HealthyPhase 1NCT01638117
Cumulative Irritation Test of PAC-14028 in Healthy Volunteers
A Phase 1 study testing PAC14028-0.1, PAC14028-0.3 and PAC14028-1.0 in people with Healthy, run by Amorepacific Corporation at 1 site in South Korea.
Trial summary
The purpose of this study is to determine the cumulative irritation potential of the products listed by the Sponsor. Read more about this study
- Who is it for?
- Ages 20 to 59 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- PAC14028-0.1, PAC14028-0.3 and PAC14028-1.0
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 35 participants
- Where
- 1 siteSouth Korea
- Study dates
- Apr 2012to Aug 2012
- Phase
- Phase 1
- 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 59 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy volunteers of either sex, at least 20 years to 59 Years.
- Females must be of non-childbearing potential (i.e., post-menopausal or surgically sterile). All females must submit to a urine pregnancy test and have a negative result at Day 1 and at the final study visit.
- Subjects may be of any skin type or race providing their degree of skin pigmentation does not interfere with readings of skin reactions.
- Who voluntarily decides study participation after receiving detailed explanation about the study and fully understanding it and who provides written consent for compliance with study requirement including proper contraception.
Who cannot join
- Atopic dermatitis/eczema, psoriasis will be excluded. Any skin disease that would in any way confound interpretation of the study results.
- Asthma and chronic bronchitis will be excluded.
- Inability to evaluate the skin in and around the potential patch test sites on the arm due to erythema, eschar, excoriation, tattoos, scars, unevenness in skin tones, or other skin damage or abnormality.
- A history of sensitivity to any component of any of the formulations and the Finn chamber.
- Used systemic or topical corticosteroids or other immunosuppressive medications within 1 weeks of the Day 1 visit.
- Used nonsteroidal anti-inflammatory medications within 2 weeks of the Day 1 visit.
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- Received immunizations within 2 weeks of the Day 1 visit.
- Any major illness within 4 weeks of the Day 1 visit.
- Female who is pregnant, trying to become pregnant, or breast feeding
- Use of chronic medications (such as antihistamines, corticosteroids, analgesics and anti-inflammatories) for one week before and during the study.
- Currently using any medication that, in the opinion of the investigator, may affect the evaluation of the study product or place the subject at undue risk.
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Seoul National University Hospital, Department of Dermatology
Seoul, Seoul, 110-744
About this study
Official title: Phase I Clinical Trial to Investigate the Cumulative Skin Irritation of PAC-14028 in Healthy Volunteers
The purpose of this study is to determine the cumulative irritation potential of the products listed by the Sponsor.
Read the detailed description
Healthy, adult volunteers of either sex will be patched daily on his/her arm with multiple strengths of PAC-14028 cream, non-active comparator and an active comparator over the course of 21 consecutive days. Twenty-four hours after each application, the Finn-chamber patches will be removed and the site evaluated using a five-point scale for irritation.
- Conditions
- Healthy
- Being tested
- PAC14028-Vehicle, PAC14028-0.1, PAC14028-0.3, PAC14028-1.0, Saline
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PAC14028-VehicleOther
Also called PAC-14208 cream vehicle
PAC-14028 Cream Vehicle, Daily for up to 21 days
PAC14028-0.1Drug
Also called PAC-14208 Cream 0.1%
PAC-14028 Cream, 0.1%, Daily for up to 21 days
PAC14028-0.3Drug
Also called PAC-14208 Cream 0.3%
PAC-14028 Cream, 0.3%, Daily for up to 21 days
PAC14028-1.0Drug
Also called PAC-14028 Cream 1.0%
PAC-14028 Cream, 1%, Daily for up to 21 days
SalineOther
Also called 0.9% Sodium chloride
Saline, Daily for up to 21 days
PositiveOther
Sodium Lauryl Sulfate, 0.5%, Daily for up to 21 days
| Study group | Role | What they receive |
|---|---|---|
| PAC14028-Vehicle | Placebo comparator | PAC-14028 Cream Vehicle Receives: Other: PAC14028-Vehicle |
| PAC14028-0.1 | Experimental | PAC-14028 Cream 0.1% Receives: Drug: PAC14028-0.1 |
| PAC14028-0.3 | Experimental | PAC-14028 Cream 0.3% Receives: Drug: PAC14028-0.3 |
| PAC14028-1.0 | Experimental | PAC-14028 Cream 1% Receives: Drug: PAC14028-1.0 |
| Placebo | Placebo comparator | Saline Receives: Other: Saline |
| Positive control | Active comparator | Sodium Lauryl Sulfate, 0.5% Receives: Other: Positive |
What is being measured
The primary outcome is the main question the study is designed to answer.
Irritation Score (5-point scale, 0-4)
Measured: Daily for 21 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2012 (estimated)
- Study startApr 2012
- Primary completionAug 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amorepacific Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kyu-Han Kim, M.D.,Ph.D., Study director, Seoul National University Hospital, Department of Dermatology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01638117
- Sponsor's protocol ID
- AP-TRPV1_PI-02
- Status last verified
- Jan 2014
- First submitted
- 9 Jul 2012
- Last updated
- 22 Jan 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Clinical Trial to Investigate the Cumulative Skin Irritation of PAC-14028 in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT01638117
- Acronym / sponsor ID
- AP-TRPV1_PI-02
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Amorepacific CorporationIndustry (pharma, biotech, devices)
- Study start
- Apr 2012
- Primary completion
- Aug 2012 (actual)
- First posted
- 11 Jul 2012 (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 purpose of this study is to determine the cumulative irritation potential of the products listed by the Sponsor.
Detailed description
Healthy, adult volunteers of either sex will be patched daily on his/her arm with multiple strengths of PAC-14028 cream, non-active comparator and an active comparator over the course of 21 consecutive days. Twenty-four hours after each application, the Finn-chamber patches will be removed and the site evaluated using a five-point scale for irritation.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| PAC14028-Vehicle | Placebo comparator | Other: PAC14028-VehiclePAC-14028 Cream Vehicle |
| PAC14028-0.1 | Experimental | Drug: PAC14028-0.1PAC-14028 Cream 0.1% |
| PAC14028-0.3 | Experimental | Drug: PAC14028-0.3PAC-14028 Cream 0.3% |
| PAC14028-1.0 | Experimental | Drug: PAC14028-1.0PAC-14028 Cream 1% |
| Placebo | Placebo comparator | Other: SalineSaline |
| Positive control | Active comparator | Other: PositiveSodium Lauryl Sulfate, 0.5% |
Who may qualify
- Ages
- 20 to 59 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy volunteers of either sex, at least 20 years to 59 Years.
- Females must be of non-childbearing potential (i.e., post-menopausal or surgically sterile). All females must submit to a urine pregnancy test and have a negative result at Day 1 and at the final study visit.
- Subjects may be of any skin type or race providing their degree of skin pigmentation does not interfere with readings of skin reactions.
- Who voluntarily decides study participation after receiving detailed explanation about the study and fully understanding it and who provides written consent for compliance with study requirement including proper contraception.
Key exclusion criteria (11 listed)
- Atopic dermatitis/eczema, psoriasis will be excluded. Any skin disease that would in any way confound interpretation of the study results.
- Asthma and chronic bronchitis will be excluded.
- Inability to evaluate the skin in and around the potential patch test sites on the arm due to erythema, eschar, excoriation, tattoos, scars, unevenness in skin tones, or other skin damage or abnormality.
- A history of sensitivity to any component of any of the formulations and the Finn chamber.
- Used systemic or topical corticosteroids or other immunosuppressive medications within 1 weeks of the Day 1 visit.
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 |
|---|---|---|
| PAC14028-VehicleAlso: PAC-14208 cream vehiclePAC-14028 Cream Vehicle, Daily for up to 21 days | Other | PAC14028-Vehicle |
| PAC14028-0.1Also: PAC-14208 Cream 0.1%PAC-14028 Cream, 0.1%, Daily for up to 21 days | Drug | PAC14028-0.1 |
| PAC14028-0.3Also: PAC-14208 Cream 0.3%PAC-14028 Cream, 0.3%, Daily for up to 21 days | Drug | PAC14028-0.3 |
| PAC14028-1.0Also: PAC-14028 Cream 1.0%PAC-14028 Cream, 1%, Daily for up to 21 days | Drug | PAC14028-1.0 |
| SalineAlso: 0.9% Sodium chlorideSaline, Daily for up to 21 days | Other | Placebo |
| PositiveSodium Lauryl Sulfate, 0.5%, Daily for up to 21 days | Other | Positive control |
Primary outcome
Irritation Score (5-point scale, 0-4)
Time frame: Daily for 21 days
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 22 Jan 2014.
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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, M.D.,Ph.D. study director
Seoul National University Hospital, Department of Dermatology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing PAC14028-0.1, PAC14028-0.3 and PAC14028-1.0 in people with Healthy, 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 11 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 22 Jan 2014. 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 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.
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?
Irritation Score (5-point scale, 0-4) (time frame: Daily for 21 days). 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 22 Jan 2014.