Multi center, double-blind, randomized, placebo controlled parallel-group clinical trial to evaluate antirosacea effect and safety of PAC-14028 cream in rosacea patients

Multi center, double-blind, randomized, placebo controlled parallel-group, dose finding phase II clinical trial to evaluate antirosacea effect and safety of PAC-14028 cream(0.1%, 0.3%, 1.0%) in rosacea patients

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

CRIS

Registry ID

KCT0001705

Enrollment

216

Registered

2015-11-24

Start date

2014-11-24

Completion date

Unknown

Last updated

2019-03-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Drug : Dose: PAC-14028 Cream 0.1%, 0.3%, 1.0%, Vehicle ?? Treatment: Topical application of 1 fingertip unit each time twice daily in the morning and the evening for 4 weeks

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: •Male and female patients aged 19 - 70 years old •Among the patients diagnosed with erythematotelangiectatic and papulopustular rosacea in accordance with the diagnostic criteria of the National Rosacea Society Expert Committee •Subjects with rosacea scored 2 or more according to the Investigator Global Assessment (IGA) at screening

Exclusion criteria

Exclusion criteria: •Those who can't be diagnosed or assessed for rosacea due to the presence of trauma, tattoo, scar, excessive hairs on the facial region •Those who have received a facial laser treatment within 6 weeks •Those who have been administered with oral retinoid or therapeutic vitamin A within 6 months •Those who have received a hormonal treatment such as estrogen within 3 months •Those who have been administered with systemic antibiotics or systemic steroid formulation within 4 weeks •Those who have been administered with local retinoid, local steroid and local antibiotics and local medication for the treatment of rosacea on face within 4 weeks •Those who have a history of blood disorder that can have a serious effect on the clinical study •Women who are pregnant, lactating or who plan to be pregnant during the clinical study period or women of childbearing potential who do not use available contraceptive methods

Design outcomes

Primary

Measure	Time frame
Change in Investigator Global Assessment	—

Secondary

Measure	Time frame
Change in the erythema severity;Rate of change in inflammatory lesion counts ;Change in erythema index;Change in the telangiectasia severity	—

Countries

Korea, Republic of

Contacts

Public ContactIl-Hwan Kim

Korea University Ansan Hospital

Outcome results