A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Gevokizumab in Subjects With Moderate to Severe Acne Vulgaris
Sponsored by XOMA (US) LLC, the purpose of this study is to determine whether gevokizumab is effective in the treatment of moderate to severe acne vulgaris. Subjects will be randomized to 1 of 3 treatment arms and will receive either placebo, low-dose gevokizumab, or high-dose gevokizumab in a sterile solution administered subcutaneously on day 0, day 28, and day 56.
The primary outcome measure is the mean absolute change from baseline in inflammatory facial lesion count at day 84, and the secondary outcome measure is the proportion of subjects with a successful treatment outcome at day 84. A successful treatment outcome is defined as an improvement of ≥2 grades from the baseline grade on the dichotomized facial Investigator's Global Assessment scale.
Subjects aged 18 years and older with a diagnosis of moderate to severe acne vulgaris that is unresponsive to oral antibiotics and who are willing to maintain their current habits for facial cleaning, shaving, and application of cosmetics through the end of the study are eligible for inclusion.
Exclusion criteria include: use medications or treatments from specified pretreatment time periods through the end of the study; a beard, mustache, sideburns, or other facial hair that may interfere with evaluation; other forms of acne; history of malignancy within the past 5 years; history of allergic or anaphylactic reactions to monoclonal antibodies; history of tuberculosis; and a history of chronic systemic infections. Female subjects who are pregnant or planning to become pregnant will also be excluded. Other protocol-defined inclusion/exclusion criteria may apply.
A Double-Blinded, Randomized Placebo-Controlled Pilot Study Comparing the Efficacy and Safety of IncobotulinumtoxinA Versus Saline Injections to the Cheek Region in Patients With Rosacea
Sponsored by DeNova Research, this pilot study will enroll and treat a total of 10 subjects who present with rosacea of the cheek area. Upon study entry, subjects will be randomized to receive treatment with incobotulinumtoxinA or bacteriostatic saline to the cheek area. Study treatment will be prepared by an unblinded designee and both physician investigator and subject will remain blinded for the duration of the study. At the 16-week visit, control subjects will enter the rescue arm portion of the study, and all study subjects will receive treatment with incobotulinumtoxinA to the cheek areas.
The primary outcome measures are the change in rosacea, as determined by live rosacea assessment for each side of the face using the Rosacea Clinical Scorecard for clinical assessment, and the safety of the treatment, as determined by the rate of adverse events. The secondary outcome measures are change in self-esteem, as determined by patient self-evaluation using the Heatherton & Polivy State Self-Esteem Scale; patient satisfaction, as determined by a 4-point categorical assessment; and first impression. Upon completion of all visits, active treatment subjects' baseline, 17-week, and 20-week visit photographs will be randomly assigned to 1 of 3 photography binders and evaluated by 100 blinded evaluators (300 evaluations in total).
Patients aged 18 to 65 years presenting with rosacea in the cheek area are eligible for inclusion in this study. Subject must be willing and able to comply with protocol requirements, including returning for follow-up visits and abstaining from exclusionary procedures for the duration of the study. Subjects must also be willing and able to provide written photo consent and adherence to photography procedures and to provide written informed consent before performance of any study-related procedure.
Subjects cannot participate if they are pregnant, nursing, planning to become pregnant, and/or not using a reliable form of birth control; have a known allergy or sensitivity to any component of the study medications or anesthesia; have a significant systemic illness or illness localized to the areas of treatment; have been diagnosed with of myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis, or any other disease that might interfere with neuromuscular function or current facial palsy; or are currently using aminoglycoside antibiotics, curare-like agents or other agents that might interfere with neuromuscular function. Additional exclusion criteria include: use of topical or oral rosacea treatments within the past 2 weeks; botulinum toxin to the face within the past 6 months; significant concurrent illness such as diabetes, epilepsy, lupus, or congestive heart failure; concurrent skin condition affecting area to be treated; prior surgery on the area to be treated within 3 months of initial treatment or during the study; history or evidence of keloids or hypertrophic scarring; history of chronic drug or alcohol abuse; concurrent therapy that, in the investigator's opinion, would interfere with the evaluation of the safety or efficacy of the study medication; and enrollment in any active study involving the use of investigational devices or drugs.