Phase 2 Study of HL-009 Liposomal Gel to Treat Mild to Moderate Atopic Dermatitis
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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 |
- Score change from baseline on IGA at Week 8 [ Time Frame: Weeks 0, 1, 2, 4, 6, and 8 ] [ Designated as safety issue: No ]
- 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 |
| Estimated Study Completion Date: | December 2012 |
| Estimated Primary Completion Date: | November 2012 (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 |
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| Contact: Hugh Lee | hjlee@hanall.co.kr |
| United States, Illinois | |
| Recruiting | |
| Arlington Heights, Illinois, United States, 60025 | |
| Contact: Hugh Lee hjlee@hanall.co.kr | |
| United States, Minnesota | |
| Recruiting | |
| Fridley, Minnesota, United States, 55432 | |
| Contact: Hugh Lee hjlee@hanall.co.kr | |
| United States, New Jersey | |
| Recruiting | |
| Berlin, New Jersey, United States, 08009 | |
| Contact: Hugh Lee hjlee@hanall.co.kr | |
| United States, North Carolina | |
| Not yet recruiting | |
| Winston-Salem, North Carolina, United States, 27157 | |
| Contact: Hugh Lee hjlee@hanall.co.kr | |
| United States, Ohio | |
| Recruiting | |
| South Euclid, Ohio, United States, 44118 | |
| Contact: Hugh Lee hjlee@hanall.co.kr | |
| United States, Oregon | |
| Recruiting | |
| Portland, Oregon, United States, 97223 | |
| Contact: Hugh Lee hjlee@hanall.co.kr | |
| United States, Texas | |
| Recruiting | |
| Austin, Texas, United States, 78759 | |
| Contact: Hugh Lee hjlee@hanall.co.kr | |
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: | October 15, 2012 |
| 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 May 23, 2013