Evaluating the Efficacy and Tolerability of Application of Metaderm Product for the Treatment of Psoriasis
Condition: Psoriasis
MeSH terms: Psoriasis
Intervention: Metaderm
Intervention description: Metaderm cream and spray will be apply to subjects scalp and body.
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: 15 eligible patients will be enrolled. Patient will be treated for 12 weeks. There will be a total of five visits: screening, baseline, w4, w8 and w12. Metaderm cream will be applied topically twice a day to all active lesions. The metaderm scalp spray will be applied daily to the affected areas on the scalp. Patients will be provided with metaderm cleanser, can be use daily. For scalp psoriasis, patient will also use the shampoo Head & Shoulders formula with 1% Pyrithione Zinc as the active ingredient
Masking: None (Open Label)
Enrollment: 11.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      Psoriasis vulgaris is a common inflammatory condition of the skin that results in
      well-demarcated, scaly, erythematous, itchy plaques. In the United States, psoriasis remains
      a common, immune-mediated disease, affecting 7.4 million adults. Often topical prescription
      medications are used as first line treatment for moderate psoriasis. Some topical medications
      have side effects and risk with long time use, thus not ideal for extensive and indefinite
      amount of time. Conversely, over- the-counter emollient treatments are readily available,
      safe and potentially efficacious. This study is design to test the safety and efficacy of
      topical application of the Metaderm product cream. The Metaderm cream is non-prescription,
      natural product.
    

Eligibility criteria:

        Inclusion Criteria for patients with plaque psoriasis 3-10% BSA

        Subjects must satisfy the following criteria to be enrolled in the study:

          1. Must be in general good health (except for disease under study) as judged by the
             Investigator, based on medical history, physical examination, clinical laboratories,
             and urinalysis. (NOTE: The definition of good health means a subject does not have
             uncontrolled significant co-morbid conditions).

          2. Patients 18 and older

          3. Give written informed consent prior to any study procedures being conducted, and
             candidates will authorize the release and use of protected health information (PHI)

          4. Be willing and consent to having photos taken of their skin

          5. Diagnosis of chronic plaque psoriasis that has been present for at least 6 months
             prior to baseline

          6. Plaque psoriasis involving at least 3-10% of the patient's body surface area

          7. Must have discontinued all systemic therapies for the treatment of psoriasis or
             psoriatic arthritis at least 4 weeks or 5 half-lives, and biologics 6 months) prior to
             baseline visit

          8. Must have discontinued all topical therapies for the treatment of psoriasis at least 2
             weeks prior to baseline visit

          9. Subjects must have discontinued UV therapy at least 2 weeks prior to baseline and PUVA
             at least 4 weeks prior to baseline.

         10. Subjects must be in good general health without significant uncontrolled
             comorbidities, other than psoriasis, as determined by the investigator based on exam
             findings, medical history, and clinical laboratories. Patients with stable mild renal
             insufficiency are eligible for enrolling in this trial.

         11. Females of childbearing potential must use an approved birth control method while
             receiving treatment and for 28 days following the investigational product and there
             must be a documented negative pregnancy tests prior to initiating treatment. Approved
             birth control methods include hormonal contraception (oral, injection, implant,
             transdermal patch, vaginal ring), intrauterine device, tubal ligation (tying your
             tubes), partners vasectomy, or male or female condoms that are not made of natural
             materials PLUS a diaphragm with spermicide, cervical cap with spermicide, or a
             contraceptive sponge with spermicide. Females not of child bearing potential are
             defined as being at least 1 year postmenopausal or surgically sterile (bilateral tubal
             ligation, bilateral oophorectomy and/or hysterectomy).

        Inclusion Criteria with stable dose of biologic treatment and have plaque psoriasis 3-10
        %BSA

        Subjects must satisfy the following criteria to be enrolled in the study:

          1. Must be in general good health (except for disease under study) as judged by the
             Investigator, based on medical history, physical examination, clinical laboratories,
             and urinalysis. (NOTE: The definition of good health means a subject does not have
             uncontrolled significant co-morbid conditions).

          2. Patients 18 and older

          3. Give written informed consent prior to any study procedures being conducted, and
             candidates will authorize the release and use of protected health information (PHI)

          4. Be willing and consent to having photos taken of their skin

          5. Diagnosis of chronic plaque psoriasis that has been present for at least 6 months
             prior to baseline

          6. Stable dose of biologic therapy for the last 6 months prior to screening visit

          7. Plaque psoriasis involving at least 3-10% of the patient's body surface area

          8. Must have discontinued all topical therapies for the treatment of psoriasis at least 2
             weeks prior to baseline visit

          9. Subjects must have discontinued UV therapy at least 2 weeks prior to baseline and PUVA
             at least 4 weeks prior to baseline.

         10. Subjects must be in good general health without significant uncontrolled
             comorbidities, other than psoriasis, as determined by the investigator based on exam
             findings, medical history, and clinical laboratories. Patients with stable mild renal
             insufficiency are eligible for enrolling in this trial.

         11. Females of childbearing potential must use an approved birth control method while
             receiving treatment and for 28 days following the investigational product and there
             must be a documented negative pregnancy tests prior to initiating treatment. Approved
             birth control methods include hormonal contraception (oral, injection, implant,
             transdermal patch, vaginal ring), intrauterine device, tubal ligation (tying your
             tubes), partners vasectomy, or male or female condoms that are not made of natural
             materials PLUS a diaphragm with spermicide, cervical cap with spermicide, or a
             contraceptive sponge with spermicide. Females not of child bearing potential are
             defined as being at least 1 year postmenopausal or surgically sterile (bilateral tubal
             ligation, bilateral oophorectomy and/or hysterectomy).

        Inclusion Criteria for patients with scalp psoriasis

        Subjects must satisfy the following criteria to be enrolled in the study:

          1. Must be in general good health (except for disease under study) as judged by the
             Investigator, based on medical history, physical examination, clinical laboratories,
             and urinalysis. (NOTE: The definition of good health means a subject does not have
             uncontrolled significant co-morbid conditions).

          2. Patients 18 and older

          3. Give written informed consent prior to any study procedures being conducted, and
             candidates will authorize the release and use of protected health information (PHI)

          4. Be willing and consent to having photos taken of their skin

          5. Diagnosis of chronic plaque psoriasis that has been present for at least 6 months
             prior to baseline

          6. Plaque psoriasis involving the scalp

          7. Body plaque psoriasis cannot exceed 10 %BSA

          8. Must have discontinued all systemic therapies for the treatment of psoriasis or
             psoriatic arthritis at least 4 weeks or 5 half-lives, and biologics 6 months) prior to
             baseline visit

          9. Must have discontinued all topical therapies for the treatment of psoriasis at least 2
             weeks prior to baseline visit

         10. Subjects must have discontinued UV therapy at least 2 weeks prior to baseline and PUVA
             at least 4 weeks prior to baseline.

         11. Subjects must be in good general health without significant uncontrolled
             comorbidities, other than psoriasis, as determined by the investigator based on exam
             findings, medical history, and clinical laboratories. Patients with stable mild renal
             insufficiency are eligible for enrolling in this trial.

         12. Females of childbearing potential must use an approved birth control method while
             receiving treatment and for 28 days following the investigational product and there
             must be a documented negative pregnancy tests prior to initiating treatment. Approved
             birth control methods include hormonal contraception (oral, injection, implant,
             transdermal patch, vaginal ring), intrauterine device, tubal ligation (tying your
             tubes), partners vasectomy, or male or female condoms that are not made of natural
             materials PLUS a diaphragm with spermicide, cervical cap with spermicide, or a
             contraceptive sponge with spermicide. Females not of child bearing potential are
             defined as being at least 1 year postmenopausal or surgically sterile (bilateral tubal
             ligation, bilateral oophorectomy and/or hysterectomy).

             Exclusion Criteria

             The presence of any of the following will exclude a subject from enrollment:

         13. Other than disease under study, any clinically significant (as determined by the
             Investigator) cardiac, endocrinologic, pulmonary, neurologic, psychiatric, hepatic,
             renal, hematologic, immunologic disease, or other major disease that is currently
             uncontrolled.

         14. Any condition, including the presence of laboratory abnormalities, which would place
             the subject at unacceptable risk if he/she were to participate in the study.

         15. Prior history of suicide attempt at any time in the subject's life time prior to
             screening or randomization, or major psychiatric illness requiring hospitalization
             within the last 3 years.

         16. Pregnant or breast feeding.

         17. Active substance abuse or a history of substance abuse within 6 months prior to
             Screening.

         18. Use of any investigational drug within 4 weeks prior to randomization, or 5
             pharmacokinetic/pharmacodynamic half lives, if known (whichever is longer).

         19. Prior treatment with the investigational product

         20. Unable to comply with the protocol (as defined by the Investigator; i.e. drug or
             alcohol abuse or history of noncompliance)

         21. Any other dermatologic conditions that prohibit or confound the ability of the
             investigator to interpret skin and/or nail exam findings.

         22. Patients who will be unable to avoid the use of systemic steroids, excluding
             intranasal or inhaled steroids that will be permitted, for the duration of the trial