ROSACEA
Mirvaso in Use Study
Sponsored by Galderma Laboratories, L.P., the purpose of
this study is to assess the signs and symptoms of rosacea,
including erythema, without treatment and during treatment
with Mirvaso® gel. It is also designed to further characterize
lifestyle impact and patient satisfaction with Mirvaso® treatment
and gain a better understanding of the real-world use
of Mirvaso® on the pattern and management of facial erythema
of rosacea.
Subjects must have a board certified dermatologist (BCD)
clinical diagnosis of facial erythema of rosacea and be eligible
for treatment with Mirvaso® (brirnonidine) topical gel
0.33% per package insert. They must also have a CEA score
of ~3 and fewer than 3 facial inflammatory lesions of rosacea
at screening visit 1.
Primary outcome measures are clinical erythema assessment
(Time frame: 14 days). Secondary outcomes include a subject
facial redness questionnaire, a subject treatment satisfaction
questionnaire, a facial redness VAS, and inflammatory lesions.
SKIN CANCER
Post Excision/Mohs Scar Laser Resurfacing
Sponsored by the Mount Sinai School of Medicine, this quantitative
and qualitative scar analysis study will evaluate the
potential benefits of treating a surgical scar post excision with
an ablative fractionated CO2 laser with the goal of decreasing
the appearance and size of the scar.
The objective of this research is to determine, through a split
scar study, that treating a post excision scar with a fractionated
ablative CO2 laser improves both the texture and cosmetic
appearance of the scar. An attempt will be made to determine
the ideal timing for treating the excision scar as previous studies
have ranged from treating the day of the excision up till
10 weeks post-excision. In order to evaluate the treated portion
versus untreated portion of the scar, investigators and
the subjects will use a quartile rating scale. In addition, punch
biopsy samples will be taken to quantify the difference in collagen
architecture 9 weeks after treatment with the laser.
There will be a total of 7 study visits to include the day of
the excision and laser treatment if randomized to this group,
post-op day 10 for suture removal as well as laser therapy if
the subject has been randomized to that treatment group, 4
weeks post-op, 9 weeks post-op and laser treatment for subjects
randomized to this time frame for treatment, 12 weeks
post-op, 17 weeks post-op, and 24 weeks post-op. Healing
and scar appearance will be reviewed and rated at each of
the 6 postsurgical visits.
PEDIATRIC PSORIASIS
Study Evaluating the Safety and Effectiveness of Etanercept for the Treatment of Pediatric Psoriasis
Sponsored by Pfizer, this study is a long-term, prospective,
observational cohort study of the safety and effectiveness of
Etanercept in the treatment of pediatric psoriasis patients in a
naturalistic setting. The aim of this study is to assess the safety
and effectiveness of Etanercept for the treatment of pediatric
psoriasis in Europe.
Etanercept is a biologic drug and has been licensed for the
treatment of chronic severe plaque psoriasis in children and
adolescents who are inadequately controlled by, or are intolerant
to, other systemic therapies or phototherapies. There are
limited data available about the long-term effects of etanercept
in pediatric psoriasis, especially with respect to malignancy.
Patients aged 4-17 with plaque psoriasis diagnosed by a dermatologist
will be invited to participate in the registry only after
a clinical decision has been made to prescribe Etanercept. The
safety of the drug and how well the drug works will be evaluated
during the follow-up period. The follow-up period will last
5 years and patients will be followed up every 3 months for the
first 2 years and every 6 months for the next 3 years.
