A Study to Evaluate the Safety and Efficacy of PAC-14028 Cream in Atopic Dermatitis

• Status: Completed
• Trial end date: 2015-08-01
• Target enrollment: 0
• Participant gender: All

Summary

The study is a Phase II, single center, randomized, open-label, placebo-controlled study in male and female subjects, aged ≥ 20 years with mild to moderate atopic dermatitis. All subjects will receive BID topical applications of PAC-14028 cream or vehicle or Elidel cream for up to 4 weeks.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Amorepacific Corporation
• Treatments: Pimecrolimus

Criteria

Inclusion Criteria:

• Male or female patients aged between 20 and 65 years old

• Patients with atopic dermatitis, diagnosed according to Hanifin and Rajka diagnostic criteria

• SCORAD (SCORing Atopic Dermatitis) Score less than 40

Exclusion Criteria:

• Patients presenting symptoms of systemic infection at screening

• Patients who had been treated with oral steroids, oral antibiotics, systemic phototherapy, or immunosuppressants within the last 1 month prior to the investigational product administration

• Patients who had been treated with topical steroids or antibiotics within the last 2 weeks prior to the investigational product administration

• Pregnant women or breastfeeding women

• Women of childbearing potential or women who are planning a pregnancy during the study