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.
ROSACEA
A Single Site Evaluation of the Effect of Topical
Application of Aminocaproic Acid (ACA) to Inhibit
Kallikrein 5 Serine Protease Activity and Production
of LL-37 Cathelicidin Peptide, Biochemical Markers
of Rosacea-specific Inflammation
Sponsored by University of California, San Diego, the purpose
of this study is to determine the effect of topical aminocaproic
acid on the immune system by assessing the levels of antimicrobial
peptides in the skin of patients with rosacea. It is
hypothesized that aminocaproic acid applied topically will alter
the body's immune system in patients with rosacea by inhibiting
activation of antimicrobial peptides. The primary outcome
measure is a determination of the effect of aminocaproic acid
on the antimicrobial peptide cathelicidin in adult skin from patients
with rosacea.
Male and non-pregnant females, 18-70 years of age with mild/
moderate papulopustular rosacea (3-20 papulopustules) and at
least mild erythema are eligible. Participants must have been
on a stable dose for greater than 3 months of medications for
treatment of concurrent medical condition (including oral contraceptive
pills, vasodilators, adrenergic blocking agents) OR
the investigator has determined that the medications are unlikely
to affect the patient's rosacea and/or treatment during the
study. Subjects must be in general good health with a calculated
creatinine clearance 100% of normal range. Subjects must
have normal baseline labs or in the opinion of the investigator
are values are not clinically significant and would not inhibit
the ability to monitor the patient for both safety and efficacy
throughout the study.
Subjects cannot have a diagnosis of Steroid Rosacea or Pyoderma
Faciale (rosacea fulminans) or a history of Carcinoid,
Pheochromocytoma, Serotonin Syndrome, or other systemic
flushing causes. Subjects cannot have used facial topical therapies
(OTC drug products or prescription products) for any reason
within the prior 28 days, or systemic corticosteroid or systemic
antibiotics (especially doxycycline, minocycline, tetracycline,
metronidazole) within the prior 28 days. Subjects cannot have
laser or light-based treatment for rosacea within the prior 3
months, systemic retinoids and retinoid derivatives over the past
6 months or active or recent history of any coagulation (hyper
or hypo) disorder, genitourinary bleeding, myopathy, cardiomyopathy,
rhabdomyolysis, or evidence of clinically significant
hepatic disease in the opinion of the investigator. Subjects cannot be taking any medicines or supplements that interfere with
blood clotting such as Coumadin, Plavix, or ASA (>81mg/day),
have a known hypersensitivity or allergy to aminocaproic acid or
components of the vehicle, be pregnant or lactating or planning
a pregnancy during the duration of the study. Subjects cannot
have been treated with another investigational device or drug
within 28 days prior to study enrollment or intends to participate
in a clinical trial concurrent with this study, nor can subjects
have clinically significant findings, medical history, or conditions
(other than rosacea) that in the opinion of the Investigator may
compromise the study, treatment protocol, or safety of the patient
or treatment allocation.
ROSACEA
Comparison of the Efficacy Between Pulsed Dye Laser
(PDL) and the Microsecond 1064-nm Nd:YAG Laser for
Treatment of Diffuse Facial Redness: A Pilot, Prospective
Randomized Trial
Sponsored by Northwestern University, the objective of this
study is to compare the efficacy of PDL and the 1064-nm
Nd:YAG laser in the treatment of facial redness. The primary
objective of this study is to compare the efficacy of PDL and the
1064-nm Nd:YAG laser in the treatment of facial redness.
Healthy patients 18-55 years of age with erythematotelangiectatic
rosacea (as verified by the PI) are eligible.
Subjects cannot be pregnant or lactating, unable to understand
the protocol or to give informed consent, have a known history
of photosensitive conditions (eg, systemic lupus, polymorphous
light eruption), facial telangiectasia of diameter greater than 2
mm or significant (as determined by the PI) acute inflammatory
papules, pustules, and vesicles involving the central face.
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