ACNE
Study of a New Drug Treatment for Acne
Sponsored by Johnson & Johson. The purpose of this multicenter,
double-blind, vehicle controlled, phase 2 study is to determine
if three different doses of a new acne treatment are
safe and better at reducing facial acne than a treatment without
active ingredient.
The primary outcome measure will be to calculate the change
in total acne lesion counts between baseline and end of study.
The secondary outcome measures will be to calculate the
change in sum of open and closed comedones, calculate the
change in sum of papules and pustules, measure the change in
sum of inflammatory and non-inflammatory lesions throughout
the study, evaluate the percent change in sum of open and
closed comedones, evaluate the percent change in sum of papules
and pustules, measure the percent change in inflammatory
lesions and non-inflammatory lesions, evaluate the change
from baseline in weekly Investigator's Global Assessment (IGA)
scores (proportion of success according to Improvement of
two grades from the baseline score), measure the change from
baseline in weekly IGA scores (proportion of success according
to Clear or almost clear (Grades 0 or 1)), and evaluate change
from baseline in weekly IGA scores (proportion of success according
to dichotomized IGA using a combination of the following
criteria: a) Improvement of two grades from the baseline
score, b) Clear or almost clear (Grades 0 or 1)).
Inclusion criteria: Individuals 12 years of age or older, with
moderate facial acne vulgaris as defined in the protocol; if female
of childbearing potential, must take a pregnancy test and
have a negative result; females of childbearing potential must
also agree to use an adequate method of birth control.
Exclusion criteria: Known sensitivity to any of the ingredients
in the study medication; more than three nodulocystic acne lesions;
use of acne treatments, therapies or medications within
protocol-specified timeframes; presence of other skin conditions,
diseases, or medical conditions that (per protocol or in
the opinion of the investigator) may require concurrent therapy,
interfere with the evaluation of the study medication, or
compromise subject safety; excessive facial hair that may interfere
with application of the medication and/or evaluations.
ATOPIC DERMATITIS
Safety Study of AMG 157 in Healthy Subjects and Subjects With Atopic Dermatitis
Sponsored by Amgen. This study is a phase I single dose escalation
study of AMG 157 in healthy subjects and subjects with
moderate-to-severe atopic dermatitis. The purpose of the study
is to evaluate the safety, tolerability and pharmacokinetics of
AMG 157.
The primary outcome measures will be to calculate subject incidence
of treatment-emergent adverse events, measure clinically
significant changes in vital signs, physical examinations, laboratory
safety tests, ECGs and the development of anti-AMG 157
antibodies.
The secondary outcome measures will be to calculate serum
PK parameters and to assess the Eczema Area & Severity Index
(EASI) score and Investigator's Global Assessment (IGA) score.
Inclusion criteria: Subject must sign an Institutional Review
Board (IRB) approved informed consent form before any study
specific procedures; subjects must be aged between 18 and 45
years, inclusive (Part A only); female subjects must be of non-reproductive
potential; male subjects with partners of childbearing
potential should inform their partner of their participation in this
clinical study and use highly effective methods of birth control
during the study; healthy subjects must have a body mass index
(BMI) between 18 to 32 kg/m2, inclusive; subject must have normal
or clinically acceptable physical examination, clinical laboratory
tests and electrocardiogram (ECG) results; for Part B, subject
must have active AD affecting ≥10 percent body surface area,
EASI score ≥15, aged between 18 and 60 years, inclusive and
BMI between 18 and 35 kg/m2, inclusive.
