A Clinical Outcomes Protocol of Photon/Proton Beam Radiation Therapy for Carcinoma of the Skin of the Head and Neck With Perineural Invasion
This study is sponsored by the University of Florida. The
purpose is to collect information from the questionnaire and
your medical records to see what effects the proton radiation
has on you and your cancer and collect and analyze morbidity
outcomes: Incidence of xerostomia (dry mouth) and
tumor control.
The primary outcome measure is to Collect and analyze morbidity
outcomes: Incidence of grade 3 or higher xerostomia
(dry mouth). Time Frame: 1 year following the completion of
radiation therapy. The secondary outcome measure is to collect
and analyze tumor control outcomes.
To be considered for this study, the patient must be 18 years of
age or older; have carcinoma of the skin of the head and neck
region with incidental or symptomatic perineural invasion
or biopsy-proven squamous cell carcinoma, and will receive
treatment with proton radiation.
A Phase 3b, Multicenter, Randomized, Placebo- Controlled, Double Blind, Double-Dummy Study of the Efficacy and Safety of Apremilast (CC- 10004), Etanercept, and Placebo, in Subjects With Moderate to Severe Plaque Psoriasis
This study, sponsored by Celgene Corporation, will test the
clinical effectiveness and safety of apremilast, etanercept
compared with placebo in the same group of patients with
moderate to severe plaque psoriasis. Apremilast (CC-10004)
is a new oral agent that is under clinical development for the
treatment of inflammatory autoimmune disorders, such as
psoriatic arthritis, psoriasis, rheumatoid arthritis, and Behçet
disease. Etanercept is approved for the treatment of psoriasis;
it is the most widely prescribed anti-tumor necrosis
factor (TNF) for psoriasis.
The primary outcomes are Apremilast Psoriasis Area and Severity
Index-75 (PASI), time frame: Week 16. Proportion of subjects
with either apremilast 30 mg twice a day (BID) or placebo who
achieve at least a 75% reduction in PASI (PASI-75) at Week 16 from
baseline in subjects with plaque type psoriasis or plaque psoriasis
Inclusion Criteria: are males or females, ≥ 18 years of age; diagnosis
of chronic, moderate to severe plaque psoriasis for at
least 12 months prior to screening, and a candidate for phototherapy
and/or systemic (including etanercept) therapy;
received an inadequate response, intolerance, or contraindication
to at least 1 conventional systemic agent for the treatment
of psoriasis; no prior exposure to biologics for treatment of
psoriatic arthritis or psoriasis
Revlite Laser System Compared to the Candela Alex TriVantage System Refractory Mixed Type Melasma
This proof of concept study, sponsored by Cynosure, Inc, will
be conducted to assess the aesthetic improvement in refractory
mixed type melasma in subjects treated with two FDA 510K approved
devices: Q Switched Nd: YAG Laser vs. Alex TriVantage.
Primary outcomes are live assessment of aesthetic levels of
improvement using Global Aesthetic Improvement Scale by
PI at 1 and 3 months with time frame up to 3 months post
last treatment.
To be considered for this study, patients must be subjects with
Fitzpatrick Skin Type III-VI or mixed (epidermal and dermal)
type melasma diagnosed by Wood's Lamp; subjects who are
over the age of 18 years of age; willing and able to comply
with study instructions and return to the clinic for required visits;
and the subject's melasma has persisted for greater than
6 months and has failed to respond to conventional treatment
with hydroquinone cream or other topical lightening agents.
