Evaluating the Efficacy and Tolerability of Application of Metaderm Product for the Treatment of Psoriasis
| Status: | Recruiting |
|---|---|
| Conditions: | Psoriasis |
| Therapuetic Areas: | Dermatology / Plastic Surgery |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 12/8/2018 |
| Start Date: | November 7, 2018 |
| End Date: | December 2019 |
| Contact: | Leslie Roop |
| Email: | lmroop@uabmc.edu |
| Phone: | 2059754917 |
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.
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.
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
We found this trial at
1
site
Birmingham, Alabama 35249
Principal Investigator: Boni E Elewski, MD
Phone: 205-502-9962
Click here to add this to my saved trials
