1 Ocak 2023 Dergi makalesi Açık Erişim

Sezer, Zafer; Inal, Ahmet; Cinar, Salih L.; Mazicioglu, Mustafa M.; Altug, Sedat; Karasulu, Hatice Y.; Diril, Mine; Mehmetoglu, Al Ayca; Kozlu, Serhat; Ulu, Nadir

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{
  "@context": "https://schema.org/", 
  "@id": 272908, 
  "@type": "ScholarlyArticle", 
  "creator": [
    {
      "@type": "Person", 
      "name": "Sezer, Zafer"
    }, 
    {
      "@type": "Person", 
      "name": "Inal, Ahmet"
    }, 
    {
      "@type": "Person", 
      "affiliation": "Erciyes Univ, Fac Med, Dept Dermatol, Kayseri, Turkiye", 
      "name": "Cinar, Salih L."
    }, 
    {
      "@type": "Person", 
      "affiliation": "Erciyes Univ, Fac Med, Dept Family Med, Kayseri, Turkiye", 
      "name": "Mazicioglu, Mustafa M."
    }, 
    {
      "@type": "Person", 
      "affiliation": "Demiroglu Bilim Univ, Fac Med, Dept Pharmacol, Istanbul, Turkiye", 
      "name": "Altug, Sedat"
    }, 
    {
      "@type": "Person", 
      "name": "Karasulu, Hatice Y."
    }, 
    {
      "@type": "Person", 
      "affiliation": "Sedef Ilac & Med Urunleri Ind Trade Co Ltd, Dept Res & Dev, Kastamonu, Turkiye", 
      "name": "Diril, Mine"
    }, 
    {
      "@type": "Person", 
      "affiliation": "Sedef Ilac & Med Urunleri Ind Trade Co Ltd, Dept Res & Dev, Kastamonu, Turkiye", 
      "name": "Mehmetoglu, Al Ayca"
    }, 
    {
      "@type": "Person", 
      "affiliation": "Gen Ilac & Saglik Urunleri AS, Dept Res & Dev, ASO 2 & 3 Organize Sanayi Bolgesi, Alci OSB Mahall, TR-06930 Ankara, Turkiye", 
      "name": "Kozlu, Serhat"
    }, 
    {
      "@type": "Person", 
      "affiliation": "Gen Ilac & Saglik Urunleri AS, Dept Res & Dev, ASO 2 & 3 Organize Sanayi Bolgesi, Alci OSB Mahall, TR-06930 Ankara, Turkiye", 
      "name": "Ulu, Nadir"
    }
  ], 
  "datePublished": "2023-01-01", 
  "description": "<p>IntroductionPsoriasis is a common skin disorder associated with physical and psychological burdens. Visible disfiguration can trigger a negative reaction which can cause much of the readily measurable psychological burden of the disease. Although many biological treatments provide some success in the initial clearance of lesions, there is a dispute about the long-term maintenance of the disease, as no current biological treatment has been shown to be curative. Topical therapies are still the most widely used agents as first-line and maintenance treatment for psoriasis. The present study aimed to investigate the safety, tolerability, and, to some extent, efficacy of GN-037 cream in patients with psoriasis and healthy volunteers.MethodsA randomized, double-blind, single-center, placebo-controlled phase 1 clinical study was conducted to evaluate the safety, tolerability, and clinical efficacy of GN-037 cream topically applied twice daily for 2 weeks in healthy subjects (n = 12) and patients (n = 6) diagnosed with plaque-type psoriasis. Six healthy subjects received placebo. Patients with plaque psoriasis were evaluated by a dermatologist, and Physician Global Assessment (PGA) score was required to be &gt;= 3 (moderate psoriasis) at screening.ResultsA total of 31 adverse events (AEs) occurred in 13 participants during the study: 9 AEs in healthy subjects receiving GN-037 cream, 3 AEs in healthy subjects receiving placebo, and 1 AE in one psoriatic patient. The most frequently reported AEs were reactions at the application site, including erythema, exfoliation, pruritus, and burning sensation. During the baseline evaluation, one patient had a PGA score of 3 (moderate) and five patients had a PGA score of 4 (severe). On day 14, in treatment, four patients experienced second grade and two patients third grade improvements compared with baseline, indicating a shift of patients from moderate and severe disease to mild disease and to almost clear (score 2 or 1). There were slight increases in plasma tumor necrosis factor (TNF)-alpha, interleukin-17 (IL-17) and interleukin-23 (IL-23) levels in both healthy volunteers and patients throughout the study, as compared with baseline.ConclusionThe results of this phase 1 trial conducted in 18 healthy volunteers and 6 patients with plaque psoriasis demonstrated a favorable safety and tolerability profile for GN-037; therefore, further clinical development of GN-037 in a phase 2 clinical trial has been initiated in patients with mild to moderate plaque psoriasis (NCT05706870).</p>", 
  "headline": "Safety and Efficacy of a Novel Combination Cream (GN-037) in Healthy Volunteers and Patients with Plaque Psoriasis: A Phase 1 Trial", 
  "identifier": 272908, 
  "image": "https://aperta.ulakbim.gov.tr/static/img/logo/aperta_logo_with_icon.svg", 
  "license": "http://www.opendefinition.org/licenses/cc-by", 
  "name": "Safety and Efficacy of a Novel Combination Cream (GN-037) in Healthy Volunteers and Patients with Plaque Psoriasis: A Phase 1 Trial", 
  "url": "https://aperta.ulakbim.gov.tr/record/272908"
}