Apremilast in the Treatment of Moderate to Severe Acne

Part of paid clinical trials in Chapel Hill, North Carolina.

Sponsor
University of North Carolina, Chapel Hill
Study ID
NCT01074502
Phase
PHASE2
Status
Terminated

Conditions

  • Acne

Eligibility Criteria

Sex
ALL
Age
18 Years - 45 Years
Healthy Volunteers
Accepted

Interventions

  • apremilast — DRUG
    apremilast 20 mgs orally twice a day for 12 weeks

Study Details

Acne is a chronic inflammatory disease of the pilosebaceous unit that affects 80-90% of the population, especially teenagers, although adult acne is a significant problem for 3-6 % of adult men and 5-12% of adult women. Although acne is not a life-threatening disease, it produces significant psychological disturbances and permanent skin scars. A novel anti-inflammatory, not antibiotic drug may be an excellent alternative for the treatment of moderate to severe acne. Apremilast has been shown to inhibit the production of tumor necrosis factor (TNF)-alpha, IL-8 and neutrophil infiltration, all of which are elevated in inflammatory acne. Our intention is to study Apremilast in the treatment of moderate to severe acne.

Key Dates

First listed
Feb 24, 2010
Start date
Feb 28, 2010
Status verified
Feb 2017
Primary completion
Jul 31, 2010
Completion
Oct 31, 2010

Study Design

Enrollment
3 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: apremilast
    apremilast 20 mgs twice a day for 12 weeks

Primary Outcome Measure

Percentage of Patients With a Success Rate (Based on the Researcher's Global Assessment (RGA) Sum of Clear (0) or Almost Clear (1)) [ Time Frame: Baseline to 16 weeks ]

Locations (1)

FacilityCityStateZIPSite coordinators
University Of North CarolinaChapel HillNorth Carolina27516-

Find similar trials in Chapel Hill, NC

By research site
University Of North Carolina· Chapel Hill, NC

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