CLINICAL TRIAL REVIEW
April 2011 | Volume 10 | Issue 4 | Original Article | 426 | Copyright © April 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.
A Dose-Ranging Study Evaluating the Safety and
Efficacy of IDP-107 in Patients With Acne Vulgaris
Sponsored by Dow Pharmaceutical Sciences. The purpose of
this study is to evaluate the safety and efficacy of IDP-107 versus
placebo in treating patients with acne vulgaris.
The primary outcome measure will be to measure the change
from baseline in the number of inflammatory lesions and to
determine the percent of patients who achieve success for the
acne global severity score. The secondary outcome measure
will be to measure the change from baseline in the number of
Treatment of Actinic Keratoses of the Face
With Imiquimod 3.75% Cream Followed by
Sponsored by the Tennessee Clinical Research Center. Collaborator:
Graceway Pharmaceuticals, LLC. The purpose of this
study is to explore the effect of treating actinic keratoses of the
face with imiquimod 3.75% cream followed by photodynamic
therapy in comparison to treatment with imiquimod alone.
The primary outcome measures will be to evaluate the actinic
keratosis count and the percent change in actinic keratosis count
as compared to the baseline lesion count. The secondary outcome
measures will be to assess complete clearance and the
proportion of patients with complete clearance of actinic keratoses
in the treatment area (entire face); to assess cosmetic appearance;
and to evaluate change in investigator and patient scores
of cosmetic appearance of the treatment area (entire face).
Imiquimod 3.75% Cream in Combination With
Cryotherapy in the Treatment of Hypertrophic
Sponsored by Amylynne Frankel, MD. Collaborator: Graceway
Pharmaceuticals, LLC. This study aims to examine the benefit of
cryotherapy in combination with imiquimod 3.75% compared
to cryotherapy alone.
The primary outcome measures will be to assess the clearance
of Actinic Keratoses, AK lesion count, and photography.
The secondary outcome measure will be to evaluate Local Skin