Psoriasis
Conditions
Brief 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.
Interventions
DRUGMetaderm
Metaderm cream and spray will be apply to subjects scalp and body.
Sponsors
University of Alabama at Birmingham
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
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
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy as Measured by the Mean Percentage Change in the Product of Static Physician Global Assessment (sPGA) and Body Surface Area (BSA). | Baseline to Week 12 | The sPGA is the physician's global assessment of the subjects plaque psoriasis at a given time point. Plaques are assessed for induration, erythema, and scaling and an overall rating of plaque psoriasis severity is gen using the anchors of clear (0), minimal (1), mild (2), moderate (3), severe (4), or very severe (5). The BSA is the amount of body surface area affected by a disease. In this, the head represents 10% of the body, the upper extremities 20%, the trunk 30%, and the lower extremities 40%. These assessments will be combined by multiplying the numerical outcomes of the sPGA and BSA assessments to form a result. The mean change in this result will then be reported as the efficacy outcome. The data was all inclusive and not divided out by arm. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy as Measured by the Percentage Change in the DLQI. (Dermatology Quality of Life Index). | Baseline to Week 12 | The dermatology quality of life index (DLQI) is a simple, subject administered, 10 question validated, quality of life questionnaire that cover 6 domains including symptoms and feelings, daily activities, leisure, work, and school, personal relationships, and treatment. Response categories include not at all, a lot, and very much, with corresponding score of 1, 2, and 3, respectively, and unanswered (not relevant) responses scored as 0. The recall period is over the last week, totals range from 0 to 30 (less to more impairment), and a 5-point change from baseline is considered clinically relevant. The data was all inclusive and not divided out by arm. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Nonsystemic Therapy + Herbal Anti-Inflammatory Treatment (HAT1) Participants who received HAT1 treatment and were not on systemic treatment at time of enrollment | 6 |
| Systemic Therapy + Herbal Anti-Inflammatory Treatment (HAT1) Participants who received HAT1 treatment and were on systemic treatment at time of enrollment | 5 |
| Total | 11 |
Baseline characteristics
| Characteristic | Nonsystemic Therapy + Herbal Anti-Inflammatory Treatment (HAT1) | Systemic Therapy + Herbal Anti-Inflammatory Treatment (HAT1) | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 2 Participants | 3 Participants | 5 Participants |
| Age, Categorical Between 18 and 65 years | 4 Participants | 2 Participants | 6 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 6 Participants | 5 Participants | 11 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 5 Participants | 5 Participants | 10 Participants |
| Region of Enrollment United States | 6 Participants | 5 Participants | 11 Participants |
| Sex: Female, Male Female | 5 Participants | 3 Participants | 8 Participants |
| Sex: Female, Male Male | 1 Participants | 2 Participants | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 6 | 0 / 5 |
| other Total, other adverse events | 0 / 6 | 0 / 5 |
| serious Total, serious adverse events | 0 / 6 | 0 / 5 |
Outcome results
Primary
Efficacy as Measured by the Mean Percentage Change in the Product of Static Physician Global Assessment (sPGA) and Body Surface Area (BSA).
The sPGA is the physician's global assessment of the subjects plaque psoriasis at a given time point. Plaques are assessed for induration, erythema, and scaling and an overall rating of plaque psoriasis severity is gen using the anchors of clear (0), minimal (1), mild (2), moderate (3), severe (4), or very severe (5). The BSA is the amount of body surface area affected by a disease. In this, the head represents 10% of the body, the upper extremities 20%, the trunk 30%, and the lower extremities 40%. These assessments will be combined by multiplying the numerical outcomes of the sPGA and BSA assessments to form a result. The mean change in this result will then be reported as the efficacy outcome. The data was all inclusive and not divided out by arm.
Time frame: Baseline to Week 12
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Nonsystemic Therapy+ Herbal Anti-Inflammatory Treatment (HAT1) | Efficacy as Measured by the Mean Percentage Change in the Product of Static Physician Global Assessment (sPGA) and Body Surface Area (BSA). | 53.06 percentage of change in sPGAxBSAscore | Standard Deviation 40.01 |
| Systemic Therapy + Herbal Anti-Inflammatory Treatment (HAT1) | Efficacy as Measured by the Mean Percentage Change in the Product of Static Physician Global Assessment (sPGA) and Body Surface Area (BSA). | 65.6 percentage of change in sPGAxBSAscore | Standard Deviation 19.4 |
Secondary
Efficacy as Measured by the Percentage Change in the DLQI. (Dermatology Quality of Life Index).
The dermatology quality of life index (DLQI) is a simple, subject administered, 10 question validated, quality of life questionnaire that cover 6 domains including symptoms and feelings, daily activities, leisure, work, and school, personal relationships, and treatment. Response categories include not at all, a lot, and very much, with corresponding score of 1, 2, and 3, respectively, and unanswered (not relevant) responses scored as 0. The recall period is over the last week, totals range from 0 to 30 (less to more impairment), and a 5-point change from baseline is considered clinically relevant. The data was all inclusive and not divided out by arm.
Time frame: Baseline to Week 12
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Nonsystemic Therapy+ Herbal Anti-Inflammatory Treatment (HAT1) | Efficacy as Measured by the Percentage Change in the DLQI. (Dermatology Quality of Life Index). | 52.88 percentage change for DLQI | Standard Deviation 45.66 |
| Systemic Therapy + Herbal Anti-Inflammatory Treatment (HAT1) | Efficacy as Measured by the Percentage Change in the DLQI. (Dermatology Quality of Life Index). | 17.82 percentage change for DLQI | Standard Deviation 36.68 |