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

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

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).

Study Overview

• Status: Completed
• Conditions: Mild to Moderate Atopic Dermatitis
• Intervention / Treatment: Drug: HL-009 Liposomal Gel

Detailed Description

This is a randomized, double-blind, placebo-controlled, parallel-group comparison study in subjects with mild to moderate AD. Following a 2-week screening period, subjects will be randomly assigned into one of four treatment arms. Placebo or HL-009 study treatments will be administrated to subjects twice daily for 8 consecutive weeks. After the randomization at Week 0 (Visit 2), subjects will visit their respective trial sites at Weeks 0.5, 1, 2, 4, 6, 8, and 10 (Visits 3, 4, 5, 6, 7, 8, and 9). All study drugs will be in identical laminated tubes to preserve double-blinding of the study.

• Study Type: Interventional
• Enrollment (Actual): 120
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Arlington Heights, Illinois, United States, 60025
  • Minnesota
    • Fridley, Minnesota, United States, 55432
  • New Jersey
    • Berlin, New Jersey, United States, 08009
  • North Carolina
    • Winston-Salem, North Carolina, United States, 27157
  • Ohio
    • South Euclid, Ohio, United States, 44118
  • Oregon
    • Portland, Oregon, United States, 97223
  • Texas
    • Austin, Texas, United States, 78759

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: HL-009 Liposomal Gel (0.07%)	Drug: HL-009 Liposomal Gel; a semi-transparent red-color gel and is supplied as a laminated tube
EXPERIMENTAL: HL-009 Liposomal Gel (0.15%)	Drug: HL-009 Liposomal Gel; a semi-transparent red-color gel and is supplied as a laminated tube
EXPERIMENTAL: HL-009 Liposomal Gel (0.30%)	Drug: HL-009 Liposomal Gel; a semi-transparent red-color gel and is supplied as a laminated tube
PLACEBO_COMPARATOR: HL-009 Liposomal Gel (Placebo)	Drug: HL-009 Liposomal Gel; a semi-transparent red-color gel and is supplied as a laminated tube

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Score change from baseline on IGA at Week 8	Weeks 0, 1, 2, 4, 6, and 8

Secondary Outcome Measures

Outcome Measure	Time Frame
Percentage of subjects who have a minimum of 2-point improvement in IGA score at Week 8	Weeks 0, 1, 2, 4, 6, and 8
Score change from baseline on EASI at Week 8	Weeks 0, 1, 2, 4, 6, and 8
Score change from baseline on VAS for pruritus at Week 8	Weeks 0, 1, 2, 4, 6, and 8
Score change from baseline on DLQI at Week 8	Weeks 0, 1, 2, 4, 6, and 8
Score change from baseline on SF-36 questionnaires at Week 8	Weeks 0, 4, and 8

Collaborators and Investigators

• Sponsor: HanAll BioPharma Co., Ltd.

Study record dates

Study Major Dates

• Study Start: March 1, 2012
• Primary Completion (ACTUAL): August 1, 2013
• Study Completion (ACTUAL): August 1, 2013

Study Registration Dates

• First Submitted: March 29, 2012
• First Submitted That Met QC Criteria: March 30, 2012
• First Posted (ESTIMATE): April 2, 2012

Study Record Updates

• Last Update Posted (ESTIMATE): September 23, 2015
• Last Update Submitted That Met QC Criteria: September 21, 2015
• Last Verified: September 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Immune System Diseases; Hypersensitivity, Immediate; Genetic Diseases, Inborn; Skin Diseases, Genetic; Hypersensitivity; Skin Diseases, Eczematous; Dermatitis; Eczema; Dermatitis, Atopic
• Other Study ID Numbers: HL-009-ADP2-US-01