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Replidyne released positive results from three phase I trials of REP8839 for the treatment of bacterial skin and wound infections. A total of 400 subjects were enrolled in the trials. In the first study, subjects received repeated daily applications of REP8839 at three concentrations (1%, 2% and 4%), on intact and abraded skin. Safety, tolerability and skin irritancy were tested. Irritancy scores comparable to placebo were recorded for all REP8839 exposed test subjects. In the second study, subjects received repeated daily application of REP8839 on a larger surface area of intact and abraded skin. In addition to safety, tolerability and dermal irritancy, systemic exposure was evaluated. In all subjects, REP8839 was associated with low systemic exposure and low skin irritancy. In the third study, a 2% formulation of REP8839 was evaluated for its’ ability to cause long-term sensitization and irritancy. No sensitization reactions were recorded and low irritancy potential was observed. No serious adverse events occurred in any of the three trials. Based on the results, Replidyne plans to initiate a phase II trial of REP8839 for the treatment of impetigo in pediatrics by the end of 2007.
IsoTis OrthoBiologics announced positive results of their phase II study of Allox, a wound closure facilitator for the treatment of chronic skin ulcers and chronic wounds. The trial found that Allox was significantly more efficacious than placebo in closing chronic wounds. The double-blind, dose-escalating trial, which enrolled 110 subjects at 20 sites worldwide, randomized subjects to receive one of 6 doses of Allox or placebo for 16 weeks. 43 of 95 subjects receiving one of the doses of Allox (45%) achieved complete closure after 16 weeks, compared to 5 of 15 (33.3%) for placebo. The dosing regimen found to be optimal achieved the most significant results, with 57% achieving full wound closure. The study found the drug to be safe and well tolerated. IsoTis announced that it planned to submit an IND for phase III trials.
AEterna reported positive results from a phase III trial investigating Impavido (miltefosine), an alkyphospholipid for the treatment of cutaneous Leishmaniasis. Results showed that subjects taking Impavido had a 220% better cure rate compared with those in the placebo group. Data showed an average cure rate of 70% after treatment. Cure from the disease was assessed six months after the end of treatment; all skin lesions had to be healed at that time and no new skin lesions were allowed to appear. The treatment was well tolerated with the side effects of Impavido being limited to short episodes of vomiting or diarrhea. The randomized, double blind, placebo-controlled study enrolled 133 subjects in Colombia and Guatemala. Leishmaniasis is a tropical disease caused by the Leishmania parasite.