Clinical Trial Review
June 2011 | Volume 10 | Issue 6 | Original Article | 687 | Copyright © 2011
Clinical Trial Review is a JDD department designed to provide physicians with information on drugs and devices undergoing clinical testing. It is our goal to inform the reader of the status of select drug and device studies relevant to the practice of dermatology before this information is available through standard channels. To participate in or learn more about these and additional trials, visit www.clinicaltrials.gov.
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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.
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.