Skin PruritusPhase 2NCT02052531
Evaluation of the Antipruritic Effect of PAC-14028 Cream in Skin Pruritus
A Phase 2 study testing PAC-14028 in people with Skin Pruritus, run by Amorepacific Corporation at 1 site in South Korea.
Trial summary
The objective of this study was to find a clinically appropriate dose of PAC-14028 cream by comparatively evaluating the efficacy and safety of PAC-14028 cream of Amorepacific Corporation in patients with dermal pruritus. Read more about this study
- Who is it for?
- Ages 20 to 65 years
- Conditions the study is for
- Skin Pruritus
- What is being tested?
- PAC-14028
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 74 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jan 2013to Jul 2013
- 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 and female patients at the age of 20 to 65 years old (both inclusive)
- Pruritus test ≥ 5cm (10cm Visual Analogue Scale [VAS]) at baseline
- Eczema or dry skin on the study drug application site
- Women of childbearing potential should have a negative urine pregnancy test at screening and agree to employ an effective method of birth control (surgical sterilization or oral contraceptives, barrier method with spermicides, intrauterine device, etc.) during the study period.
- Voluntarily signed written informed consent forms for study participation.
Who cannot join
- Pruritus due to other medical (liver disease, renal failure, etc.), psychotic, or neuropathic causes rather than as a skin disease.
- Chronic skin diseases such as malignant tumor or chronic urticaria, among skin diseases.
- Simple pruritus caused by allergic substances such as scabies or insect bites.
- Presence of symptoms of generalized infection at the time of study participation.
- Previous local treatment or antibiotics administration for pruritus within 7 days prior to study participation.
- Previous use of oral steroids within 1 month and local steroids within 2 weeks prior to study participation.
Show all 13Show fewer
- History of physical treatment for pruritus, including phototherapy, within 1 month prior to study participation.
- Patients who are treated with prohibited concomitant drugs or considered to inevitably require treatment with prohibited concomitant drugs during the study period.
- Renal function impairment with creatinine level
- Hepatic function impairment with aspartate aminotransferase (AST)/ alanine aminotransferase (ALT)
- Pregnant and lactating women
- Participation in another clinical study within 1 month prior to screening.
- Patients considered ineligible for study participation by the principal investigator or sub-investigator for other reasons; pruritus due to other medical (liver disease, renal failure, etc.), psychotic, or neuropathic causes rather than as a skin disease.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase II, Single Center, Double-blind, Randomized Clinical Trial to Evaluate the Efficacy and Safety of PAC-14028 Cream in Dermal Pruritus
The objective of this study was to find a clinically appropriate dose of PAC-14028 cream by comparatively evaluating the efficacy and safety of PAC-14028 cream of Amorepacific Corporation in patients with dermal pruritus.
- Conditions
- Skin Pruritus
- Being tested
- PAC-14028, Vehicle
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PAC-14028Drug
Also called PAC-14028 Cream 0.3%, PAC-14028 Cream 1.0%
Participants received topical PAC-14028 cream 0.3 or 1% twice daily for 4 weeks
VehicleOther
Also called Vehicle of PAC-14028 Cream
Participants received topical Vehicle twice daily for 4 weeks
| Study group | Role | What they receive |
|---|---|---|
| PAC-14028 cream 0.3% | Experimental | PAC-14028 cream 0.3%, twice daily for 28 days Receives: Drug: PAC-14028 |
| PAC-14028 cream 1.0% | Experimental | PAC-14028 cream 1.0%, twice daily for 28days Receives: Drug: PAC-14028 |
| Vehicle | Placebo comparator | Vehicle, twice daily for 28days Receives: Other: Vehicle |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Visual Analog Scale (VAS)
Patient reported outcome of pruritis measurement on a change in visual analog scale
Measured: Baseline through Study Day 28
Secondary outcomes (4)
Treatment success rate
Measured: Baseline through Study Day 28
Change in specified symptom sum score (SRRC) Index
Measured: Baseline through Study Day 28
Change in transepidermal water loss
Measured: Baseline through Study Day 28
Change in skin hydration
Measured: Baseline through Study Day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2014 (estimated)
- Study startJan 2013
- Primary completionJun 2013
- Study completionJul 2013
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
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amorepacific Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kyu-Han Kim, MD,Ph.D, Principal investigator, Department of Dermatology, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02052531
- Sponsor's protocol ID
- AP-TRPV1_PII-01
- Status last verified
- Sep 2015
- First submitted
- 31 Jan 2014
- Last updated
- 14 Sep 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II, Single Center, Double-blind, Randomized Clinical Trial to Evaluate the Efficacy and Safety of PAC-14028 Cream in Dermal Pruritus
- ClinicalTrials.gov ID
- NCT02052531
- Acronym / sponsor ID
- AP-TRPV1_PII-01
- Conditions
- Skin Pruritus
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- Amorepacific CorporationIndustry (pharma, biotech, devices)
- Study start
- Jan 2013
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 3 Feb 2014 (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 objective of this study was to find a clinically appropriate dose of PAC-14028 cream by comparatively evaluating the efficacy and safety of PAC-14028 cream of Amorepacific Corporation in patients with dermal pruritus.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| PAC-14028 cream 0.3% | Experimental | Drug: PAC-14028PAC-14028 cream 0.3%, twice daily for 28 days |
| PAC-14028 cream 1.0% | Experimental | Drug: PAC-14028PAC-14028 cream 1.0%, twice daily for 28days |
| Vehicle | Placebo comparator | Other: VehicleVehicle, twice daily for 28days |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male and female patients at the age of 20 to 65 years old (both inclusive)
- Pruritus test ≥ 5cm (10cm Visual Analogue Scale [VAS]) at baseline
- Eczema or dry skin on the study drug application site
- Women of childbearing potential should have a negative urine pregnancy test at screening and agree to employ an effective method of birth control (surgical sterilization or oral contraceptives, barrier method with spermicides, intrauterine device, etc.) during the study period.
- Voluntarily signed written informed consent forms for study participation.
Key exclusion criteria (13 listed)
- Pruritus due to other medical (liver disease, renal failure, etc.), psychotic, or neuropathic causes rather than as a skin disease.
- Chronic skin diseases such as malignant tumor or chronic urticaria, among skin diseases.
- Simple pruritus caused by allergic substances such as scabies or insect bites.
- Presence of symptoms of generalized infection at the time of study participation.
- Previous local treatment or antibiotics administration for pruritus within 7 days prior to study participation.
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-14028Also: PAC-14028 Cream 0.3%, PAC-14028 Cream 1.0%Participants received topical PAC-14028 cream 0.3 or 1% twice daily for 4 weeks | Drug | PAC-14028 cream 0.3%, PAC-14028 cream 1.0% |
| VehicleAlso: Vehicle of PAC-14028 CreamParticipants received topical Vehicle twice daily for 4 weeks | Other | Vehicle |
Primary outcome
Change in Visual Analog Scale (VAS)
Time frame: Baseline through Study Day 28
Patient reported outcome of pruritis measurement on a change in visual analog scale
4 secondary outcomes
Treatment success rate
Time frame: Baseline through Study Day 28
Change in specified symptom sum score (SRRC) Index
Time frame: Baseline through Study Day 28
Change in transepidermal water loss
Time frame: Baseline through Study Day 28
Change in skin hydration
Time frame: Baseline through Study Day 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 14 Sep 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.
Kyu-Han Kim, MD,Ph.D principal investigator
Department of Dermatology, Seoul National 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 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 5 inclusion and 13 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 14 Sep 2015. 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 Visual Analog Scale (VAS) (time frame: Baseline through Study 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 14 Sep 2015.