Systemic absorption will be determined in a subgroup.

Information from the National Library of Medicine

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.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Subjects must provide Institutional Review Board (IRB) approved 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 3% and up to 20% of the body surface area (not including the 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 minimum plaque elevation of at least moderate severity (PASI grade ≥ 3) at the target lesion site.
  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 Screening and are willing to continue birth control throughout the study.
  7. 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.
  8. 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.
  9. 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:

  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 Screening (as determined by the Investigator).
  8. Subjects who are immunosuppressed.
  9. Subjects who have a history of allergy or a known hypersensitivity to any component of the study medication.
  10. Subjects who have been treated with any systemic steroids within the 4 weeks prior to the study entry.
  11. 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.
  12. 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.
  13. 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.
  14. Subjects who have been treated with lithium, antimalarial agents, or quinidine within the 4 weeks prior to study entry.
  15. Subjects who have received radiation therapy and/or anti-neoplastic agents, or taken any immunosuppressant medication within 3 months prior to study entry.

Information from the National Library of Medicine

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 identifier (NCT number): NCT01938599

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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
Sponsors and Collaborators
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Responsible Party: AmDerma Identifier: NCT01938599    
Other Study ID Numbers: AD-AM001-001
First Posted: September 10, 2013    Key Record Dates
Last Update Posted: December 1, 2016
Last Verified: November 2016
Keywords provided by AmDerma:
Plaque Psoriasis
Additional relevant MeSH terms:
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Skin Diseases
Skin Diseases, Papulosquamous