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news.Revance Therapeutics has released the results of two Phase 2b clinical trials on RT001, a topical botulinum toxin type A, which is under investigation for the treatment of lateral canthal lines (crow's feet wrinkles).
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The two multi-center, double-blind, randomised, controlled studies showed that RT001 was well tolerated and demonstrated efficacy versus controls.
Revance said that the first study enrolled 90 subjects and utilised a primary composite endpoint that included ratings by both the investigator and the patient on validated wrinkle severity scales.
Reportedly, in the study, RT001 met the primary endpoint and all secondary endpoints.
Principal investigator of the study Fredric Brandt said that a treatment that shows such promising results should appeal to a wide variety of new patients, many of whom do not like having a needle so close to their eyes and have been hesitant to come in for a cosmetic procedure.
Revance stated that the second study had 180 subjects and was designed to compare the individual components comprising RT001 which include botulinum toxin type A, the proprietary peptide carrier and the vehicle.
Reportedly, in the study, RT001 met the primary endpoint of greater that equal to 2-point improvement in lateral canthal line severity on both sides of the face as measured by the investigator.
The results were significant compared to each component of RT001 individually and all the components combined.
Maryland Laser, Skin & Vein Institute director and Johns Hopkins Dermatology associate professor Robert Weiss said that the data confirm that large proteins such as botulinum toxin type A don’t have the ability to cross skin by themselves.
Revance president and CEO Dan Browne said that they were pleased by the results generated in the RT001 clinical program.