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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

74 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-06-30

Study Completion Date

2015-08-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Atopic Dermatitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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PAC-14028 cream 1.0%

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

Group Type EXPERIMENTAL

PAC-14028 cream 1.0%

Intervention Type DRUG

Topical application

PAC-14028 cream vehicle

PAC-14028 cream vehicle, Twice daily for 4 weeks

Group Type PLACEBO_COMPARATOR

PAC-14028 cream vehicle

Intervention Type DRUG

Topical application

Elidel cream 1%

Elidel cream 1%, Twice daily for 4 weeks

Group Type ACTIVE_COMPARATOR

Elidel cream 1%

Intervention Type DRUG

Topical application

Interventions

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PAC-14028 cream 1.0%

Topical application

Intervention Type DRUG

PAC-14028 cream vehicle

Topical application

Intervention Type DRUG

Elidel cream 1%

Topical application

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

20 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No