Atopic DermatitisPhase 1/2NCT02748993
A Study to Evaluate the Safety and Efficacy of PAC-14028 Cream in Pediatric Atopic Dermatitis
A Phase 1/2 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 3 sites in South Korea.
Trial summary
This is a phase 1 and 2 study to assess the safety and efficacy of PAC-14028 cream in children with atopic dermatitis. Read more about this study
- Who is it for?
- Ages 24 months to 12 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
- 56 participants
- Where
- 3 sitesSouth Korea
- Study dates
- Mar 2016to Oct 2018
- Phase
- Phase 1/2
- 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 24 months to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Male and female patients aged 24 months - 12 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 has applied stable amount of emollients daily before baseline visit
- 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, psychial 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
3 sites in 1 country.
South Korea3 sites
Chung-ang University Hospital
Seoul
Konkuk University Hospital
Seoul
Seoul National University Hospital
Seoul
About this study
Official title: A Randomized, Double-blind, Placebo-Controlled, Parallel Study to Investigate the Safety, Tolerability, Systemic Exposure and Efficacy of PAC-14028 in Children With Mild to Moderate Pediatric Atopic Dermatitis
This is a phase 1 and 2 study to assess the safety and efficacy of PAC-14028 cream in children with atopic dermatitis.
- 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 4 weeks Receives: Drug: PAC-14028 Cream 0.1% |
| PAC-14028 Cream 0.3% | Experimental | PAC-14028 Cream 0.3%, Twice daily for 4 weeks Receives: Drug: PAC-14028 Cream 0.3% |
| PAC-14028 Cream 1.0% | Experimental | PAC-14028 Cream 1.0%, Twice daily for 4 weeks Receives: Drug: PAC-14028 Cream 1.0% |
| PAC-14028 Cream Vehicle | Placebo comparator | PAC-14028 Cream Vehicle, twice daily for 4 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)
% of patients with IGA score of 0 (clear) or 1 (almost clear)
Measured: 4 weeks
Blood concentrations of PAC-14028
Blood concentrations of PAC-14028
Measured: Day 1, Day 28
Secondary outcomes (4)
Change of IGA (Investigator's Global Assessment)
Change of IGA score from baseline
Measured: 1, 2, 4 week(s)
Change of SCORAD (Severity Scoring of Atopic Dermatitis)
Change of SCORAD from baseline
Measured: 1, 2, 4 week(s)
% Change of EASI (Eczema Area and Severity Index)
Measured: 1, 2, 4 week(s)
Patient satisfaction measurement
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2016 (estimated)
- Study startMar 2016
- Primary completionSep 2018
- Study completionOct 2018
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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amorepacific Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kyuhan Kim, MD, PhD, Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02748993
- Sponsor's protocol ID
- AP-TRPV1_PII-05
- Status last verified
- Nov 2018
- First submitted
- 20 Apr 2016
- Last updated
- 20 Nov 2018
- 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 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-Controlled, Parallel Study to Investigate the Safety, Tolerability, Systemic Exposure and Efficacy of PAC-14028 in Children With Mild to Moderate Pediatric Atopic Dermatitis
- ClinicalTrials.gov ID
- NCT02748993
- Acronym / sponsor ID
- AP-TRPV1_PII-05
- Conditions
- Atopic Dermatitis
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Amorepacific CorporationIndustry (pharma, biotech, devices)
- Study start
- Mar 2016
- Primary completion
- Sep 2018 (actual)
- Study completion
- Oct 2018 (actual)
- First posted
- 22 Apr 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 1 and 2 study to assess the safety and efficacy of PAC-14028 cream in children with atopic dermatitis.
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 4 weeks |
| PAC-14028 Cream 0.3% | Experimental | Drug: PAC-14028 Cream 0.3%PAC-14028 Cream 0.3%, Twice daily for 4 weeks |
| PAC-14028 Cream 1.0% | Experimental | Drug: PAC-14028 Cream 1.0%PAC-14028 Cream 1.0%, Twice daily for 4 weeks |
| PAC-14028 Cream Vehicle | Placebo comparator | Drug: PAC-14028 Cream VehiclePAC-14028 Cream Vehicle, twice daily for 4 weeks |
Who may qualify
- Ages
- 24 months to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Male and female patients aged 24 months - 12 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 has applied stable amount of emollients daily before baseline visit
- 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, psychial 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: 4 weeks
% of patients with IGA score of 0 (clear) or 1 (almost clear)
Blood concentrations of PAC-14028
Time frame: Day 1, Day 28
Blood concentrations of PAC-14028
4 secondary outcomes
Change of IGA (Investigator's Global Assessment)
Time frame: 1, 2, 4 week(s)
Change of SCORAD (Severity Scoring of Atopic Dermatitis)
Time frame: 1, 2, 4 week(s)
% Change of EASI (Eczema Area and Severity Index)
Time frame: 1, 2, 4 week(s)
Patient satisfaction measurement
Time frame: 4 weeks
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 Nov 2018.
- 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.
Kyuhan Kim, MD, PhD principal investigator
Seoul National University Hospital
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 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 3 sites 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 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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: 4 weeks). The study lists 2 primary outcomes in all. 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 Nov 2018.