LiLi trial: Liarozole in lamellar
ichthyosis
Brief description. The LiLi
trial is a randomised, double-blind, multinational,
multicentre, placebo-controlled parallel phase II/III trial to
evaluate the efficacy and safety of 2 treatment regimens of
oral liarozole (75 m0g o.d. and 150 mg o.d.) given during 12
weeks in comparison with placebo in the treatment of subjects
with lamellar ichthyosis. The primary objective of the study
is to demonstrate the efficacy of oral liarozole vs placebo in the treatment of lamellar ichthyosis, measured by
the average Overall Scaling Score and evaluated by the
investigator at the end of 12 weeks of treatment. Secondary
objectives includes comparison between liarozole and placebo
on (i) severity scores of erythema and pruritus, (ii) quality
of life, (iii) photographs, (iv) safety and tolerability, (v)
use of emollients and mechanical scale removal.
Coordinating investigator. Prof. Milstone
for United States. Prof. Traupe (Geneskin participant 5) for
Europe. traupeh@mednet.uni-muenster.de
Participant centres. CANADA: Dr.
Gulliver, Dr. Marcoux. DOMINICAN REPUBLIC: Dr. Blanco. FRANCE:
Dr. Blanchet-Bardon, Prof. Bodemer (Geneskin participant 17),
Prof. Stalder, Prof. Tajeb (Geneskin participant 14C).
GERMANY: Prof. Gollnick, Dr. Korge, Prof. Küster, Prfo. Traupe
(Geneskin participant 5). ITALY: Dr. Didona (Geneskin
participant 1A), Prof. Caputo. BELGIUM: Dr. Boonen, Dr.
Rosseeuw. NETHERLANDS: Prof. Oranje, Prof. Steijlen. NORWAY:
Dr. Mønk. SWEDEN: Prof. Vahlquist (Geneskin participant 27).
Orphagen
Brief description. Orphagen is
international multicenter phase II trial aimed to
investigate the efficacy and tolerance of tazarotene cream in
patients with lamellar ichthyosis. This is a randomized, double blind,
vehicle-controlled, with right/left comparison study and will start by
the end of 2008.
Participant centers. Ten
participating centers are expected, including Prof. Heiko
Traupe (participant 5), Prof. Alain Hovnanian (participant
14B), and Prof. Christine Bodemer (participant 17).
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