Changes to clinical protocols between Phase II and Phase III always leave companies open to disappointment, as untested variables are introduced into pivotal studies. The latest victim is Cellegy Pharmaceuticals Inc., whose Phase III trial of Glylorin monolaurin for congenital ichthyosiform erythroderma failed to show a difference from placebo cream in the primary end point of scaling.

The skin condition is characterized by scaling. CLGY (Foster City, Calif.) appears to have run into three problems: a change in protocol that led to problems with patient compliance; unequal randomization; and a small patient population that probably exacerbated the first two issues.