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
<?xml version='1.0' encoding='UTF-8'?> <record xmlns="http://www.loc.gov/MARC21/slim"> <leader>00000nam##2200000uu#4500</leader> <datafield tag="700" ind1=" " ind2=" "> <subfield code="a">Inal, Ahmet</subfield> </datafield> <datafield tag="700" ind1=" " ind2=" "> <subfield code="a">Cinar, Salih L.</subfield> <subfield code="u">Erciyes Univ, Fac Med, Dept Dermatol, Kayseri, Turkiye</subfield> </datafield> <datafield tag="700" ind1=" " ind2=" "> <subfield code="a">Mazicioglu, Mustafa M.</subfield> <subfield code="u">Erciyes Univ, Fac Med, Dept Family Med, Kayseri, Turkiye</subfield> </datafield> <datafield tag="700" ind1=" " ind2=" "> <subfield code="a">Altug, Sedat</subfield> <subfield code="u">Demiroglu Bilim Univ, Fac Med, Dept Pharmacol, Istanbul, Turkiye</subfield> </datafield> <datafield tag="700" ind1=" " ind2=" "> <subfield code="a">Karasulu, Hatice Y.</subfield> </datafield> <datafield tag="700" ind1=" " ind2=" "> <subfield code="a">Diril, Mine</subfield> <subfield code="u">Sedef Ilac & Med Urunleri Ind Trade Co Ltd, Dept Res & Dev, Kastamonu, Turkiye</subfield> </datafield> <datafield tag="700" ind1=" " ind2=" "> <subfield code="a">Mehmetoglu, Al Ayca</subfield> <subfield code="u">Sedef Ilac & Med Urunleri Ind Trade Co Ltd, Dept Res & Dev, Kastamonu, Turkiye</subfield> </datafield> <datafield tag="700" ind1=" " ind2=" "> <subfield code="a">Kozlu, Serhat</subfield> <subfield code="u">Gen Ilac & Saglik Urunleri AS, Dept Res & Dev, ASO 2 & 3 Organize Sanayi Bolgesi, Alci OSB Mahall, TR-06930 Ankara, Turkiye</subfield> </datafield> <datafield tag="700" ind1=" " ind2=" "> <subfield code="a">Ulu, Nadir</subfield> <subfield code="u">Gen Ilac & Saglik Urunleri AS, Dept Res & Dev, ASO 2 & 3 Organize Sanayi Bolgesi, Alci OSB Mahall, TR-06930 Ankara, Turkiye</subfield> </datafield> <datafield tag="909" ind1="C" ind2="4"> <subfield code="p">DERMATOLOGY AND THERAPY</subfield> <subfield code="v">13</subfield> <subfield code="n">7</subfield> <subfield code="c">13</subfield> </datafield> <datafield tag="980" ind1=" " ind2=" "> <subfield code="a">user-tubitak-destekli-proje-yayinlari</subfield> </datafield> <datafield tag="540" ind1=" " ind2=" "> <subfield code="a">Creative Commons Attribution</subfield> <subfield code="u">http://www.opendefinition.org/licenses/cc-by</subfield> </datafield> <datafield tag="024" ind1=" " ind2=" "> <subfield code="a">10.1007/s13555-023-00939-7</subfield> <subfield code="2">doi</subfield> </datafield> <datafield tag="245" ind1=" " ind2=" "> <subfield code="a">Safety and Efficacy of a Novel Combination Cream (GN-037) in Healthy Volunteers and Patients with Plaque Psoriasis: A Phase 1 Trial</subfield> </datafield> <datafield tag="100" ind1=" " ind2=" "> <subfield code="a">Sezer, Zafer</subfield> </datafield> <datafield tag="909" ind1="C" ind2="O"> <subfield code="o">oai:aperta.ulakbim.gov.tr:272908</subfield> <subfield code="p">user-tubitak-destekli-proje-yayinlari</subfield> </datafield> <datafield tag="650" ind1="1" ind2="7"> <subfield code="2">opendefinition.org</subfield> <subfield code="a">cc-by</subfield> </datafield> <datafield tag="260" ind1=" " ind2=" "> <subfield code="c">2023-01-01</subfield> </datafield> <datafield tag="856" ind1="4" ind2=" "> <subfield code="u">https://aperta.ulakbim.gov.trrecord/272908/files/bib-c896ddc5-9d30-4f4a-a802-85bfd51f85c7.txt</subfield> <subfield code="z">md5:74bc9f0957f42aff5db78d7424b48f38</subfield> <subfield code="s">304</subfield> </datafield> <datafield tag="542" ind1=" " ind2=" "> <subfield code="l">open</subfield> </datafield> <controlfield tag="005">20240608041427.0</controlfield> <controlfield tag="001">272908</controlfield> <datafield tag="980" ind1=" " ind2=" "> <subfield code="a">publication</subfield> <subfield code="b">article</subfield> </datafield> <datafield tag="520" ind1=" " ind2=" "> <subfield code="a"><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></subfield> </datafield> </record>
Görüntülenme | 0 |
İndirme | 0 |
Veri hacmi | 0 Bytes |
Tekil görüntülenme | 0 |
Tekil indirme | 0 |