Open Label Pilot Study of Apremilast in Treatment of Rosacea

Inclusion Criteria

• •Must be a healthy, post-pubescent male or female 18 years of age or older with moderate to severe erythematotelangiectatic and papulopustular rosacea, defined as 10 to 40 papules and pustules
• •Must have presence of moderate to severe erythema
• •Must have presence of telangiectasia
• •Must have a diagnosis or findings consistent with a diagnosis of erythematotelangiectatic rosacea and papulopustular rosacea
• •Must understand and voluntarily sign an informed consent form
• •Must be ale to adhere to the study visit schedule and other protocol requirements
• •Must be able to restrict diet in order to avoid foods/drinks that are known triggers that would exacerbate the signs/symptoms of rosacea
• •Must have within normal range for routine blood laboratory tests
• •Females of childbearing potential must have a negative urine pregnancy test at screening and if sexually active must agree to use two(2) forms of contraception (adequate forms of contraception are outlined in the protocol)
• •Females of childbearing potential must agree to serum pregnancy tests every 4 weeks while on study medication
• •Males (including those who have had a vasectomy) must agree to use barrier contraception (latex condoms) when engaging in sexual activity with females of childbearing potential while on study medication and for 84 days after taking the last dose of study medication
• •Initiation of a hormonal method of birth contraception within 4 months of baseline, discontinuation during the course of the study, or change in the product within 4 months of baseline during the study
• •Subject is a woman who is perimenopausal whos symptoms cause flushing that may affect the rosacea
• •Systemic fungal infection
• •History of active mycobacterial infection with any species within 3 years prior to screening, subjects with mycobacterium tuberculosis infection more than 3 years prior to screening are allowed if successful treatment was completed at least 3 years prior to randomization and is documented and available for verification
• •Latent mycobacterium tuberculosis infection as indicated by a positive purified protein derivative (PPD) skin test. Subjects with a positive PPD skin test and documented completion of treatment for latent TB are eligible. Subjects with a positive PPD skin test and not treated or no documentation of completion of treatment are ineligible
• •History of incompletely treated mycobacterium tuberculosis infection as indicated by: a)subject's medical records documenting incomplete treatment for mycobacterium tuberculosis b)subject's self reported history of incomplete treatment for mycobacterium tuberculosis
• •History of recurrent bacterial infection (at least 3 major infections resulting in hospitalization and/or requiring intravenous antibiotic treatment within the past 2 years)
• •Clinically significant abnormality on the chest x-ray at screening, chest x-rays performed within 3 months prior to start of study drug are acceptable
• •Any clinically significant abnormality on 12-lead electrocardiogram at screening
• •History of congenital or acquired immunodeficiency (common variable immunodeficiency (CVID) Hepatitis B surface antigen positive or Hepatitis B core antibody positive at screening
• •History of human immunodeficiency virus (HIV) infection
• •Antibodies to hepatitis C at screening
• •Malignancy or history of malignancy (except for treated/cured basal cell skin carcinoma) greater than 3 years prior to screening