A double blind, randomized, parallel group study to evaluate efficacy and safety of NGP-01 gel against placebo in the treatment of mild to moderate Psoriasis
Trial Snapshot
- Phase
- Phase 2/3
- Status
- Recruiting
- Sponsor
- Nutrin GmbH
- Enrollment
- 60
- Locations
- 2
- Primary Endpoint
- Percentage of subjects achieving at least a 1-grade improvement in Physician’s Global Assessment (PGA) score
Study Overview
Brief Summary
Psoriasis is a common, immune-mediated, inflammatory skin disease that is found world-
wide. The prevalence of diagnosed psoriasis in the United States (US) is approximately 3% whereas the prevalence in Europe varies anywhere from 0.6 to 6.5% with an average of
approximately 3%. The clinical course is unpredictable, but in most cases, psoriasis is a chronically remitting and relapsing disease. Chronic stable plaque psoriasis (psoriasis vulgaris) is the most common form of the disease, accounting for 85-90 % of cases. Plaque- type psoriasis or psoriasis vulgaris is the most common form of the disease, and manifests as
raised, red, scaly patches with silver scales. The lesions are usually distributed symmetrically, and occur most commonly on the extensor parts of elbows and knees; scalp, lumbosacral region and umbilicus. Patients with psoriasis have reduced quality of life with reduced levels of employment and income, and studies have shown that patients with psoriasis are emotionally and physically impaired by their disease comparable to that seen with cancer,
heart disease, rheumatoid arthritis, diabetes or depression.
Individuals with psoriasis appear to be at an elevated risk of developing other chronic and
serious health conditions, such as metabolic syndrome/type 2 diabetes, cardiovascular
disease, psoriatic arthritis and other chronic inflammatory diseases.
There is no cure for psoriasis. The goal of treatment is to reduce or eliminate its signs and
symptoms. Mild to moderate disease is often treated with topical therapies. Sponsor has
developed the NGP-01 Gel containing the fixed dose combination of Dead Sea Salt,
Ethanol/water, Panthenol, Tocopheryl Acetate, Hydroxyethylcellulose, Isopropyl Myristate,
Retinyl Palmitate, Glycerin F, Aloe Barbadensis Leaf, Citric acid, without preservatives and
dyes. The Gel is easy to apply, and the cosmetic appearance is that of a white, milky gel,
easily-spreadable that absorbs completely into the skin a few minutes after application and it
is expected that the Gel will differentiate from marketed formulations by patient preference
for the gel and gel.
Study Design
- Study Type
- Interventional
- Allocation
- Computer generated randomization
- Masking
- Participant and Investigator Blinded
Eligibility Criteria
- Ages
- 18.00 Year(s) to 65.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Are ≥18 to ≤65 years of age
- •Have a clinical diagnosis of mild-to-moderate plaque psoriasis, as defined by a Psoriasis Area and Severity Index (PASI) score between 2 and 12, appropriate for topical treatment that covers a minimum of 1.0% and a maximum of 10% Body Surface Area (BSA), in the permitted treatment areas.
- •Are willing to treat all psoriasis occurring in the permitted treatment areas with only NGP-01 gel
- •Are free of any systemic or dermatologic disorder, which, in the opinion of the investigator, will interfere with the study results or increase the risk of adverse events.
- •Are willing to avoid prolonged exposure of the treatment area to ultraviolet radiation (natural or artificial) for the duration of the study.
- •Are willing to refrain from using any lotions, moisturizer, cleansers, cosmetics or creams, other than those issued as part of the study, on the treatment areas during the treatment period.
- •If female of childbearing potential, must be willing to practice an acceptable form of birth control for the duration of the study.
- •Are able to give written informed consent in a manner approved by the Institutional Ethics Committee and comply with the requirements of the study.
- •Are willing to avoid participation in any other interventional clinical trial for the duration of this study.
- •Are willing to refrain from treating restricted areas, which will be excluded from the PGA assessments and Body Surface Area (BSA) calculation.
- •These areas are as follows: head, neck, fingernails, toenails, soles of feet, and palms of hands, axillae, or intertriginous areas.
Exclusion Criteria
- •Have spontaneously improving or rapidly deteriorating plaque psoriasis, or pustular psoriasis as determined by the Investigator.
- •Have been treated, with prescription medication for plaque psoriasis, with no improvement in condition, within 60 days prior to the Baseline visit.
- •Are pregnant, breast-feeding, or planning to become pregnant during the study.
- •Have any evidence of systemic cancer, squamous cell carcinoma, basal cell carcinoma, in the last 5 years, or any other confounding skin condition.
- •Are undergoing treatments with topical antipsoriatic drug products other than corticosteroids within 14 days prior to the Baseline Visit, and for therapy containing corticosteroids or retinoids within 28 days prior to Baseline Visit.
- •Have open sores or open lesions in the treatment area(s).
- •Have any condition that, in the opinion of the investigator, would confound the safety and/or efficacy assessments of plaque psoriasis.
- •Have participated in any interventional clinical trial in the previous 30 days.
- •Have a known sensitivity to any of the constituents of the test product including sensitivities to sandalwood oil, fragrances, or any member of the Compositae family of vascular plants (e.g., sunflowers, daisies, dahlias, etc.).
- •Have used, are using, or are planning to use immunosuppressive or immunomodulatory medication (i.e., biologics), including oral or parenteral corticosteroids.
- •Have a history of alcohol or illegal drug/substance abuse, or suspected alcohol or illegal drug/substance abuse in the past 2 years.
- •Plan to seek alternative treatment of any kind for their psoriasis, in the eligible treatment areas or otherwise, during the trial period.
Outcomes
Primary Outcomes
Percentage of subjects achieving at least a 1-grade improvement in Physician’s Global Assessment (PGA) score
Time Frame: Baseline to Day 90
Secondary Outcomes
- Percentage of subjects achieving a 2-grade improvement in the Physician’s Global Assessment (PGA) score(Baseline to Day 90)
- Percentage of subjects who have a ≥ 25% reduction in the Psoriasis Area and Severity Index (PASI) score at any point during the trial.(Baseline to Day 90)
- Number of subjects achieving a Physician’s Global Assessment of “clear†or “almost clearâ€(Baseline to Day 90)
- Percentage of subjects who have a ≥50% reduction in the Psoriasis Area Severity Index (PASI) score at any point during the trial.(Baseline to Day 90)
- To assess the duration of treatment at intermediate & end point of treatment.(Baseline to Day 90)
- To assess the safety and tolerability.(Baseline to Day 90)