PsoriasisPhase 4NCT03597620
Evaluating the Efficacy and Tolerability of Application of Metaderm Product for the Treatment of Psoriasis
A Phase 4 study testing Metaderm in people with Psoriasis, run by University of Alabama at Birmingham at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Psoriasis
- What is being tested?
- Metaderm
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Nov 2018to 13 Dec 2022
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- Plaque psoriasis involving the scalp
- Body plaque psoriasis cannot exceed 10 %BSA
- 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).
Who cannot join
- The presence of any of the following will exclude a subject from enrollment:
- 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.
- 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.
- 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.
- Pregnant or breast feeding.
- Active substance abuse or a history of substance abuse within 6 months prior to Screening.
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- Use of any investigational drug within 4 weeks prior to randomization, or 5 pharmacokinetic/pharmacodynamic half lives, if known (whichever is longer).
- Prior treatment with the investigational product
- Unable to comply with the protocol (as defined by the Investigator; i.e. drug or alcohol abuse or history of noncompliance)
- Any other dermatologic conditions that prohibit or confound the ability of the investigator to interpret skin and/or nail exam findings.
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Dermatology at the Whitaker Clinic
Birmingham, Alabama, 35249
About this study
Official title: An Investigator Initiated Open Label Study Evaluating the Efficacy and Tolerability of Application of Metaderm Product for the Treatment of Psoriasis
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.
- Conditions
- Psoriasis
- Being tested
- Metaderm
- Medical subject headings
- Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MetadermDrug
Metaderm cream and spray will be apply to subjects scalp and body.
| Study group | Role | What they receive |
|---|---|---|
| Nonsystemic Therapy + Herbal Anti-Inflammatory Treatment (HAT1) | Experimental | Patients who received HAT1 and were not on systemic treatment at time of enrollment. 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. Receives: Drug: Metaderm |
| Systemic Therapy + Herbal Anti-Inflammatory Treatment (HAT1) | Experimental | Patients who received HAT1 and were on systemic treatment at time of enrollment. 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. Receives: Drug: Metaderm |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline to Week 12
Secondary outcomes (1)
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.
Measured: Baseline to Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2018
- Study start7 Nov 2018
- Primary completion31 Oct 2020
- Study completion13 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for PsoriasisStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Boni Elewski, University of Alabama at Birmingham
- Investigators
- Boni Elewski, MD, Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03597620
- Sponsor's protocol ID
- 180530
- Status last verified
- Dec 2023
- First submitted
- 9 Jul 2018
- Last updated
- 15 Dec 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Investigator Initiated Open Label Study Evaluating the Efficacy and Tolerability of Application of Metaderm Product for the Treatment of Psoriasis
- ClinicalTrials.gov ID
- NCT03597620
- Acronym / sponsor ID
- 180530
- Conditions
- Psoriasis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Study start
- 7 Nov 2018 (actual)
- Primary completion
- 31 Oct 2020 (actual)
- Study completion
- 13 Dec 2022 (actual)
- First posted
- 24 Jul 2018 (actual)
- Results
- Posted 3 Oct 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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
| Arm | Type | Receives |
|---|---|---|
| Nonsystemic Therapy + Herbal Anti-Inflammatory Treatment (HAT1) | Experimental | Drug: MetadermPatients who received HAT1 and were not on systemic treatment at time of enrollment. 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. |
| Systemic Therapy + Herbal Anti-Inflammatory Treatment (HAT1) | Experimental | Drug: MetadermPatients who received HAT1 and were on systemic treatment at time of enrollment. 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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
Key exclusion criteria (11 listed)
- 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.
- 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.
- 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.
- Pregnant or breast feeding.
- Active substance abuse or a history of substance abuse within 6 months prior to Screening.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MetadermMetaderm cream and spray will be apply to subjects scalp and body. | Drug | Nonsystemic Therapy + Herbal Anti-Inflammatory Treatment (HAT1), Systemic Therapy + Herbal Anti-Inflammatory Treatment (HAT1) |
Primary outcome
Efficacy as Measured by the Mean Percentage Change in the Product of Static Physician Global Assessment (sPGA) and Body Surface Area (BSA).
Time frame: 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.
1 secondary outcome
Efficacy as Measured by the Percentage Change in the DLQI. (Dermatology Quality of Life Index).
Time frame: Baseline to Week 12
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Boni Elewski, MD principal investigator
University of Alabama at Birmingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Metaderm in people with Psoriasis, run by University of Alabama at Birmingham at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 3 Oct 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy as Measured by the Mean Percentage Change in the Product of Static Physician Global Assessment (sPGA) and Body Surface Area (BSA). (time frame: Baseline to Week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Dec 2023.