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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    "communities": [
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        "id": "tubitak-destekli-proje-yayinlari"
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    "creators": [
      {
        "name": "Sezer, Zafer"
      }, 
      {
        "name": "Inal, Ahmet"
      }, 
      {
        "affiliation": "Erciyes Univ, Fac Med, Dept Dermatol, Kayseri, Turkiye", 
        "name": "Cinar, Salih L."
      }, 
      {
        "affiliation": "Erciyes Univ, Fac Med, Dept Family Med, Kayseri, Turkiye", 
        "name": "Mazicioglu, Mustafa M."
      }, 
      {
        "affiliation": "Demiroglu Bilim Univ, Fac Med, Dept Pharmacol, Istanbul, Turkiye", 
        "name": "Altug, Sedat"
      }, 
      {
        "name": "Karasulu, Hatice Y."
      }, 
      {
        "affiliation": "Sedef Ilac & Med Urunleri Ind Trade Co Ltd, Dept Res & Dev, Kastamonu, Turkiye", 
        "name": "Diril, Mine"
      }, 
      {
        "affiliation": "Sedef Ilac & Med Urunleri Ind Trade Co Ltd, Dept Res & Dev, Kastamonu, Turkiye", 
        "name": "Mehmetoglu, Al Ayca"
      }, 
      {
        "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"
      }, 
      {
        "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"
      }
    ], 
    "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>", 
    "doi": "10.1007/s13555-023-00939-7", 
    "has_grant": false, 
    "journal": {
      "issue": "7", 
      "pages": "13", 
      "title": "DERMATOLOGY AND THERAPY", 
      "volume": "13"
    }, 
    "license": {
      "id": "cc-by"
    }, 
    "publication_date": "2023-01-01", 
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    "resource_type": {
      "subtype": "article", 
      "title": "Dergi makalesi", 
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    "science_branches": [
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    "title": "Safety and Efficacy of a Novel Combination Cream (GN-037) in Healthy Volunteers and Patients with Plaque Psoriasis: A Phase 1 Trial"
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