Original Research 9-cis–Rich b-Carotene Powder of the Alga Dunaliella Reduces the Severity of Chronic Plaque Psoriasis: A Randomized, Double-Blind, Placebo-Controlled Clinical Trial Shoshana Greenberger, MD, PhD, Dror Harats, MD, Fares Salameh, MD, Tamar Lubish, RN, Ayelet Harari, PhD, Henri Trau, MD, Aviv Shaish, PhD Department of Dermatology (S.G., F.S., H.T.) and The Bert W. Strassburger Lipid Center (S.G., D.H., T.L., A.H., A.S.), Chaim Sheba Medical Center, Tel Hashomer, ISRAEL Key words: psoriasis, 9-cis b-carotene, Dunaliella, double-blind, placebo-controlled clinical trial Background: Synthetic retinoids are one of the mainstay treatments of psoriasis. However, their use is occasionally limited by adverse effects, especially mucocutaneous, hepatic, and lipid profile toxicity. Thus, a search for retinoid metabolites that are both safe and active is essential. The alga Dunaliella bardawil is a natural source of the retinoid precursor 9-cis b-carotene that has a good adverse effect profile. Objective: To test the effect of the alga Dunaliella bardawil on psoriasis. Methods: Thirty-four adult patients with mild, chronic, plaque-type psoriasis were included in this monocentric, prospective, randomized, double-blinded pilot study. Patients received either capsules of the alga D. bardawil or starch powder capsules, as the placebo, for 12 weeks. The response to treatment was evaluated by changes in Psoriasis Area and Severity Index (PASI) and Dermatology Life Quality Index (DLQI) scores. Safety of the treatment was evaluated. Results: At the end of 6 weeks, the reduction in the mean PASI score was significantly higher in the Dunaliella group than in the placebo group (61.3% vs 34%, respectively, p ¼ 0.002). The DLQI change did not reach significance (8.5% and 5.9% in the Dunaliella and in the control group, respectively, p ¼ 0.9). We observed no significant change in the liver function tests or in the lipid profile. Conclusions: 9-cis b-carotene, in the form of D. bardawil, is an effective and safe treatment for patients with mild, chronic, plaque-type psoriasis. A larger study is warranted. INTRODUCTION Psoriasis is a chronic skin disease affecting approximately 2% to 3% of the world population [1,2], which could have a devastating influence on the affected individual’s life quality [3–5]. Presently, psoriasis is without a permanent cure, and treatment is aimed mainly at reducing the clinical symptoms. Although new biological-immunological therapies are being developed, oral retinoids remain one of the mainstay treatments [6]. Since the 1930s, vitamin A deficiency has been known to cause hyperkeratosis of the skin ( phrynoderma), and as early as the 1960s, synthetic vitamin A (composed mainly of all-trans- retinol) has been used for the treatment of psoriasis [7–9], although with low efficacy over the toxicity ratio. Further research resulted in the development of the second generation of retinoids, etretinate and its pharmacologically active metabolite acitretin [10]; both represent highly effective systemic treatments for psoriasis [11]. However, despite the demonstrated clinical success of retinoid therapy, this treatment has a significant potential for toxicity, especially elevated liver functions, elevated plasma triglycerides, and low-density lipoprotein (LDL) cholesterol; therefore, it requires close Address correspondence to Shoshana Greenberger, The Bert W. Strassburger Lipid Center and the Department of Dermatology, Sheba Medical Center, Tel Hashomer, 52621 ISRAEL. E-mail: shoshana.greenberger@sheba.health.gov.il Conflict of interest declaration: This work was supported by Nikken Sohonsha Corporation, Japan. //Xinet/production/j/jacn/live_jobs/jacn-31-05/jacn-31-05-07/layouts/jacn-31-05-07.3d  Tuesday, 16 October 2012  3:33 am  Allen Press, Inc.  Page 1 Journal of the American College of Nutrition, Vol. 31, No. 5, 000–000 (2012) Published by the American College of Nutrition 0