Back to resultsPhase 2 Study of HL-009 Liposomal Gel to Treat Mild to Moderate Atopic Dermatitis
Primary Purpose
Mild to Moderate Atopic Dermatitis
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
HL-009 Liposomal Gel
Sponsored by
About this trial
This is an interventional treatment trial for Mild to Moderate Atopic Dermatitis
Eligibility 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Placebo Comparator
Arm Label
HL-009 Liposomal Gel (0.07%)
HL-009 Liposomal Gel (0.15%)
HL-009 Liposomal Gel (0.30%)
HL-009 Liposomal Gel (Placebo)
Arm Description
Outcomes
Primary Outcome Measures
Score change from baseline on IGA at Week 8
Secondary Outcome Measures
Percentage of subjects who have a minimum of 2-point improvement in IGA score at Week 8
Score change from baseline on EASI at Week 8
Score change from baseline on VAS for pruritus at Week 8
Score change from baseline on DLQI at Week 8
Score change from baseline on SF-36 questionnaires at Week 8
Full Information
NCT ID
NCT01568489
First Posted
March 29, 2012
Last Updated
September 21, 2015
Sponsor
HanAll BioPharma Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT01568489
Brief Title
Phase 2 Study of HL-009 Liposomal Gel to Treat Mild to Moderate Atopic Dermatitis
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
September 2015
Overall Recruitment Status
Completed
Study Start Date
March 2012 (undefined)
Primary Completion Date
August 2013 (Actual)
Study Completion Date
August 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
HanAll BioPharma Co., Ltd.
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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).
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mild to Moderate Atopic Dermatitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
120 (Actual)
8. Arms, Groups, and Interventions
Arm Title
HL-009 Liposomal Gel (0.07%)
Arm Type
Experimental
Arm Title
HL-009 Liposomal Gel (0.15%)
Arm Type
Experimental
Arm Title
HL-009 Liposomal Gel (0.30%)
Arm Type
Experimental
Arm Title
HL-009 Liposomal Gel (Placebo)
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
HL-009 Liposomal Gel
Intervention Description
a semi-transparent red-color gel and is supplied as a laminated tube
Primary Outcome Measure Information:
Title
Score change from baseline on IGA at Week 8
Time Frame
Weeks 0, 1, 2, 4, 6, and 8
Secondary Outcome Measure Information:
Title
Percentage of subjects who have a minimum of 2-point improvement in IGA score at Week 8
Time Frame
Weeks 0, 1, 2, 4, 6, and 8
Title
Score change from baseline on EASI at Week 8
Time Frame
Weeks 0, 1, 2, 4, 6, and 8
Title
Score change from baseline on VAS for pruritus at Week 8
Time Frame
Weeks 0, 1, 2, 4, 6, and 8
Title
Score change from baseline on DLQI at Week 8
Time Frame
Weeks 0, 1, 2, 4, 6, and 8
Title
Score change from baseline on SF-36 questionnaires at Week 8
Time Frame
Weeks 0, 4, and 8
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
City
Arlington Heights
State/Province
Illinois
ZIP/Postal Code
60025
Country
United States
City
Fridley
State/Province
Minnesota
ZIP/Postal Code
55432
Country
United States
City
Berlin
State/Province
New Jersey
ZIP/Postal Code
08009
Country
United States
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
City
South Euclid
State/Province
Ohio
ZIP/Postal Code
44118
Country
United States
City
Portland
State/Province
Oregon
ZIP/Postal Code
97223
Country
United States
City
Austin
State/Province
Texas
ZIP/Postal Code
78759
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Phase 2 Study of HL-009 Liposomal Gel to Treat Mild to Moderate Atopic Dermatitis
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