Apremilast for Atopic Dermatitis - A Pilot Study in Adults

Sponsor
Oregon Health and Science University
Study ID
NCT01393158
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Apremilast — DRUG
    20mg of Apremilast taken orally BID for 3 months or 30 mg of Apremilast taken orally BID for 6 months.

Study Details

The purpose of this study is to obtain preliminary data regarding the safety and tolerability of apremilast in AD to support the design of larger controlled studies.

Key Dates

First listed
Jul 13, 2011
Start date
May 31, 2009
Status verified
Dec 2019
Primary completion
Jul 31, 2011
Completion
Jul 31, 2011

Study Design

Enrollment
16 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: 20 mg BID
    Patients dosed with 20 mg orally of Apremilast BID for 3 months.
  • Experimental: 30 mg BID
    Patients dosed with 30 mg orally of Apremilast BID for 6 months.

Primary Outcome Measure

Change in EASI Scores [ Time Frame: Mean change in EASI score measured at Baseline and Month 3, (if on 20mg arm) or Baseline and Month 6 (if on 30mg arm) ]

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