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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
HanAll BioPharma Co., Ltd.
ClinicalTrials.gov Identifier:
NCT01568489
First received: March 29, 2012
Last updated: February 24, 2014
Last verified: February 2014
  Purpose

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).


Condition Intervention Phase
Mild to Moderate Atopic Dermatitis
Drug: HL-009 Liposomal Gel
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
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

Further study details as provided by HanAll BioPharma Co., Ltd.:

Primary Outcome Measures:
  • Score change from baseline on IGA at Week 8 [ Time Frame: Weeks 0, 1, 2, 4, 6, and 8 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • Score change from baseline on EASI at Week 8 [ Time Frame: Weeks 0, 1, 2, 4, 6, and 8 ] [ Designated as safety issue: No ]
  • Score change from baseline on VAS for pruritus at Week 8 [ Time Frame: Weeks 0, 1, 2, 4, 6, and 8 ] [ Designated as safety issue: No ]
  • Score change from baseline on DLQI at Week 8 [ Time Frame: Weeks 0, 1, 2, 4, 6, and 8 ] [ Designated as safety issue: No ]
  • Score change from baseline on SF-36 questionnaires at Week 8 [ Time Frame: Weeks 0, 4, and 8 ] [ Designated as safety issue: No ]

Estimated Enrollment: 120
Study Start Date: March 2012
Study Completion Date: August 2013
Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01568489

Locations
United States, Illinois
Arlington Heights, Illinois, United States, 60025
United States, Minnesota
Fridley, Minnesota, United States, 55432
United States, New Jersey
Berlin, New Jersey, United States, 08009
United States, North Carolina
Winston-Salem, North Carolina, United States, 27157
United States, Ohio
South Euclid, Ohio, United States, 44118
United States, Oregon
Portland, Oregon, United States, 97223
United States, Texas
Austin, Texas, United States, 78759
Sponsors and Collaborators
HanAll BioPharma Co., Ltd.
  More Information

No publications provided

Responsible Party: HanAll BioPharma Co., Ltd.
ClinicalTrials.gov Identifier: NCT01568489     History of Changes
Other Study ID Numbers: HL-009-ADP2-US-01
Study First Received: March 29, 2012
Last Updated: February 24, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Dermatitis
Dermatitis, Atopic
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases

ClinicalTrials.gov processed this record on August 28, 2014