CLINICAL TRIAL REVIEW
April 2011 | Volume 10 | Issue 4 | Original Article | 426 | 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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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 non-inflammatory lesions.
Treatment of Actinic Keratoses of the Face With Imiquimod 3.75% Cream Followed by Photodynamic Therapy
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 Actinic Keratoses
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 Reactions (LSRs).