Skin PruritusPhase 2NCT02565134
A Study to Evaluate the Safety and Efficacy of PAC-14028 Cream in Skin Pruritus
A Phase 2 study testing PAC-14028 cream 0.1%, PAC-14028 cream 0.3% and PAC-14028 cream 1.0% in people with Skin Pruritus, run by Amorepacific Corporation at 1 site in South Korea.
Trial summary
The study is a Phase II, multi center, randomized, double-blind, placebo-controlled study in male and female subjects, aged ≥ 19 years with skin pruritus. 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 70 years
- Conditions the study is for
- Skin Pruritus
- 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
- 296 participants
- Where
- 1 siteSouth Korea
- Study dates
- Oct 2014to Jul 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
- Patients who have eczema or xerosis cutis at the area where investigational product is applied (arm or leg)
- Patients whose result of the pruritus test (Visual Analogue Scale, VAS) at Visit 1 and 2 is 5 or more
- Patients whose overall dry skin score of the area where investigational product is applied at Visit 1 and 2 is 2 points or more
Who cannot join
- Patients with pruritus caused by other medical, psychotic and nervous causes other than the skin disease
- Patients with such skin diseases as malignant tumor or chronic urticaria among patients with skin diseases
- Patients with simple pruritus caused by such allergic material as scabies, and insect bite wound
- Patients with the symptom of systemic infection at the time of the participation in the clinical study
- Patients with a history of taking topical treatment drug, topical steroid agent or antibiotics for the treatment of pruritus within 2 weeks
- Patients with a history of taking oral steroid agent within 4 weeks
Show all 9Show fewer
- Patients with a history of taking a physical treatment for the treatment of pruritus including phototherapy within 4 weeks
- Pregnant or breast-feeding women
- Women at a childbearing age who has childbearing potential or has a plan to get pregnant during the clinical study period
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Multi Center, Double-blind, Randomized, Placebo-controlled Parallel-group, Dose Finding Phase II Clinical Trial to Evaluate Antipruritic Effect and Safety of PAC-14028 Cream (0.1%, 0.3%, 1.0%) in Skin Pruritus Patients
The study is a Phase II, multi center, randomized, double-blind, placebo-controlled study in male and female subjects, aged ≥ 19 years with skin pruritus. All subjects will receive BID topical applications of PAC-14028 cream or vehicle for up to 4 weeks.
- Conditions
- Skin Pruritus
- Being tested
- PAC-14028 cream 0.1%, PAC-14028 cream 0.3%, PAC-14028 cream 1.0%, PAC-14028 cream vehicle
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.
Change in intensity of pruritus as measured by 10 cm VAS
Measured: Week 4 from baseline
Secondary outcomes (3)
Treatment success rate (A decrease in VAS by 2 or more is judged as a success)
Measured: Week 4 from baseline
Change in Overall Dry Skin (ODS) score
Measured: Week 4 from baseline
Change in Transepidermal Water Loss (TEWL)
Measured: Week 4 from baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2015 (estimated)
- Study startOct 2014
- Primary completionJun 2016
- Study completionJul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Skin PruritusStudies 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
- 296 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amorepacific Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Miyoung Park, PhD, Study director, Amorepacific R&D Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02565134
- Sponsor's protocol ID
- AP-TRPV1_PII-02
- Status last verified
- Jul 2016
- First submitted
- 30 Sep 2015
- Last updated
- 15 Jul 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi Center, Double-blind, Randomized, Placebo-controlled Parallel-group, Dose Finding Phase II Clinical Trial to Evaluate Antipruritic Effect and Safety of PAC-14028 Cream (0.1%, 0.3%, 1.0%) in Skin Pruritus Patients
- ClinicalTrials.gov ID
- NCT02565134
- Acronym / sponsor ID
- AP-TRPV1_PII-02
- Conditions
- Skin Pruritus
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 296 participants (actual)
- Lead sponsor
- Amorepacific CorporationIndustry (pharma, biotech, devices)
- Study start
- Oct 2014
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 1 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, multi center, randomized, double-blind, placebo-controlled study in male and female subjects, aged ≥ 19 years with skin pruritus. 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
- 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
- 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
- Patients who have eczema or xerosis cutis at the area where investigational product is applied (arm or leg)
- Patients whose result of the pruritus test (Visual Analogue Scale, VAS) at Visit 1 and 2 is 5 or more
- Patients whose overall dry skin score of the area where investigational product is applied at Visit 1 and 2 is 2 points or more
Key exclusion criteria (9 listed)
- Patients with pruritus caused by other medical, psychotic and nervous causes other than the skin disease
- Patients with such skin diseases as malignant tumor or chronic urticaria among patients with skin diseases
- Patients with simple pruritus caused by such allergic material as scabies, and insect bite wound
- Patients with the symptom of systemic infection at the time of the participation in the clinical study
- Patients with a history of taking topical treatment drug, topical steroid agent or antibiotics for the treatment of pruritus within 2 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 0.1%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
Change in intensity of pruritus as measured by 10 cm VAS
Time frame: Week 4 from baseline
3 secondary outcomes
Treatment success rate (A decrease in VAS by 2 or more is judged as a success)
Time frame: Week 4 from baseline
Change in Overall Dry Skin (ODS) score
Time frame: Week 4 from baseline
Change in Transepidermal Water Loss (TEWL)
Time frame: Week 4 from baseline
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 15 Jul 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.
Miyoung Park, PhD study director
Amorepacific R&D Center
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 Skin Pruritus, 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 9 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 15 Jul 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?
Change in intensity of pruritus as measured by 10 cm VAS (time frame: Week 4 from baseline). 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 15 Jul 2016.