Clinical Trials Resource Center

New Medical Therapies™

Skin Wounds

Patient Medical Areas

September 8, 2014

Birken reported results of three phase III trials of Oleogel-S10 for patients with partial thickness wounds. The three phase III trials, conducted in parallel and enrolling a total of 280 patients in 48 European centers, included observer-blinded evaluation based on photographs. In the studies, patients’ wounds were divided into two halves, enabling a direct intra-individual comparison of differences between Oleogel-S10 and standard of care treatment, and avoiding confounding factors such as individual differences in wound depth and individual patient health status. In each of the three clinical phase III trials, the primary endpoint was achieved with a statistical significance of p<0.0001 (BBW-11 trial in grade 2a burn wounds and BSH-12 trial in split-thickness skin graft donor site wounds) and p=0.0232 (BSG-12 trial in split-thickness skin graft donor site wounds). The phase III results demonstrate a faster wound healing with Oleogel-S10 compared to current standard of care consisting mainly of applying wound dressing materials. Birken currently is preparing the submission of the marketing authorization application to the EMA. After approval, Oleogel-S10 will be available for marketing and distribution in the E.U. in the first half of 2016.

July 2, 2007

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.

July 19, 2004

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.

August 4, 2003

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.