Three Randomised Phase I/IIa Trials of 5% Cis-urocanic Acid Emulsion Cream in Healthy Adult Subjects and in Patients with Atopic Dermatitis




Juha M. Peltonen, Liisa Pylkkänen, Christer T. Jansén, Iina Volanen, Terhi Lehtinen, Jarmo K. Laihia, Lasse Leino

PublisherSociety for the Publication of Acta Dermato - Venereologica

2014

Acta Dermato-Venereologica

Acta Derm Venereol

94

4

415

420

6

0001-5555

DOIhttps://doi.org/10.2340/00015555-1735

http://www.medicaljournals.se/acta/content/?doi=10.2340/00015555-1735



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.

Last updated on 2024-26-11 at 11:06