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

Amorepacific

Status and phase: Completed; Phase 2

Conditions: Atopic Dermatitis

Treatments: Drug: Elidel cream 1%; Drug: PAC-14028 cream vehicle; Drug: PAC-14028 cream 1.0%

Study type: Interventional

Funder types: Industry

Identifiers

NCT02583022

TRPV1-AD_IIT

Details and patient eligibility

About

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.

Enrollment: 74 patients

Sex: All

Ages: 20 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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74 participants in 3 patient groups, including a placebo group

PAC-14028 cream 1.0%

Experimental group

Description:

PAC-14028 cream 1.0%, Twice daily for 4 weeks

Treatment:

Drug: PAC-14028 cream 1.0%

PAC-14028 cream vehicle

Placebo Comparator group

Description:

PAC-14028 cream vehicle, Twice daily for 4 weeks

Treatment:

Drug: PAC-14028 cream vehicle

Elidel cream 1%

Active Comparator group

Description:

Elidel cream 1%, Twice daily for 4 weeks

Treatment:

Drug: Elidel cream 1%