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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  <identifier identifierType="URL">https://aperta.ulakbim.gov.tr/record/272908</identifier>
  <creators>
    <creator>
      <creatorName>Sezer, Zafer</creatorName>
      <givenName>Zafer</givenName>
      <familyName>Sezer</familyName>
    </creator>
    <creator>
      <creatorName>Inal, Ahmet</creatorName>
      <givenName>Ahmet</givenName>
      <familyName>Inal</familyName>
    </creator>
    <creator>
      <creatorName>Cinar, Salih L.</creatorName>
      <givenName>Salih L.</givenName>
      <familyName>Cinar</familyName>
      <affiliation>Erciyes Univ, Fac Med, Dept Dermatol, Kayseri, Turkiye</affiliation>
    </creator>
    <creator>
      <creatorName>Mazicioglu, Mustafa M.</creatorName>
      <givenName>Mustafa M.</givenName>
      <familyName>Mazicioglu</familyName>
      <affiliation>Erciyes Univ, Fac Med, Dept Family Med, Kayseri, Turkiye</affiliation>
    </creator>
    <creator>
      <creatorName>Altug, Sedat</creatorName>
      <givenName>Sedat</givenName>
      <familyName>Altug</familyName>
      <affiliation>Demiroglu Bilim Univ, Fac Med, Dept Pharmacol, Istanbul, Turkiye</affiliation>
    </creator>
    <creator>
      <creatorName>Karasulu, Hatice Y.</creatorName>
      <givenName>Hatice Y.</givenName>
      <familyName>Karasulu</familyName>
    </creator>
    <creator>
      <creatorName>Diril, Mine</creatorName>
      <givenName>Mine</givenName>
      <familyName>Diril</familyName>
      <affiliation>Sedef Ilac &amp; Med Urunleri Ind Trade Co Ltd, Dept Res &amp; Dev, Kastamonu, Turkiye</affiliation>
    </creator>
    <creator>
      <creatorName>Mehmetoglu, Al Ayca</creatorName>
      <givenName>Al Ayca</givenName>
      <familyName>Mehmetoglu</familyName>
      <affiliation>Sedef Ilac &amp; Med Urunleri Ind Trade Co Ltd, Dept Res &amp; Dev, Kastamonu, Turkiye</affiliation>
    </creator>
    <creator>
      <creatorName>Kozlu, Serhat</creatorName>
      <givenName>Serhat</givenName>
      <familyName>Kozlu</familyName>
      <affiliation>Gen Ilac &amp; Saglik Urunleri AS, Dept Res &amp; Dev, ASO 2 &amp; 3 Organize Sanayi Bolgesi, Alci OSB Mahall, TR-06930 Ankara, Turkiye</affiliation>
    </creator>
    <creator>
      <creatorName>Ulu, Nadir</creatorName>
      <givenName>Nadir</givenName>
      <familyName>Ulu</familyName>
      <affiliation>Gen Ilac &amp; Saglik Urunleri AS, Dept Res &amp; Dev, ASO 2 &amp; 3 Organize Sanayi Bolgesi, Alci OSB Mahall, TR-06930 Ankara, Turkiye</affiliation>
    </creator>
  </creators>
  <titles>
    <title>Safety And Efficacy Of A Novel Combination Cream (Gn-037) In Healthy Volunteers And Patients With Plaque Psoriasis: A Phase 1 Trial</title>
  </titles>
  <publisher>Aperta</publisher>
  <publicationYear>2023</publicationYear>
  <dates>
    <date dateType="Issued">2023-01-01</date>
  </dates>
  <resourceType resourceTypeGeneral="Text">Journal article</resourceType>
  <alternateIdentifiers>
    <alternateIdentifier alternateIdentifierType="url">https://aperta.ulakbim.gov.tr/record/272908</alternateIdentifier>
  </alternateIdentifiers>
  <relatedIdentifiers>
    <relatedIdentifier relatedIdentifierType="DOI" relationType="IsIdenticalTo">10.1007/s13555-023-00939-7</relatedIdentifier>
  </relatedIdentifiers>
  <rightsList>
    <rights rightsURI="http://www.opendefinition.org/licenses/cc-by">Creative Commons Attribution</rights>
    <rights rightsURI="info:eu-repo/semantics/openAccess">Open Access</rights>
  </rightsList>
  <descriptions>
    <description descriptionType="Abstract">&lt;p&gt;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 &amp;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).&lt;/p&gt;</description>
  </descriptions>
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