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