Study to Evaluate the Efficacy and Safety of PAC-14028 Cream in Rosacea Patients

January 31, 2014 updated by: Amorepacific Corporation

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
80

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

20 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: PAC-14028 cream 1%
PAC-14028 cream 1%, twice daily for 8 weeks
Drug: PAC-14028 cream 1%
Participants received topical PAC-14028 cream 1% twice daily for 8 weeks
Other Names:
  • PAC-14028
ACTIVE_COMPARATOR: Rozex gel 0.75%
Rozex gel 0.75%, twice daily for 8 weeks
Drug: Rozex gel 0.75%
Participants received topical Rozex gel 0.75% twice daily for 8 weeks
PLACEBO_COMPARATOR: Vehicle
Vehicle, twice daily for 8 weeks
Other: Vehicle
Participants received topical Vehicle twice daily for 8 weeks
Other Names:
  • Vehicle of PAC-14028 Cream

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Change in Investigator Global Assessment (IGA)
Time Frame: Baseline through Study Week 8
Baseline through Study Week 8

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Erythema severity
Time Frame: Baseline through Study Week 8
Baseline through Study Week 8
Telangiectasia severity
Time Frame: Baseline through Study Week 8
Baseline through Study Week 8
Inflammatory lesion counts
Time Frame: Baseline through Study Week 8
Baseline through Study Week 8

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Amorepacific Corporation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2013

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2013

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 1, 2013

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 31, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 31, 2014

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 3, 2014

Study Record Updates

Last Update Posted (ESTIMATE)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 3, 2014

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 31, 2014

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • TRPV1-ROSACEA_IIT

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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