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

Plaque Psoriasis Clinical Trial

Official title:

A Multi-Center, Double-Blind, Randomized, Vehicle-Controlled, Parallel-Group Study Comparing AM001 Cream to Vehicle in the Treatment of Plaque Psoriasis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01938599
• Other study ID #: AD-AM001-001
• Status: Completed
• Phase: Phase 2
• First received: September 5, 2013
• Last updated: November 30, 2016
• Start date: August 2013
• Est. completion date: August 2014

Study information

• Verified date: November 2016
• Source: AmDerma
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 92
• Est. completion date: August 2014
• Est. primary completion date: May 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Plaque Psoriasis
• Psoriasis
• Skin Diseases
• Skin Diseases, Papulosquamous

Intervention

Drug:
• AM001 Cream, 7.5%
Cream, 2x daily for 12 weeks
• Placebo of AM001 Cream
Cream, 2x daily for 12 weeks

Locations

Country	Name	City	State
United States	Academic Dermatology Association	Albuquerque	New Mexico
United States	J & S Studies	College Station	Texas
United States	Minnesota Clinical Study Center	Fridley	Minnesota
United States	Dermatology Consulting Services	High Point	North Carolina
United States	International Dermatology Research, Inc.	Miami	Florida

Sponsors (1)

Lead Sponsor	Collaborator
AmDerma

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Investigator's Global Assessment of Disease Severity (IGA)	An overall assessment of disease severity will be performed at each study visit.	Week 12	No
Secondary	Target Lesion Psoriasis Area Severity Index (PASI)	Erythema, Scaling and Plaque Elevation of the target lesion will be scored at baseline and at each subsequent study visit.	12 Weeks	No
Secondary	Body Surface Area (BSA)	The % BSA of all treatable psoriatic lesions and regions will be recorded at baseline and at week 12.	12 Weeks	No
Secondary	Target Lesion Area	The target lesion area will be measured at baseline and each-post-baseline visit.	12 Weeks	No
Secondary	Dermatology Life Quality Index (DLQI)	Measured at baseline and week 12.	12 Weeks	No
Secondary	Pharmacokinetics	Systemic absorption will be determined in a subgroup.	2 Weeks	Yes