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

NCT01938599 | Completed Phase 2

• 1 other identifier: AD-AM001-001
• Study Type: interventional
• Target: 92
• Locations: 1 country
• Sites: 5

Brief Summary

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

Conditions

Plaque Psoriasis; Skin Diseases, Papulosquamous; Skin Diseases

Keywords

Plaque Psoriasis

Outcome Measures

Primary Outcomes (1)

• Investigator's Global Assessment of Disease Severity (IGA)

  An overall assessment of disease severity will be performed at each study visit.

  Week 12

Secondary Outcomes (5)

• Target Lesion Psoriasis Area Severity Index (PASI)

  12 Weeks

• Body Surface Area (BSA)

  12 Weeks

• Target Lesion Area

  12 Weeks

• Dermatology Life Quality Index (DLQI)

  12 Weeks

• Pharmacokinetics

  2 Weeks

Study Arms (2)

AM001

EXPERIMENTAL

AM001 Cream, 7.5%. 2x daily for 12 weeks.

Drug: AM001 Cream, 7.5%

Vehicle

PLACEBO COMPARATOR

Placebo of AM001 Cream. 2x daily for 12 weeks.

Drug: Placebo of AM001 Cream

Interventions

AM001 Cream, 7.5% DRUG

Cream, 2x daily for 12 weeks

AM001

Placebo of AM001 Cream DRUG

Cream, 2x daily for 12 weeks

Vehicle

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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 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.

Sponsors & Collaborators

• AmDerma: lead

Study Sites (5)

International Dermatology Research, Inc.

Miami, Florida, 33144, United States

Location

Minnesota Clinical Study Center

Fridley, Minnesota, 55432, United States

Location

Academic Dermatology Association

Albuquerque, New Mexico, 87106, United States

Location

Dermatology Consulting Services

High Point, North Carolina, 27262, United States

Location

J & S Studies

College Station, Texas, 77845, United States

Location

MeSH Terms

Conditions

Skin Diseases, Papulosquamous; Skin Diseases

Condition Hierarchy (Ancestors)

Skin and Connective Tissue Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 5, 2013
• First Posted: September 10, 2013
• Study Start: August 1, 2013
• Primary Completion: May 1, 2014
• Study Completion: August 1, 2014
• Last Updated: December 1, 2016

Record last verified: 2016-11

Locations

US (5)