Overview

Phase 2 Study of HL-009 Liposomal Gel to Treat Mild to Moderate Atopic Dermatitis

Status:
Completed
Trial end date:
2013-08-01
Target enrollment:
0
Participant gender:
All
Summary
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).
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
HanAll BioPharma Co., Ltd.
Criteria
Inclusion Criteria:

- Males or females aged 18 or older

- Clinical diagnosis of AD by a board certified/eligible dermatologist

- Subjects who have body surface area affected to at least 2% total body surface area
(BSA)

- Subjects with IGA score 2 or 3 corresponding to mild to moderate AD at screening and
baseline visits

- Subjects who can give written informed consent

Exclusion Criteria:

- Subjects who had topical treatment with corticosteroids within 2 weeks before
screening

- Subjects who had systemic treatment with corticosteroids or ciclosporin and
photopheresis treatment within 2 weeks before screening

- Subjects who had ultraviolet irradiation within 2 weeks before screening

- Subjects who participated in another drug trial within 4 weeks before screening

- Subjects who 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

- Female subjects who don't meet one of the following criteria: Be 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

- Subjects who take any systemic anti-infective or antibiotic treatment

- Subjects who had eczema herpeticum

- Subjects who have any clinically significant presence of skin disease or pigmentation
other than atopic dermatitis, or wide scar on atopic dermatitis area

- Subjects who have poorly-controlled chronic disease

- Subjects who have significant medical problems, including but not limited to
uncontrolled hypertension and congestive heart failure

- Subjects who have clinically significant laboratory abnormalities at screening

- Subjects who have a marked prolongation of QT/QTc interval at screening

- Subjects who have a history of additional risk factors for TdP

- Subjects who use a medication that prolongs the QT/QTc interval

- Subjects who, in the opinion of the investigator, would be non-compliant with the
visit schedule of study procedures