CLINICAL TRIAL REVIEW

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.

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.