Clinical Trial Report
April 2015 | Volume 14 | Issue 4 | Features | 424 | Copyright © April 2015
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 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).
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.
A Comparison of Medihoney
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).