Erythematotelangiectatic RosaceaPhase 2NCT02052999
Study to Evaluate the Efficacy and Safety of PAC-14028 Cream in Rosacea Patients
A Phase 2 study testing PAC-14028 cream 1% and Rozex gel 0.75% in people with Erythematotelangiectatic Rosacea and Papulopustular Rosacea, run by Amorepacific Corporation at 1 site in South Korea.
Trial summary
The objective of this study is to determine the efficacy and safety of PAC-14028 1% cream of Amorepacific Corporation in patients with erythema-telangiectatic or papulopustular rosacea Read more about this study
- Who is it for?
- Ages 20 to 65 years
- Conditions the study is for
- Erythematotelangiectatic Rosacea, Papulopustular Rosacea
- What is being tested?
- PAC-14028 cream 1% and Rozex gel 0.75%
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteSouth Korea
- Study dates
- Feb 2013to Aug 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
- Clinical diagnosis of erythematotelangiectatic or papulopustular rosacea according to National Rosacea Committee Expert Society with
- Erythema severity ≥ 1
- Telangiectasia severity ≥ 1
- At least 3 papules or pustules in facial region
- IGA score ≥ 2
- Voluntarily signed written informed consent forms for study participation
Who cannot join
- Patients who are unable to be diagnosed or evaluated for rosacea due to tattoo or scar in the facial area
- Patients who are unable to be diagnosed or evaluated for rosacea due to excess hair(e.g., mustache, beard, whiskers etc.) in the facial area
- Patients who are sensitive to the drug or vehicle
- Previous administration of oral retinoid or vitamin A(≥10,000 units/day) within 6 months prior to visit 1
- Previous use of estrogen or oral contraceptives within 3 months prior to visit 1
- Previous use of topical retinoids or oral antibiotics (e.g., tetracycline, tetracycline derivatives, erythromycin, erythromycin derivatives, sulfamethoxazole, trimethoprim) or oral steroid for the treatment of facial rosacea within 1 month prior to visit 1
Show all 18Show fewer
- Previous use of topical steroid or topical antibiotics, topical treatment for rosacea(e.g., metronidazole, azelaic acid) within 2 weeks prior to visit 1
- Presently undergoing anti-coagulant therapies
- History of hematologic disease
- Ocular-only, Phymatous rosacea, or papulopustular rosacea patients who require systemic antibiotics
- History of laser treatment for rosacea within 6 weeks prior to visit 1
- Alcoholic or drug abuse patients
- 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 higher than twice of maximum normal range
- Hepatic function impairment with AST/ALT higher than twice of maximum normal range
- Pregnant and lactating woman, woman with child-birth potential(should have negative pregnancy test at the baseline visit of the study)
- 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; rosacea 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: An Open Label Pilot Study to Evaluate the Efficacy of PAC-14028 in the Treatment of Erythematotelangiectatic Rosacea and Papulopustular Rosacea
The objective of this study is to determine the efficacy and safety of PAC-14028 1% cream of Amorepacific Corporation in patients with erythema-telangiectatic or papulopustular rosacea
- Being tested
- PAC-14028 cream 1%, Vehicle, Rozex gel 0.75%
- Medical subject headings
- Rosacea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PAC-14028 cream 1%Drug
Also called PAC-14028
Participants received topical PAC-14028 cream 1% twice daily for 8 weeks
VehicleOther
Also called Vehicle of PAC-14028 Cream
Participants received topical Vehicle twice daily for 8 weeks
Rozex gel 0.75%Drug
Participants received topical Rozex gel 0.75% twice daily for 8 weeks
| Study group | Role | What they receive |
|---|---|---|
| PAC-14028 cream 1% | Experimental | PAC-14028 cream 1%, twice daily for 8 weeks Receives: Drug: PAC-14028 cream 1% |
| Rozex gel 0.75% | Active comparator | Rozex gel 0.75%, twice daily for 8 weeks Receives: Drug: Rozex gel 0.75% |
| Vehicle | Placebo comparator | Vehicle, twice daily for 8 weeks Receives: Other: Vehicle |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Investigator Global Assessment (IGA)
Measured: Baseline through Study Week 8
Secondary outcomes (3)
Erythema severity
Measured: Baseline through Study Week 8
Telangiectasia severity
Measured: Baseline through Study Week 8
Inflammatory lesion counts
Measured: Baseline through Study Week 8
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 startFeb 2013
- Primary completionJun 2013
- Study completionAug 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Erythematotelangiectatic RosaceaStudies 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
- 80 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
- NCT02052999
- Sponsor's protocol ID
- TRPV1-ROSACEA_IIT
- Status last verified
- Jan 2014
- First submitted
- 31 Jan 2014
- Last updated
- 3 Feb 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label Pilot Study to Evaluate the Efficacy of PAC-14028 in the Treatment of Erythematotelangiectatic Rosacea and Papulopustular Rosacea
- ClinicalTrials.gov ID
- NCT02052999
- Acronym / sponsor ID
- TRPV1-ROSACEA_IIT
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Amorepacific CorporationIndustry (pharma, biotech, devices)
- Study start
- Feb 2013
- Primary completion
- Jun 2013 (actual)
- Study completion
- Aug 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 is to determine the efficacy and safety of PAC-14028 1% cream of Amorepacific Corporation in patients with erythema-telangiectatic or papulopustular rosacea
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% | Experimental | Drug: PAC-14028 cream 1%PAC-14028 cream 1%, twice daily for 8 weeks |
| Rozex gel 0.75% | Active comparator | Drug: Rozex gel 0.75%Rozex gel 0.75%, twice daily for 8 weeks |
| Vehicle | Placebo comparator | Other: VehicleVehicle, twice daily for 8 weeks |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Male and female patients at the age of 20 to 65 years old
- Clinical diagnosis of erythematotelangiectatic or papulopustular rosacea according to National Rosacea Committee Expert Society with
- IGA score ≥ 2
- Voluntarily signed written informed consent forms for study participation
Key exclusion criteria (18 listed)
- Patients who are unable to be diagnosed or evaluated for rosacea due to tattoo or scar in the facial area
- Patients who are unable to be diagnosed or evaluated for rosacea due to excess hair(e.g., mustache, beard, whiskers etc.) in the facial area
- Patients who are sensitive to the drug or vehicle
- Previous administration of oral retinoid or vitamin A(≥10,000 units/day) within 6 months prior to visit 1
- Previous use of estrogen or oral contraceptives within 3 months prior to visit 1
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%Also: PAC-14028Participants received topical PAC-14028 cream 1% twice daily for 8 weeks | Drug | PAC-14028 cream 1% |
| VehicleAlso: Vehicle of PAC-14028 CreamParticipants received topical Vehicle twice daily for 8 weeks | Other | Vehicle |
| Rozex gel 0.75%Participants received topical Rozex gel 0.75% twice daily for 8 weeks | Drug | Rozex gel 0.75% |
Primary outcome
Change in Investigator Global Assessment (IGA)
Time frame: Baseline through Study Week 8
3 secondary outcomes
Erythema severity
Time frame: Baseline through Study Week 8
Telangiectasia severity
Time frame: Baseline through Study Week 8
Inflammatory lesion counts
Time frame: Baseline through Study Week 8
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 3 Feb 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.
BeomJoon Kim, Professor principal investigator
Department of Dermatology, Chungang 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 cream 1% and Rozex gel 0.75% in people with Erythematotelangiectatic Rosacea and Papulopustular Rosacea, 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 7 inclusion and 18 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 3 Feb 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 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 Investigator Global Assessment (IGA) (time frame: Baseline through Study Week 8). 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 3 Feb 2014.