Seborrheic DermatitisPhase 2NCT02749383
A Study to Evaluate the Safety and Efficacy of PAC-14028 Cream in Seborrheic Dermatitis
A Phase 2 study testing PAC-14028 cream 0.3% and PAC-14028 cream 1.0% in people with Seborrheic Dermatitis, run by Amorepacific Corporation.
Trial summary
This study is a Phase II, single center, randomized, double-blind, placebo-controlled study in male and female subjects, aged ≥ 19 years with mild to moderate seborrheic dermatitis of the face. All subjects will receive BID topical applications of PAC-14028 cream or vehicle for up to 4 weeks. Read more about this study
- Who is it for?
- Ages 19 to 65 years
- Conditions the study is for
- Seborrheic Dermatitis
- What is being tested?
- 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
- 75 participants
- Where
- No sites listed yet
- Study dates
- Feb 2014to Oct 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 19 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female patients aged between 19 and 65 years old
- Clinical diagnosis of seborrheic dermatitis in the facial area with Erythema severity ≥ 2 and Scaling severity ≥ 2
- IGE (Investigator's Global Evaluation) Score 2 or 3
Who cannot join
- Patients with psoriasis, atopic dermatitis, facial acne, rosacea or perioral dermatitis
- Patients who have been infected with bacteria, fungi, virus and animal infectious disease on the facial area
- Patients who were administered topical antifungal agents, steroids, retinoids, or calcineurin suppressants for the treatment of seborrheic dermatitis within the last 2 weeks
- Patients who were administered systemic antifungal agents, steroids, retinoids, or immunosuppressants for the treatment of seborrheic dermatitis within the last 4 weeks
- Patients who were administered local antibiotics for the treatment of seborrheic dermatitis within the last 4 weeks
- Pregnant women, breastfeeding women or women of childbearing potential or women who are planning a pregnancy during the study
About this study
Official title: A Randomized, Double-blind, Single Center, Investigator-initiated Clinical Study to Evaluate the Safety and Efficacy of PAC-14028 Cream in Subjects With Mild to Moderate Seborrheic Dermatitis of the Face
This study is a Phase II, single center, randomized, double-blind, placebo-controlled study in male and female subjects, aged ≥ 19 years with mild to moderate seborrheic dermatitis of the face. All subjects will receive BID topical applications of PAC-14028 cream or vehicle for up to 4 weeks.
- Conditions
- Seborrheic Dermatitis
- Being tested
- PAC-14028 cream 0.3%, PAC-14028 cream 1.0%, PAC-14028 cream vehicle
- Medical subject headings
- Dermatitis, Seborrheic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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 0.3% | Experimental | Twice daily for 4 weeks Receives: Drug: PAC-14028 cream 0.3% |
| PAC-14028 cream 1.0% | Experimental | Twice daily for 4 weeks Receives: Drug: PAC-14028 cream 1.0% |
| PAC-14028 cream vehicle | Placebo comparator | 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.
Treatment success rate in IGE(Investigator's Global Evaluation)
Treatment success rate in IGE on 28th day from the baseline
Measured: Change from Baseline at Day 14 and Day 28
Secondary outcomes (3)
Change in Erythema severity score
Measured: Change from baseline at Day 14 and 28
Change in Scale severity score
Change from baseline at Day 14 and 28
Measured: Baseline, Day 14 and Day 28
Change in Visual Analogue Scale(VAS) score
Measured: Change from baseline at Day 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 posted25 Apr 2016 (estimated)
- Study startFeb 2014
- Primary completionDec 2014
- Study completionOct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Seborrheic 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
- 75 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
- NCT02749383
- Sponsor's protocol ID
- TRPV1-SD_IIT
- Status last verified
- Apr 2016
- First submitted
- 30 Sep 2015
- Last updated
- 25 Apr 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Single Center, Investigator-initiated Clinical Study to Evaluate the Safety and Efficacy of PAC-14028 Cream in Subjects With Mild to Moderate Seborrheic Dermatitis of the Face
- ClinicalTrials.gov ID
- NCT02749383
- Acronym / sponsor ID
- TRPV1-SD_IIT
- Conditions
- Seborrheic Dermatitis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Amorepacific CorporationIndustry (pharma, biotech, devices)
- Study start
- Feb 2014
- Primary completion
- Dec 2014 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 25 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 study is a Phase II, single center, randomized, double-blind, placebo-controlled study in male and female subjects, aged ≥ 19 years with mild to moderate seborrheic dermatitis of the face. All subjects will receive BID topical applications of PAC-14028 cream or vehicle for up to 4 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| PAC-14028 cream 0.3% | Experimental | Drug: PAC-14028 cream 0.3%Twice daily for 4 weeks |
| PAC-14028 cream 1.0% | Experimental | Drug: PAC-14028 cream 1.0%Twice daily for 4 weeks |
| PAC-14028 cream vehicle | Placebo comparator | Drug: PAC-14028 cream vehicleTwice daily for 4 weeks |
Who may qualify
- Ages
- 19 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 19 and 65 years old
- Clinical diagnosis of seborrheic dermatitis in the facial area with Erythema severity ≥ 2 and Scaling severity ≥ 2
- IGE (Investigator's Global Evaluation) Score 2 or 3
Key exclusion criteria (6 listed)
- Patients with psoriasis, atopic dermatitis, facial acne, rosacea or perioral dermatitis
- Patients who have been infected with bacteria, fungi, virus and animal infectious disease on the facial area
- Patients who were administered topical antifungal agents, steroids, retinoids, or calcineurin suppressants for the treatment of seborrheic dermatitis within the last 2 weeks
- Patients who were administered systemic antifungal agents, steroids, retinoids, or immunosuppressants for the treatment of seborrheic dermatitis within the last 4 weeks
- Patients who were administered local antibiotics for the treatment of seborrheic dermatitis within the last 4 weeks
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 0.3%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
Treatment success rate in IGE(Investigator's Global Evaluation)
Time frame: Change from Baseline at Day 14 and Day 28
Treatment success rate in IGE on 28th day from the baseline
3 secondary outcomes
Change in Erythema severity score
Time frame: Change from baseline at Day 14 and 28
Change in Scale severity score
Time frame: Baseline, Day 14 and Day 28
Change in Visual Analogue Scale(VAS) score
Time frame: Change from baseline at Day 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 25 Apr 2016.
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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 0.3% and PAC-14028 cream 1.0% in people with Seborrheic 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 6 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 25 Apr 2016. 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?
Treatment success rate in IGE(Investigator's Global Evaluation) (time frame: Change from Baseline at Day 14 and 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 25 Apr 2016.