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Replies to post #192028 on Biotech Values
06/14/15 3:06 PM
07/02/15 4:10 PM
09/09/15 8:01 PM
Revance's Phase 2, randomized, double-blind, dose-ranging, placebo-controlled trial will evaluate the safety and efficacy of RT001 topical gel for the treatment of primary axillary hyperhidrosis. A total of approximately 60 adult patients with a diagnosis of primary axillary hyperhidrosis will be enrolled at multiple sites in the U.S. The patients will be randomized into one of three parallel treatment groups (two doses of RT001 topical gel and one placebo topical gel). The product will be applied to both underarms.
An interim efficacy and safety analysis at Day 28 after treatment is planned. The primary efficacy endpoints are the proportion of subjects who are 2-point or greater responders from baseline using the Hyperhidrosis Disease Severity Scale (HDSS) and the absolute change from baseline in the gravimetrically measured sweat production. Secondary efficacy endpoints include the change from baseline in total Dermatology Life Quality Index (DLQI) scores.
…The company plans to release interim data from this study by year end 2015
09/28/15 8:55 PM
Revance Therapeutics, Inc…today announced it has commenced dosing patients in the Phase 3 pivotal study to evaluate the safety and efficacy of its RT001 investigational topical drug product candidate for the treatment of lateral canthal lines, or crow's feet… The company plans to release interim results from this Phase 3 study in the first half of 2016.
…The Phase 3 trial is a randomized, double-blind, parallel-group, placebo-controlled study to evaluate the safety and efficacy of RT001, also referred to as RTT150 (Botulinum Toxin Type A) Topical Gel, for the treatment of moderate to severe lateral canthal lines. A total of up to 450 adult patients will be enrolled at multiple sites in the United States and will be randomized 1:1 to a single treatment of either RT001 topical gel or placebo. The product will be applied to lateral canthal lines on both sides of the face using Revance's proprietary applicator.
The primary efficacy endpoints are composites based upon the Investigator's Global Assessment of Lateral Canthal Lines (IGA-LCL) assessment and the Patient Severity Assessment (PSA) between baseline and 28 days after treatment.
One composite endpoint includes those patients with a 2-point or greater improvement as graded by the investigator's assessment and the patient's self-assessment. The other composite endpoint includes those patients who experience a 1-point or greater improvement in the investigator's and patient's assessments.
12/23/15 7:13 PM
The trial was designed to evaluate safety and efficacy of two doses of RT001 applied on a single day of treatment. Although the trial sample size was not chosen to meet statistical significance, using quantitative gravimetric measurements, the data was positive and showed that a single treatment of RT001 topical gel achieved clinically meaningful efficacy at Week 4. Using the qualitative Hyperhidrosis Disease Severity Scale (HDSS), RT001 showed a strong efficacy trend for both 1-point and 2-point improvement.
…On the primary qualitative efficacy assessment of a 2-point or greater responders from baseline using the HDSS, at Weeks 1 and 2 the results ranged from a 23.8% to 13.3 % improvement for RT001 compared to a range of 17.6% to 11.8% improvement for placebo. By Week 4, there was a 14.3% to 13.3% improvement for RT001, compared to a 29.4% improvement in patients who received placebo [i.e. the placebo arm did better].
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