The safety and efficacy of Luxíq has been demonstrated in a four-week trial. An adequate and well-controlled clinical trial was conducted in 190 patients with moderate to severe scalp psoriasis. Patients were treated twice daily for four weeks with Luxíq Foam, Placebo foam, a commercially available betame-thasone valerate lotion % (formerly expressed as % betamethasone), or Placebo lotion. At four weeks of treatment, study results of 159 patients demonstrated that the efficacy of Luxíq Foam in treating scalp psoriasis is superior to that of Placebo foam, and is comparable to that of a currently marketed BMV lotion (see Table below).
The rationale for the use of vitamin D derivatives in the treatment of psoriasis is based on the observation that patients with hypocalcemia often develop various forms of psoriasis, most notably the pustular form. In one case, a patient who had undergone thyroidectomy developed repeated flares of pustular psoriasis after decreases were made in her dosage of ergocalciferol (Vitamin D 2 ); each episode was related to severe hypocalcemia and resolved after her serum calcium levels normalized. 14 Another patient with osteoporosis experienced dramatic improvement in severe psoriasis after receiving an oral form of vitamin D. 15 This finding, along with the discovery that the bioactive form of 1,25-dihydroxycholecalciferol has been shown to inhibit keratinocyte proliferation and promote keratinocyte differentiation, 16 has led to the development of vitamin D analogs for the treatment of psoriasis.