ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 51 of 90 for:    cream | "Psoriasis"

Evaluating the Efficacy and Tolerability of Application of Metaderm Product for the Treatment of Psoriasis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03597620
Recruitment Status : Not yet recruiting
First Posted : July 24, 2018
Last Update Posted : July 24, 2018
Sponsor:
Information provided by (Responsible Party):
Boni Elewski, MD, University of Alabama at Birmingham

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.

Condition or disease Intervention/treatment Phase
Psoriasis Drug: Metaderm Phase 4

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Allocation: Non-Randomized
Intervention Model: Single Group 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 the subgroup for scalp psoriasis, patient will use the shampoo Head & Shoulders formula with 1% Pyrithione Zinc as the active ingredient
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Investigator Initiated Open Label Study Evaluating the Efficacy and Tolerability of Application of Metaderm Product for the Treatment of Psoriasis
Estimated Study Start Date : October 2018
Estimated Primary Completion Date : October 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis

Arm Intervention/treatment
Experimental: Patients with plaque psoriasis 3-10% BSA
Metaderm cream will be applied topically twice a day to all active lesions.
Drug: Metaderm
Metaderm cream and spray will be apply to subjects scalp and body.

Experimental: Patients with stable dose of biologic treatment & 3-10% BSA
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.
Drug: Metaderm
Metaderm cream and spray will be apply to subjects scalp and body.

Experimental: Patients with Scalp Psoriasis
For the subgroup for scalp psoriasis, patient will use the shampoo Head & Shoulders formula with 1% Pyrithione Zinc as the active ingredient
Drug: Metaderm
Metaderm cream and spray will be apply to subjects scalp and body.




Primary Outcome Measures :
  1. Efficacy as measured by the mean percentage change in the product of sPGA (static physician global assessment) and BSA (body surface area). [ Time Frame: Baseline to Week 12 ]

    The PASI is primary efficacy measurement for treatment of plaque psoriasis. The PASI combines assessments of the extent of body-surface involvement in 4 anatomical regions (head and neck, trunk, arms, and legs) and the severity of scaling, redness, and plaque induration/infiltration (thickness) in each region, yielding an overall score of 0 for no plaque psoriasis and 72 for the most severe disease.

    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).

    These assessments will be combined by multiplying the numerical outcomes of the SPGA and BSA assessments to form a product. The mean change in this product will then be reported as the efficacy outcome.



Secondary Outcome Measures :
  1. Efficacy as measured by the percentage improvement in the DLQI. (Dermatology quality of life index). [ Time Frame: 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03597620


Contacts
Contact: Leslie Roop 2059754917 lmroop@uabmc.edu

Sponsors and Collaborators
University of Alabama at Birmingham
Investigators
Principal Investigator: Boni Elewski, MD University of Alabama at Birmingham

Responsible Party: Boni Elewski, MD, Profesor and Chair, Department of Dermatology, University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT03597620     History of Changes
Other Study ID Numbers: 180530
First Posted: July 24, 2018    Key Record Dates
Last Update Posted: July 24, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases