ACNE VULGARIS
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.
ROSACEA
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.
