Atopic Dermatitis — Study of Apremilast in Atopic or Contact Dermatitis
Citation(s)
Belloni B, Andres C, Ollert M, Ring J, Mempel M Novel immunological approaches in the treatment of atopic eczema. Curr Opin Allergy Clin Immunol. 2008 Oct;8(5):423-7. doi: 10.1097/ACI.0b013e32830fb8fd. Review.
Cone RE, Li X, Sharafieh R, O'Rourke J, Vella AT The suppression of delayed-type hypersensitivity by CD8+ regulatory T cells requires interferon-gamma. Immunology. 2007 Jan;120(1):112-9. Epub 2006 Oct 18.
Gottlieb AB, Strober B, Krueger JG, Rohane P, Zeldis JB, Hu CC, Kipnis C An open-label, single-arm pilot study in patients with severe plaque-type psoriasis treated with an oral anti-inflammatory agent, apremilast. Curr Med Res Opin. 2008 May;24(5):1529-38. doi: 10.1185/030079908X301866 . Epub 2008 Apr 16.
A Phase 2, Open-label, Investigator-Initiated Study to Evaluate the Safety and Efficacy of Apremilast in Subjects With Recalcitrant Contact or Atopic Dermatitis
Interventional studies are often prospective and are specifically tailored to evaluate direct impacts of treatment or preventive measures on disease.
Observational studies are often retrospective and are used to assess potential causation in exposure-outcome relationships and therefore influence preventive methods.
Expanded access is a means by which manufacturers make investigational new drugs available, under certain circumstances, to treat a patient(s) with a serious disease or condition who cannot participate in a controlled clinical trial.
Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.
Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.
