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

Phase 4

Completed

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.

Recruitment & Eligibility

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Arm && Interventions

Group	Intervention	Description
Nonsystemic Therapy + Herbal Anti-Inflammatory Treatment (HAT1)	Metaderm	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.
Systemic Therapy + Herbal Anti-Inflammatory Treatment (HAT1)	Metaderm	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Locations (1): Dermatology at the Whitaker Clinic
🇺🇸
Birmingham, Alabama, United States
Dermatology at the Whitaker Clinic
🇺🇸Birmingham, Alabama, United States