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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  <dc:creator>Sezer, Zafer</dc:creator>
  <dc:creator>Inal, Ahmet</dc:creator>
  <dc:creator>Cinar, Salih L.</dc:creator>
  <dc:creator>Mazicioglu, Mustafa M.</dc:creator>
  <dc:creator>Altug, Sedat</dc:creator>
  <dc:creator>Karasulu, Hatice Y.</dc:creator>
  <dc:creator>Diril, Mine</dc:creator>
  <dc:creator>Mehmetoglu, Al Ayca</dc:creator>
  <dc:creator>Kozlu, Serhat</dc:creator>
  <dc:creator>Ulu, Nadir</dc:creator>
  <dc:date>2023-01-01</dc:date>
  <dc:description>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).</dc:description>
  <dc:identifier>https://aperta.ulakbim.gov.trrecord/272908</dc:identifier>
  <dc:identifier>oai:aperta.ulakbim.gov.tr:272908</dc:identifier>
  <dc:rights>info:eu-repo/semantics/openAccess</dc:rights>
  <dc:rights>http://www.opendefinition.org/licenses/cc-by</dc:rights>
  <dc:source>DERMATOLOGY AND THERAPY 13(7) 13</dc:source>
  <dc:title>Safety and Efficacy of a Novel Combination Cream (GN-037) in Healthy Volunteers and Patients with Plaque Psoriasis: A Phase 1 Trial</dc:title>
  <dc:type>info:eu-repo/semantics/article</dc:type>
  <dc:type>publication-article</dc:type>
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