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

NCT01568489 | Completed Phase 2

• 1 other identifier: HL-009-ADP2-US-01
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 7

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).

Conditions

Mild to Moderate Atopic Dermatitis

Outcome Measures

Primary Outcomes (1)

• Score change from baseline on IGA at Week 8

  Weeks 0, 1, 2, 4, 6, and 8

Secondary Outcomes (5)

• 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

Study Arms (4)

HL-009 Liposomal Gel (0.07%)

EXPERIMENTAL

Administer topically twice a day for 8 consecutive weeks.

Drug: HL-009 Liposomal Gel

HL-009 Liposomal Gel (0.15%)

EXPERIMENTAL

Administer topically twice a day for 8 consecutive weeks.

Drug: HL-009 Liposomal Gel

HL-009 Liposomal Gel (0.30%)

EXPERIMENTAL

Administer topically twice a day for 8 consecutive weeks.

Drug: HL-009 Liposomal Gel

HL-009 Liposomal Gel (Placebo)

PLACEBO COMPARATOR

Administer topically twice a day for 8 consecutive weeks.

Drug: Placebo

Interventions

HL-009 Liposomal Gel DRUG

Topical adenosylcobalamin gel

HL-009 Liposomal Gel (0.07%); HL-009 Liposomal Gel (0.15%); HL-009 Liposomal Gel (0.30%)

Placebo DRUG

Placebo gel

HL-009 Liposomal Gel (Placebo)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• HanAll BioPharma Co., Ltd.: lead

Study Sites (7)

Unknown Facility

Arlington Heights, Illinois, 60025, United States

Location

Unknown Facility

Fridley, Minnesota, 55432, United States

Location

Unknown Facility

Berlin, New Jersey, 08009, United States

Location

Unknown Facility

Winston-Salem, North Carolina, 27157, United States

Location

Unknown Facility

South Euclid, Ohio, 44118, United States

Location

Unknown Facility

Portland, Oregon, 97223, United States

Location

Unknown Facility

Austin, Texas, 78759, United States

Location

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 29, 2012
• First Posted: April 2, 2012
• Study Start: April 9, 2012
• Primary Completion: June 11, 2013
• Study Completion: June 11, 2013
• Last Updated: April 22, 2025

Record last verified: 2015-09

Locations

US (7)