Atopic DermatitisPhase 2NCT02757729
A Study to Evaluate the Safety and Efficacy of PAC-14028 Cream in Adults With Atopic Dermatitis
A Phase 2 study testing PAC-14028 cream 0.1%, PAC-14028 cream 0.3% and PAC-14028 cream 1.0% in people with Atopic Dermatitis, run by Amorepacific Corporation at 1 site in South Korea.
Trial summary
This is a phase 2 study to investigate the safety and efficacy of PAC-14028 cream in Atopic Dermatitis patients. Read more about this study
- Who is it for?
- Ages 19 to 70 years
- Conditions the study is for
- Atopic Dermatitis
- What is being tested?
- PAC-14028 cream 0.1%, PAC-14028 cream 0.3% and PAC-14028 cream 1.0%
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 192 participants
- Where
- 1 siteSouth Korea
- Study dates
- Oct 2015to Aug 2016
- 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 19 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and female patients aged 19 - 70 years.
- Who was diagnosed with Atopic Dermatitis according to Haniffin and Rajka criteria.
- Whose affected BSA is over 5% and IGA score is 2 (mild) to 3 (moderate).
- Who voluntarily agreed to participate in the study and signed an informed consent form.
Who cannot join
- Who has skin diseases other than atopic dermatitis or scar in the affected area which can affect the study, determined by the study investigators.
- Who has clinically significant medical history or diseases involving liver, kidney, neurological system, psychical disorder that can affect study results.
- Who has used systemic steroids, antibiotics, immunosuppressants, or received photochemical therapy within 28 days before study drug administration.
- Who has used topical steroids, immunosuppressants or antibiotics to treat atopic dermatitis within 14 days before study drug administration.
- Who has used or is expected to inevitably use prohibited concomitant medications during the study.
- Women who is pregnant /breast-feeding, or who has childbearing potential and does not use available contraceptives.
- Who has dosed other study medications within 30 days before screening.
- Who is determined ineligible for study participation by investigators for any other reasons.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Multi Center, Randomized, Double-blind, Placebo-controlled Parallel-group, Phase II Clinical Trial to Evaluate the Safety and Efficacy of PAC-14028 Cream in Mild to Moderate Atopic Dermatitis Patients
This is a phase 2 study to investigate the safety and efficacy of PAC-14028 cream in Atopic Dermatitis patients.
Read the detailed description
PAC-14028 Cream (0.1%, 0.3%, 1.0%) or placebo will be treated to Mild to Moderate Atopic Dermatitis patients twice daily for 8 weeks.
- Conditions
- Atopic Dermatitis
- Being tested
- PAC-14028 cream 0.1%, PAC-14028 cream 0.3%, PAC-14028 cream 1.0%, PAC-14028 cream vehicle
- Medical subject headings
- Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PAC-14028 cream 0.1%Drug
Topical application
PAC-14028 cream 0.3%Drug
Topical application
PAC-14028 cream 1.0%Drug
Topical application
PAC-14028 cream vehicleDrug
Topical application
| Study group | Role | What they receive |
|---|---|---|
| PAC-14028 cream 0.1% | Experimental | PAC-14028 cream 0.1%, Twice daily for 8 weeks Receives: Drug: PAC-14028 cream 0.1% |
| PAC-14028 cream 0.3% | Experimental | PAC-14028 cream 0.3%, Twice daily for 8 weeks Receives: Drug: PAC-14028 cream 0.3% |
| PAC-14028 cream 1.0% | Experimental | PAC-14028 cream 1.0%, Twice daily for 8 weeks Receives: Drug: PAC-14028 cream 1.0% |
| PAC-14028 cream vehicle | Placebo comparator | PAC-14028 cream vehicle, Twice daily for 8 weeks Receives: Drug: PAC-14028 cream vehicle |
What is being measured
The primary outcome is the main question the study is designed to answer.
Success rate of Investigator's Global Assessment (IGA)
percent of patients with IGA score of 0 (clear) or 1 (almost clear)
Measured: 8 weeks
Secondary outcomes (4)
Success rate of Investigator's Global Assessment (IGA)
percent of patients with IGA score of 0 (clear) or 1 (almost clear)
Measured: 1, 3, 6 week(s)
Change in SCORAD (Severity Score of Atopic Dermatitis)
Measured: 1, 3, 6, 8 week(s)
% Change in Eczema Area and Severity Index (EASI)
Measured: 1, 3, 6, 8 week(s)
Success rate of Pruritus Severity score
Measured: 1, 3, 6, 8 week(s)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2016 (estimated)
- Study startOct 2015
- Primary completionAug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 192 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amorepacific Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Beomjoon Kim, MD, PhD, Principal investigator, Chung-Ang University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02757729
- Sponsor's protocol ID
- AP-TRPV1-PII_04
- Status last verified
- Sep 2016
- First submitted
- 20 Apr 2016
- Last updated
- 20 Sep 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi Center, Randomized, Double-blind, Placebo-controlled Parallel-group, Phase II Clinical Trial to Evaluate the Safety and Efficacy of PAC-14028 Cream in Mild to Moderate Atopic Dermatitis Patients
- ClinicalTrials.gov ID
- NCT02757729
- Acronym / sponsor ID
- AP-TRPV1-PII_04
- Conditions
- Atopic Dermatitis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 192 participants (actual)
- Lead sponsor
- Amorepacific CorporationIndustry (pharma, biotech, devices)
- Study start
- Oct 2015
- Primary completion
- Aug 2016 (actual)
- First posted
- 2 May 2016 (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.
This is a phase 2 study to investigate the safety and efficacy of PAC-14028 cream in Atopic Dermatitis patients.
Detailed description
PAC-14028 Cream (0.1%, 0.3%, 1.0%) or placebo will be treated to Mild to Moderate Atopic Dermatitis patients twice daily for 8 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| PAC-14028 cream 0.1% | Experimental | Drug: PAC-14028 cream 0.1%PAC-14028 cream 0.1%, Twice daily for 8 weeks |
| PAC-14028 cream 0.3% | Experimental | Drug: PAC-14028 cream 0.3%PAC-14028 cream 0.3%, Twice daily for 8 weeks |
| PAC-14028 cream 1.0% | Experimental | Drug: PAC-14028 cream 1.0%PAC-14028 cream 1.0%, Twice daily for 8 weeks |
| PAC-14028 cream vehicle | Placebo comparator | Drug: PAC-14028 cream vehiclePAC-14028 cream vehicle, Twice daily for 8 weeks |
Who may qualify
- Ages
- 19 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male and female patients aged 19 - 70 years.
- Who was diagnosed with Atopic Dermatitis according to Haniffin and Rajka criteria.
- Whose affected BSA is over 5% and IGA score is 2 (mild) to 3 (moderate).
- Who voluntarily agreed to participate in the study and signed an informed consent form.
Key exclusion criteria (8 listed)
- Who has skin diseases other than atopic dermatitis or scar in the affected area which can affect the study, determined by the study investigators.
- Who has clinically significant medical history or diseases involving liver, kidney, neurological system, psychical disorder that can affect study results.
- Who has used systemic steroids, antibiotics, immunosuppressants, or received photochemical therapy within 28 days before study drug administration.
- Who has used topical steroids, immunosuppressants or antibiotics to treat atopic dermatitis within 14 days before study drug administration.
- Who has used or is expected to inevitably use prohibited concomitant medications during the study.
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 |
|---|---|---|
| PAC-14028 cream 0.1%Topical application | Drug | PAC-14028 cream 0.1% |
| PAC-14028 cream 0.3%Topical application | Drug | PAC-14028 cream 0.3% |
| PAC-14028 cream 1.0%Topical application | Drug | PAC-14028 cream 1.0% |
| PAC-14028 cream vehicleTopical application | Drug | PAC-14028 cream vehicle |
Primary outcome
Success rate of Investigator's Global Assessment (IGA)
Time frame: 8 weeks
percent of patients with IGA score of 0 (clear) or 1 (almost clear)
4 secondary outcomes
Success rate of Investigator's Global Assessment (IGA)
Time frame: 1, 3, 6 week(s)
Change in SCORAD (Severity Score of Atopic Dermatitis)
Time frame: 1, 3, 6, 8 week(s)
% Change in Eczema Area and Severity Index (EASI)
Time frame: 1, 3, 6, 8 week(s)
Success rate of Pruritus Severity score
Time frame: 1, 3, 6, 8 week(s)
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 20 Sep 2016.
- Individual participant dataSharing planned: No
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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.
Beomjoon Kim, MD, PhD principal investigator
Chung-Ang University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing PAC-14028 cream 0.1%, PAC-14028 cream 0.3% and PAC-14028 cream 1.0% in people with Atopic Dermatitis, run by Amorepacific Corporation at 1 site in South Korea.
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 4 inclusion and 8 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 20 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. 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?
Success rate of Investigator's Global Assessment (IGA) (time frame: 8 weeks). 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 20 Sep 2016.