Results of the study of 17 subjects with moderate to severe acne indicated that 16 of 17 subjects (94%) experienced a reduction in total acne lesion count of more than 50%, and 6 of the 17 subjects (35%) were considered “cleared or almost cleared.”
To be considered “cleared or almost cleared” a subject must have had more than 90% reduction in total lesion count.
According to the company, inflammatory and non-inflammatory lesions responded equally well to treatment. There were no serious treatment-related adverse effects reported. Non-serious side effects experienced by this patient group included some dryness of skin and lips.
Barrier also conducted a study with its topical formulation of Rambazole in which each of 15 healthy volunteers were treated for 9 days with both the drug at a 0.07% concentration or a 0.35% concentration and its vehicle. Skin biopsies were taken and analyzed for three key biological markers that are known signals for potential therapeutic effect when topical retinoids are applied.
The results from the analysis of the Rambazole treated skin compared to vehicle treated skin showed strong dose dependent activity with changes of 10 to 1000 fold for these biological markers as compared to baseline, whereas virtually no changes were seen in the vehicle treated skin.
“These positive phase 2a results indicate that … this drug may one day fill the need for safe and effective oral treatments for moderate and severe acne. These results further build on our previously announced promising clinical data for oral Rambazole for psoriasis,” stated Dr Geert Cauwenbergh, chairman and CEO of Barrier Therapeutics.