Atopic DermatitisPhase 2NCT02583022
A Study to Evaluate the Safety and Efficacy of PAC-14028 Cream in Atopic Dermatitis
A Phase 2 study testing PAC-14028 cream 1.0% and Elidel cream 1% in people with Atopic Dermatitis, run by Amorepacific Corporation.
Trial summary
The study is a Phase II, single center, randomized, open-label, placebo-controlled study in male and female subjects, aged ≥ 20 years with mild to moderate atopic dermatitis. All subjects will receive BID topical applications of PAC-14028 cream or vehicle or Elidel cream for up to 4 weeks. Read more about this study
- Who is it for?
- Ages 20 to 65 years
- Conditions the study is for
- Atopic Dermatitis
- What is being tested?
- PAC-14028 cream 1.0% and Elidel cream 1%
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 74 participants
- Where
- No sites listed yet
- Study dates
- Jun 2013to Aug 2015
- 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 20 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female patients aged between 20 and 65 years old
- Patients with atopic dermatitis, diagnosed according to Hanifin and Rajka diagnostic criteria
- SCORAD (SCORing Atopic Dermatitis) Score less than 40
Who cannot join
- Patients presenting symptoms of systemic infection at screening
- Patients who had been treated with oral steroids, oral antibiotics, systemic phototherapy, or immunosuppressants within the last 1 month prior to the investigational product administration
- Patients who had been treated with topical steroids or antibiotics within the last 2 weeks prior to the investigational product administration
- Pregnant women or breastfeeding women
- Women of childbearing potential or women who are planning a pregnancy during the study
About this study
Official title: A Randomized, Open-label, Single Center, Investigator-initiated Clinical Study to Evaluate the Safety and Efficacy of PAC-14028 Cream in Subjects With Mild to Moderate Atopic Dermatitis
The study is a Phase II, single center, randomized, open-label, placebo-controlled study in male and female subjects, aged ≥ 20 years with mild to moderate atopic dermatitis. All subjects will receive BID topical applications of PAC-14028 cream or vehicle or Elidel cream for up to 4 weeks.
- Conditions
- Atopic Dermatitis
- Being tested
- PAC-14028 cream 1.0%, PAC-14028 cream vehicle, Elidel cream 1%
- 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 1.0%Drug
Topical application
PAC-14028 cream vehicleDrug
Topical application
Elidel cream 1%Drug
Topical application
| Study group | Role | What they receive |
|---|---|---|
| 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 |
| Elidel cream 1% | Active comparator | Elidel cream 1%, Twice daily for 4 weeks Receives: Drug: Elidel cream 1% |
What is being measured
The primary outcome is the main question the study is designed to answer.
SCORing Atopic Dermatitis (SCORAD) index
Measured: Change from baseline at Day 28
Secondary outcomes (6)
Visual Analogue Scale (VAS) score
Measured: Change from baseline at Day 7, 14 and 28
Success rate to pruritus treatment
Measured: Change from baseline at Day 7, 14 and 28
Eczema Area and Severity Index (EASI) score
Measured: Change from baseline at Day 7, 14 and 28
Each SCORAD index
Measured: Change from baseline at Day 7, 14 and 28
Transepidermal Water Loss (TEWL) level
Measured: Change from baseline at Day 7, 14 and 28
Skin Hydration level
Skin hydration was measured using the Corneometer
Measured: Change from baseline at Day 7, 14 and 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2015 (estimated)
- Study startJun 2013
- Primary completionJan 2014
- Study completionAug 2015
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
- None (open label)
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amorepacific Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- BeomJoon Kim, Professor, Principal investigator, Department of Dermatology, Chungang University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02583022
- Sponsor's protocol ID
- TRPV1-AD_IIT
- Status last verified
- Oct 2015
- First submitted
- 30 Sep 2015
- Last updated
- 21 Oct 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-label, Single Center, Investigator-initiated Clinical Study to Evaluate the Safety and Efficacy of PAC-14028 Cream in Subjects With Mild to Moderate Atopic Dermatitis
- ClinicalTrials.gov ID
- NCT02583022
- Acronym / sponsor ID
- TRPV1-AD_IIT
- Conditions
- Atopic Dermatitis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- Amorepacific CorporationIndustry (pharma, biotech, devices)
- Study start
- Jun 2013
- Primary completion
- Jan 2014 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 21 Oct 2015 (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 study is a Phase II, single center, randomized, open-label, placebo-controlled study in male and female subjects, aged ≥ 20 years with mild to moderate atopic dermatitis. All subjects will receive BID topical applications of PAC-14028 cream or vehicle or Elidel cream for up to 4 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 |
| Elidel cream 1% | Active comparator | Drug: Elidel cream 1%Elidel cream 1%, Twice daily for 4 weeks |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Male or female patients aged between 20 and 65 years old
- Patients with atopic dermatitis, diagnosed according to Hanifin and Rajka diagnostic criteria
- SCORAD (SCORing Atopic Dermatitis) Score less than 40
Key exclusion criteria (5 listed)
- Patients presenting symptoms of systemic infection at screening
- Patients who had been treated with oral steroids, oral antibiotics, systemic phototherapy, or immunosuppressants within the last 1 month prior to the investigational product administration
- Patients who had been treated with topical steroids or antibiotics within the last 2 weeks prior to the investigational product administration
- Pregnant women or breastfeeding women
- Women of childbearing potential or women who are planning a pregnancy 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 1.0%Topical application | Drug | PAC-14028 cream 1.0% |
| PAC-14028 cream vehicleTopical application | Drug | PAC-14028 cream vehicle |
| Elidel cream 1%Topical application | Drug | Elidel cream 1% |
Primary outcome
SCORing Atopic Dermatitis (SCORAD) index
Time frame: Change from baseline at Day 28
6 secondary outcomes
Visual Analogue Scale (VAS) score
Time frame: Change from baseline at Day 7, 14 and 28
Success rate to pruritus treatment
Time frame: Change from baseline at Day 7, 14 and 28
Eczema Area and Severity Index (EASI) score
Time frame: Change from baseline at Day 7, 14 and 28
Each SCORAD index
Time frame: Change from baseline at Day 7, 14 and 28
Transepidermal Water Loss (TEWL) level
Time frame: Change from baseline at Day 7, 14 and 28
Skin Hydration level
Time frame: Change from baseline at Day 7, 14 and 28
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 21 Oct 2015.
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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, Professor principal investigator
Department of Dermatology, Chungang University Hospital
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing PAC-14028 cream 1.0% and Elidel cream 1% in people with Atopic Dermatitis, run by Amorepacific Corporation.
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 3 inclusion and 5 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 21 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
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?
SCORing Atopic Dermatitis (SCORAD) index (time frame: Change from baseline at Day 28). 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 21 Oct 2015.