Clinical Trial Report
June 2015 | Volume 14 | Issue 6 | Features | 643 | Copyright © June 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.
ADVANCED STAGE MELANOMA
Immunotherapy Study for Patients With Stage IV Melanoma
Sponsored by NewLink Genetics Corporation, the main objective
of this study is to determine the safety and clinical response
rate of the administration of ipilimumab with or without HyperAcute ® Melanoma (HAM) immunotherapy for patients with
stage IV, metastatic melanoma.
Despite the best clinical efforts and breakthroughs in biotechnology,
most patients diagnosed with advanced stage melanoma
continue to die from their disease. Resistance to one type of
chemotherapy often rapidly leads to resistance to many other
chemotherapy drugs. These major causes of cancer progression
are usually discussed when considering treatment options
for patients with a disease that continues to grow and spread.
However, another important part of the body should also be
considered – the immune system. This human clinical trial proposes
a new way to make the immune system recognize the
cancer cells, and encourages it to attack and destroy them.
Patients who have known stage IV, metastatic melanoma who
have known stage IV, metastatic melanoma are given 4 injections
of ipilimumab 3 weeks apart x 4 injections with or without
HAM immunotherapy. The investigators hypothesize that
compared with the use of ipilimumab alone, this form of combinatorial
immunotherapy will result in tumor stabilization or
shrinkage, as well as a significant prolongation of progressionfree,
disease-free, or overall survival.
SKIN OF COLOR CLINICS
Black Patients' Lived Experiences and Perceptions of Skin of Color Clinics
Across the USA, Skin of Color (SOC) clinics have been established
with the goal of providing medical care and supporting
research related to patients with skin of color. There have been
no formal studies evaluating why patients seek medical care at
SOC clinics, or treatment outcomes. Reasons may include past
experiences with other providers, the perception that providers
working in these clinics have a special interest or knowledge
in caring for patients with skin of color, the expectation of cultural
sensitivity, the hope that their provider may have a similar
ethnic background, and/or ease of communication with their
provider. Through focus group discussions, the study aims to
identify the factors influencing a patient's choice to seek medical
care at a SOC clinic and to gain insight into the presence and
impact of racial concordance between provider and patient.
The current study will focus on self-identified African American
patients, with an interest in conducting similar sessions with
patients of other ethnicities and races in the future.
Transcripts of focus group discussions will be transcribed and
then analyzed via a “long-hand” inductive approach by 2 dermatologists
and 1 psychologist. For each of the 8 posed focus
group questions, the reviewers will independently induce a
common thematic response.
CD5789 Long Term Safety Study on Acne Vulgaris
This is a multi-center, open-label, non-comparative safety
and efficacy study with 52 weeks of treatment on the face
and trunk for acne vulgaris. Its purpose is to determine the
safety and efficacy of CD5789 50 μg/g cream in the longterm
treatment of subjects with acne vulgaris. Efficacy will
be evaluated as a secondary objective. Assessment of local
tolerability and adverse events will be assessed at each visit
in a timeframe of up to 52 weeks.
To be included in the study, the subject must have a facial
acne severity grade of IGA grade 3 (moderate) and a minimum
of 20 inflammatory lesions and 25 non-inflammatory lesions
at screening and baseline visits. Alternatively, he/she must