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 Randomized, Phase 2, Double-Blind, Placebo-
Controlled Trial to Evaluate the Safety and Efficacy
of HL-009 Liposomal Gel in Adult Patients With Mild
to Moderate Atopic Dermatitis
Sponsored by HanAll BioPharma Co., Ltd., the objective of this phase
2 study is to evaluate the safety and efficacy of HL-009 Liposomal
Gel in adult patients with mild to moderate atopic dermatitis (AD).
The primary outcome measure is a core change from baseline
on IGA at Week 8.
Males or females over 18 years of age with a clinical diagnosis of
AD by a board certified/eligible dermatologist are eligible. Subjects
must have body surface area affected to at least 2% total
body surface area (BSA), with IGA score 2 or 3 corresponding to
mild to moderate AD at screening and baseline visits and be able
to give written, informed consent.
Subjects who had topical treatment with corticosteroids within 2
weeks before screening, or who had systemic treatment with corticosteroids
or ciclosporin and photopheresis treatment within 2
weeks before screening are ineligible. Subjects cannot have had
ultraviolet irradiation within 2 weeks before screening, have participated
in another drug trial within 4 weeks before screening, or
have an allergy to one of the excipients. Female subjects who have
a positive serum pregnancy test at screening, plan a pregnancy
during study period, or are breast-feeding are ineligible. Female
subjects who don't meet one of the following criteria will be excluded:
surgically sterile, post-menopausal for at least 12 months,
or if sexually active, they should use oral contraceptives, double
barrier contraception, intrauterine device, or other methods approved
by the sponsor. Subjects who have other topical treatment
of the AD area, take any systemic anti-infective or antibiotic treatment,
or have had eczema herpeticum will be ineligible. Subjects
who have any clinically significant presence of skin disease or
pigmentation other than atopic dermatitis, or wide scar on atopic
dermatitis area, have poorly controlled chronic disease, or significant
medical problems, including but not limited to uncontrolled
hypertension and congestive heart failure, are ineligible. Subjects
who have clinically significant laboratory abnormalities at
screening, a marked prolongation of QT/QTc interval at screening,
a history of additional risk factors for TdP, and/or use a medication
that prolongs the QT/QTc interval cannot participate, nor can
subjects who, in the opinion of the investigator, would be noncompliant
with the visit schedule of study procedures.
BASAL CELL CARCINOMA
A Pilot Study to Investigate the Off Label Use of
Vismodegib as an Adjuvant to Surgery for Basal
Cell Carcinoma Tumors (BCC)
Sponsored by Stanford University, the purpose of this study is
to learn about the effect of vismodegib on sporadic basal cell
carcinoma (BCCs) prior to surgical removal. Patients receive vismodegib
orally (PO), once daily (QD), for up to 3 months if the
initial BCC size is less than 2 cm and superficial or for up to 6
months if the initial BCC size is 2 cm or greater or non-superficial.
After completion of vismodegib treatment, patients undergo
Mohs surgery. After completion of study treatment, patients are
followed up for 6 months. The primary outcome measure is an
anti-tumor effect as measured by the percent change in surgical
defect area against the null hypothesis of no change after the
treatment period using calipers and photographs.
Study patients must have at least one BCC, greater than 5 mm,
be eligible for Mohs surgical removal. Patients with BCCs that
have been treated before (recurrent BCCs, BCCs that failed other
chemotherapy) are eligible for this trial if they meet size criteria.
No Eastern Cooperative Oncology Group (ECOG) or Karnofsky
performance status will be employed. Patients must have normal
hepatic function: aspartate aminotransferase (AST) and alanine
aminotransferase (ALT) equal to or less than 2 x the upper limit of
normal (ULN). Patients must have normal renal function, normal
complete blood count (CBC) and differential and the ability to
understand and the willingness to sign a written informed consent
document. The patient must be willing to forego surgical
treatment of BCCs by up to 6 months, except when the principal
investigator (PI) believes that delay in treatment potentially
might compromise the health of the subject. There must be a
documented negative serum pregnancy test for women of childbearing
potential, with agreement to the use of two acceptable
methods of contraception during the study and for 7 months
after discontinuation of vismodegib. Men with female partners
of childbearing potential must agree to use a latex, non-latex,
or any other male condom, and to advise their female partners
to use an additional acceptable method of birth control during
the study and for 2 months after discontinuation of study drug.
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