Overview
Phase 2 Study of HL-009 Liposomal Gel to Treat Mild to Moderate Atopic Dermatitis
Status:
Completed
Completed
Trial end date:
2013-08-01
2013-08-01
Target enrollment:
0
0
Participant gender:
All
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 2Accepts Healthy Volunteers?
NoDetails
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