Mild to Moderate Atopic DermatitisPhase 2NCT01568489
Phase 2 Study of HL-009 Liposomal Gel to Treat Mild to Moderate Atopic Dermatitis
A Phase 2 study testing HL-009 Liposomal Gel in people with Mild to Moderate Atopic Dermatitis, run by HanAll BioPharma Co., Ltd. at 7 sites in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mild to Moderate Atopic Dermatitis
- What is being tested?
- HL-009 Liposomal Gel
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 7 sitesUnited States
- Study dates
- 9 Apr 2012to 11 Jun 2013
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 18Show fewer
- 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
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
Study site
Arlington Heights, Illinois, 60025
Study site
Austin, Texas, 78759
Study site
Berlin, New Jersey, 08009
Study site
Fridley, Minnesota, 55432
Study site
Portland, Oregon, 97223
Study site
South Euclid, Ohio, 44118
Study site
Winston-Salem, North Carolina, 27157
About this study
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
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).
Read the 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
- Being tested
- HL-009 Liposomal Gel, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HL-009 Liposomal GelDrug
Topical adenosylcobalamin gel
PlaceboDrug
Placebo gel
| Study group | Role | What they receive |
|---|---|---|
| HL-009 Liposomal Gel (0.07%) | Experimental | Administer topically twice a day for 8 consecutive weeks. Receives: Drug: HL-009 Liposomal Gel |
| HL-009 Liposomal Gel (0.15%) | Experimental | Administer topically twice a day for 8 consecutive weeks. Receives: Drug: HL-009 Liposomal Gel |
| HL-009 Liposomal Gel (0.30%) | Experimental | Administer topically twice a day for 8 consecutive weeks. Receives: Drug: HL-009 Liposomal Gel |
| HL-009 Liposomal Gel (Placebo) | Placebo comparator | Administer topically twice a day for 8 consecutive weeks. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Score change from baseline on IGA at Week 8
Measured: 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
Measured: Weeks 0, 1, 2, 4, 6, and 8
Score change from baseline on EASI at Week 8
Measured: Weeks 0, 1, 2, 4, 6, and 8
Score change from baseline on VAS for pruritus at Week 8
Measured: Weeks 0, 1, 2, 4, 6, and 8
Score change from baseline on DLQI at Week 8
Measured: Weeks 0, 1, 2, 4, 6, and 8
Score change from baseline on SF-36 questionnaires at Week 8
Measured: Weeks 0, 4, and 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2012 (estimated)
- Study start9 Apr 2012
- Primary completion11 Jun 2013
- Study completion11 Jun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mild to Moderate Atopic DermatitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- HanAll BioPharma Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01568489
- Sponsor's protocol ID
- HL-009-ADP2-US-01
- Status last verified
- Sep 2015
- First submitted
- 29 Mar 2012
- Last updated
- 22 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01568489
- Acronym / sponsor ID
- HL-009-ADP2-US-01
- Conditions
- Mild to Moderate Atopic Dermatitis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- HanAll BioPharma Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 9 Apr 2012 (actual)
- Primary completion
- 11 Jun 2013 (actual)
- Study completion
- 11 Jun 2013 (actual)
- First posted
- 2 Apr 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| HL-009 Liposomal Gel (0.07%) | Experimental | Drug: HL-009 Liposomal GelAdminister topically twice a day for 8 consecutive weeks. |
| HL-009 Liposomal Gel (0.15%) | Experimental | Drug: HL-009 Liposomal GelAdminister topically twice a day for 8 consecutive weeks. |
| HL-009 Liposomal Gel (0.30%) | Experimental | Drug: HL-009 Liposomal GelAdminister topically twice a day for 8 consecutive weeks. |
| HL-009 Liposomal Gel (Placebo) | Placebo comparator | Drug: PlaceboAdminister topically twice a day for 8 consecutive weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (18 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HL-009 Liposomal GelTopical adenosylcobalamin gel | Drug | HL-009 Liposomal Gel (0.07%), HL-009 Liposomal Gel (0.15%), HL-009 Liposomal Gel (0.30%) |
| PlaceboPlacebo gel | Drug | HL-009 Liposomal Gel (Placebo) |
Primary outcome
Score change from baseline on IGA at Week 8
Time frame: Weeks 0, 1, 2, 4, 6, and 8
5 secondary outcomes
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
Score change from baseline on EASI at Week 8
Time frame: Weeks 0, 1, 2, 4, 6, and 8
Score change from baseline on VAS for pruritus at Week 8
Time frame: Weeks 0, 1, 2, 4, 6, and 8
Score change from baseline on DLQI at Week 8
Time frame: Weeks 0, 1, 2, 4, 6, and 8
Score change from baseline on SF-36 questionnaires at Week 8
Time frame: Weeks 0, 4, and 8
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing HL-009 Liposomal Gel in people with Mild to Moderate Atopic Dermatitis, run by HanAll BioPharma Co., Ltd. at 7 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Score change from baseline on IGA at Week 8 (time frame: Weeks 0, 1, 2, 4, 6, and 8). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2025.