Phase 4
N=11
Evaluating the Efficacy and Tolerability of Application of Metaderm Product for the Treatment of Psoriasis
Psoriasis
Bottom Line
View on ClinicalTrials.gov: NCT03597620 ↗Enrolled (actual)
11
Serious AEs
0.0%
Results posted
Oct 2022
Primary outcome: Primary: Efficacy as Measured by the Mean Percentage Change in the Product of Static Physician Global Assessment (sPGA) and Body Surface Area (BSA). — 53.06; 65.6 percentage of change in sPGAxBSAscore
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Metaderm (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Alabama at Birmingham
- Primary completion
- Oct 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Efficacy as Measured by the Mean Percentage Change in the Product of Static Physician Global Assessment (sPGA) and Body Surface Area (BSA). |
53.06; 65.6 | — |
| SECONDARY Efficacy as Measured by the Percentage Change in the DLQI. (Dermatology Quality of Life Index). |
52.88; 17.82 | — |
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:
- 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).
- Patients 18 and older
- Give written informed consent prior to any study procedures being conducted, and candidates will authorize the release and use of protected health information (PHI)
- Be willing and consent to having photos taken of their skin
- Diagnosis of chronic plaque psoriasis that has been present for at least 6 months prior to baseline
- Plaque psoriasis involving at least 3-10% of the patient's body surface area
- 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
- Must have discontinued all topical therapies for the treatment of psoriasis at least 2 weeks prior to baseline visit
- Subjects must have discontinued UV therapy at least 2 weeks prior to baseline and PUVA at least 4 weeks prior to baseline.
- 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.
- 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:
- 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).
- Patients 18 and older
- Give written informed consent prior to any study procedures being conducted, and candidates will authorize the release and use of protected health information (PHI)
- Be willing and consent to having photos taken of their skin
- Diagnosis of chronic plaque psoriasis that has been present for at least 6 months prior to baseline
- Stable dose of biologic therapy for the last 6 months prior to screening visit
- Plaque psoriasis involving at least 3-10% of the patient's body surface area
- Must have discontinued all topical therapies for the treatment of psoriasis at least 2 weeks prior to baseline visit
- Subjects must have discontinued UV therapy at least 2 weeks prior to baseline and PUVA at least 4 weeks prior to baseline.
- 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.
- Females of childbearing potential mus
Data sourced from ClinicalTrials.gov (NCT03597620). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.