NCT01568489

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 120 (actual)
• Sponsor: HanAll BioPharma Co., Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Mild to Moderate Atopic Dermatitis

Interventions

Type	Name	Description
DRUG	HL-009 Liposomal Gel	Topical adenosylcobalamin gel
DRUG	Placebo	Placebo gel

Timeline

• Start date: 2012-04-09
• Primary completion: 2013-06-11
• Completion: 2013-06-11
• First posted: 2012-04-02
• Last updated: 2025-04-22

Locations

7 sites across 1 country: United States