CLINICAL TRIAL REVIEW
October 2011 | Volume 10 | Issue 10 | Feature | 1216 | 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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Treatment of Surgical Scars Using the Pulsed Dye Laser
Sponsored by the University of California, San Diego. The purpose of this study is to determine whether treatment of fresh surgical scars with a 595 nm pulsed dye laser using purpurainducing settings will improve clinical appearance better than one using non-purpura-inducing settings or no treatment.
The primary outcome measure will be the Vancouver Scar Scale score. The secondary outcome measures will be subjective rating of pain on a scale of 0 to 10 and cosmetic appearance of the scar.
Inclusion criteria: Patients requiring Mohs micrographic surgery or excisions for skin cancer or atypical nevi, with an expected post-excision scar of 4.5 cm in length or more; willing to participate; able to give informed consent.
Exclusion criteria: Location of excision or Mohs surgery on the genitals, hands, or feet; Fitzpatrick skin type V or VI; prior history of known light sensitivity.
Safety and Efficacy of Secukinumab Compared to Etanercept in Subjects With Moderate-to-Severe Chronic Plaque-Type Psoriasis
Sponsored by Novartis Pharmaceuticals. The purpose of this study is to assess the safety and efficacy of secukinumab compared to placebo and etanercept in patients that have moderateto- severe chronic plaque-type psoriasis.
The primary outcome measure will be efficacy of secukinumab compared to placebo in subjects using PASI (Psoriasis Area and Severity Index) and IGA (Investigator's Global Assessment). The secondary outcome measures will be efficacy of secukinumab compared to etanercept in subjects using PASI and IGA, clinical safety and tolerability of secukinumab in subjects compared to etanercept and placebo, and quality of life changes measured using patient-reported outcome questionnaires.
Inclusion criteria: Subjects with chronic, plaque-type psoriasis for at least six months; must have moderate-to-severe psoriasis based on PASI greater than 12, IGA greater than 3 and greater than 10 percent body surface area; must be inadequately controlled by prior treatments (topicals, phototherapy and/or systemic therapies).
Exclusion criteria: Forms of psoriasis other than chronic plaquetype (such as pustular, erythrodermic and guttate psoriasis); drug-induced psoriasis; use of other psoriasis treatments during the study; prior use of etanercept; prior use of secukinumab or any other drugs that target IL-17 (interleukin 17) or the IL-17 receptor; pregnant or lactating women; women who do not agree to use contraception during the study and for 16 weeks after stopping treatment; significant medical problems such as uncontrolled high blood pressure, congestive heart failure, etc.; history of an ongoing, chronic or recurrent infection or evidence of tuberculosis; allergy to rubber or latex.
ACNE AND ROSACEA
Phase 3 Efficacy and Safety Study of CD07805/47 Topical Gel in Subjects With Facial Erythema Associated With Rosacea
Sponsored by Galderma. The purpose of this study is to test the hypothesis that CD07805/47 gel, applied topically once