Clinical Trial Report openaccess articles

April 2015 | Volume 14 | Issue 4 | Feature | 424 | Copyright © 2015

Abstract

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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PLAQUE PSORIASIS

A Long Term Study to Evaluate the Safety and Tolerability of CP-690,550 for Patients With Moderate to Severe Chronic Plaque Psoriasis

Sponsored by Pfizer, the main objective of this study is to evaluate the long-term safety of CP-690,550 in patients being treated for moderate to severe chronic plaque psoriasis. This is an open label extension study available to patients who participated in one of the qualifying studies with CP-690,550, providing entry criteria are met.

The study is anticipated to continue for up to at least 2 years post First Market Approval (FMA) in a global, major market. All subjects will receive 10 mg BID of CP-690,550 for the first 3 months of the trial. The study has the option for variable dosing with 5 mg or 10 mg BID after first 3 months of treatment based on PI discretion.

Primary outcome measures include incidence and severity of adverse events, incidence of clinical laboratory abnormalities, change from baseline (in this and/or prior study) in clinical laboratory values, and changes in physical examination from baseline during treatment (Time frame: month 1, month 3, and every 3 months thereafter until approximately April 2017).

table 1

FACIAL LIPOATROPHY

Voluma Filler Agent for the Treatment of HIV-Associated Facial Lipoatrophy

Sponsored by the VA Northern California Health Care System in collaboration with Allergan, the purpose of this study is to test the safety of Voluma and see what effects it has on HIV facial lipoatrophy. The hypothesis is that Voluma will be safe and efficacious, and positively impact the quality-of-life in the treatment of facial lipoatrophy in patients with HIV.

HIV facial lipoatrophy (volume loss) is an increasing concern with patients on Highly Active Anti-Retroviral Therapy (HAART) because it affects the quality-of-life and adherence to medication regimen. Treatment of HIV facial lipoatrophy helps to improve patient wellness by removing the social stigma associated with HIV facial lipoatrophy. Currently, there are few medical therapies that can treat HIV facial lipoatrophy and are FDA-approved for this indication.

Voluma is the only agent that is FDA-approved for facial volume loss. The investigators anticipate Voluma having fewer adverse effects than current FDA-approved drugs for HIV lipoatrophy as Voluma is a hyaluronic acid (HA)-based agent. The benefit of using hyaluronidase to "correct" or "modify" facial HA-based volume therapy is also a benefit for HIV patients, which currently does not exist as a post-injection modification option for other FDA-approved filling agents used to treat patients with HIV facial lipoatrophy.

table 2

BURN INJURIES

A Comparison of Medihoney® Gel With Active Leptospermum Honey and Santyl® in the Treatment of Partial Thickness Burns

Sponsored by Allegheny Singer Research Institute, the objective of this study is to assess the efficacy of Medihoney® Gel with Active Leptospermum honey dressing relative to Santyl® ointment dressing on the time to heal, bacterial growth in the wound, patient satisfaction, and treatment costs in patients with partial thickness burns.

It is hypothesized that, compared with Santyl®, Medihoney® gel with active leptospermum honey will result in significantly faster wound healing, its sites will yield significantly fewer positive cultures for Pseudomonas aeruginosa and other bacteria, its patients will provide significantly higher patient care satisfaction ratings, and its treatment costs will be significantly lower.

The inclusion criteria for this study are male or female new patients presenting with a partial thickness burn injury in at least two non-contiguous locations of the body; and their burn injury must have occurred within 72 hours of sustaining a burn.

Primary outcome measures are a change in wound appearance (Time frame: daily for 7 to 21 days, depending on the time it takes for the burn injury to completely heal).

table 3

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