Trial record 2 of 2906 for:    Open Studies | "Skin Diseases"

Study Comparing AM001 Cream to Vehicle in the Treatment of Plaque Psoriasis

This study is currently recruiting participants.
Verified September 2013 by AmDerma
Sponsor:
Information provided by (Responsible Party):
AmDerma
ClinicalTrials.gov Identifier:
NCT01938599
First received: September 5, 2013
Last updated: NA
Last verified: September 2013
History: No changes posted
  Purpose

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


Condition Intervention Phase
Plaque Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
Drug: AM001 Cream, 7.5%
Drug: Placebo of AM001 Cream
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:


Further study details as provided by AmDerma:

Primary Outcome Measures:
  • Investigator's Global Assessment of Disease Severity (IGA) [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
    An overall assessment of disease severity will be performed at each study visit.


Secondary Outcome Measures:
  • Target Lesion Psoriasis Area Severity Index (PASI) [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    The target lesion area will be measured at baseline and each-post-baseline visit.

  • Dermatology Life Quality Index (DLQI) [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]
    Measured at baseline and week 12.

  • Pharmacokinetics [ Time Frame: 2 Weeks ] [ Designated as safety issue: Yes ]
    Systemic absorption will be determined in a subgroup.


Estimated Enrollment: 90
Study Start Date: September 2013
Estimated Study Completion Date: May 2014
Estimated Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01938599

Contacts
Contact: W. Todd Kays, Ph.D. 631-952-0214 ext 183 toddk@amneal.com

Locations
United States, Florida
International Dermatology Research, Inc. Recruiting
Miami, Florida, United States, 33144
Contact: Fabio Azevedo    305-225-0400    fazevedo@intldermresearch.com   
Principal Investigator: Javier Alonso-Llamazares, MD         
United States, Minnesota
Minnesota Clinical Study Center Recruiting
Fridley, Minnesota, United States, 55432
Contact: Dawn Snow    763-571-4200    dsnow@associatedskincare.com   
Principal Investigator: Steven Kempers, MD         
United States, New Mexico
Academic Dermatology Association Recruiting
Albuquerque, New Mexico, United States, 87106
Contact: Alicia Bucko, DO    505-247-4220    abucko@abqdermtrials.com   
Principal Investigator: Eduardo Tschen, MD         
United States, North Carolina
Dermatology Consulting Services Recruiting
High Point, North Carolina, United States, 27262
Contact: Zoe Draelos, MD    336-841-2040    zdraelos@northstate.net   
Principal Investigator: Zoe Draelos, MD         
United States, Texas
J & S Studies Recruiting
College Station, Texas, United States, 77845
Contact: Jeremy Scott, BBA    979-774-5933    jscott@js-studies.com   
Principal Investigator: Terry Jones, MD         
Sponsors and Collaborators
AmDerma
  More Information

No publications provided

Responsible Party: AmDerma
ClinicalTrials.gov Identifier: NCT01938599     History of Changes
Other Study ID Numbers: AD-AM001-001
Study First Received: September 5, 2013
Last Updated: September 5, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by AmDerma:
Plaque Psoriasis

Additional relevant MeSH terms:
Psoriasis
Skin Diseases
Skin Diseases, Papulosquamous

ClinicalTrials.gov processed this record on April 15, 2014