title: Three randomised phase I/IIa trials of 5% cis-urocanic acid emulsion cream in healthy adult subjects and in patients with atopic dermatitis.
abstract: New treatment modalities are needed in atopic dermatitis. We evaluated the pharmacokinetics, safety, tolerability, and efficacy of topical cis-urocanic acid (cis-UCA) cream in randomised vehicle-controlled double-blinded clinical trials. The subjects received 5% cis-UCA emulsion cream and control vehicle on volar forearms after right-left randomisation. Study 1: 16 healthy subjects received one dose on the skin and, a week later, on DMSO-irritated skin. Study 2: 16 healthy subjects received 2 daily doses for 10 days. Study 3: 13 patients with mild to moderate disease were treated on selected skin lesions twice daily for 28 days. Study treatments were well tolerated. cis-UCA remained close to endogenous levels in plasma and urine. cis-UCA reduced transepidermal water loss (TEWL) both in healthy subjects and in the patients. Eczema area severity index and physician's global assessment improved from baseline with both treatments. cis-UCA cream improved skin barrier function and suppressed inflammation in the human skin.
authors.affiliation: Clinical Research Services, FIN-20520 Turku, Finland.
authors.forename: Juha M
authors.initials: JM
authors.lastname: Peltonen
authors.forename: Liisa
authors.initials: L
authors.lastname: Pylkkänen
authors.forename: Christer T
authors.initials: CT
authors.lastname: Jansén
authors.forename: Iina
authors.initials: I
authors.lastname: Volanen
authors.forename: Terhi
authors.initials: T
authors.lastname: Lehtinen
authors.forename: Jarmo K
authors.initials: JK
authors.lastname: Laihia
authors.forename: Lasse
authors.initials: L
authors.lastname: Leino
mesh_terms: D000279:Administration, Cutaneous; D003876:Dermatitis, Atopic / Q000175:diagnosis / Q000188:drug therapy* / Q000276:immunology; D003879:Dermatologic Agents / Q000008:administration & dosage* / Q000009:adverse effects / Q000493:pharmacokinetics; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D004655:Emulsions; D005387:Finland; D006801:Humans; D011446:Prospective Studies; D012720:Severity of Illness Index; D012867:Skin / Q000187:drug effects* / Q000276:immunology / Q000473:pathology; D013997:Time Factors; D016896:Treatment Outcome; D014560:Urocanic Acid / Q000008:administration & dosage* / Q000009:adverse effects / Q000493:pharmacokinetics
chemical_list: D003879:Dermatologic Agents; D004655:Emulsions; D014560:Urocanic Acid