Open Label Pilot Study of Apremilast in Treatment of Rosacea

Completed · Phase 2

Conditions studied: Erythematotelangiectatic Rosacea, Papulopustular Rosacea

In brief

Rosacea is a chronic skin disorder with the signs and symptoms of facial flushing, persistent redness, small visible spider-like veins, papules (inflamed red bumps under the skin) and pustules. Rosacea is also a a recurring skin disorder. In addition to causing uncomfortable and embarrassing physical symptoms such as flushing, burning, and itching, rosacea can also contribute to lower self-esteem, which can have a significant psychosocial impact on quality of life. Rosacea flares can be triggered by every day factors such as sun exposure, heat, hot or caffeinated drinks, alcoholic beverages, spices and stress. Many of the currently available treatments for rosacea are only partially effective and some patients do not respond to them, or are unable to tolerate the side effects. This is a single-center, open label trial of Apremilast in ten (10) subjects with moderate to severe inflammatory rosacea who will be treated with Apremilast 20 mg twice per day for 12 weeks. Following the screening period and baseline visit, study subjects will return at weeks 1, 2, 4, 6, 8, 10 and 12. There is a follow up study visit at week 16. Recent research has shown an increase of specific proinflammatory cytokines in the biopsies of inflammatory lesions from rosacea and acne patients. The cytokines then trigger a chain of chemical responses in the body that likely result in the development of the papules an pustules that are seen in rosacea and acne patients. Apremilast is an oral agent that modulates multiple anti-inflammatory pathways and has pharmacodynamic properties with potential therapeutic benefit for treating inflammatory autoimmune disorders. The investigators therefore propose a pilot study to evaluate the potential for Apremilast to improve the signs and symptoms of moderate to severe inflammatory rosacea.

Key facts

Study ID: NCT01045551
Run by: Julian M. Mackay-Wiggan
People needed: 10
Starts: 2010-06-01
Expected to finish: 2014-04-01
Last updated by the study team: 2016-12-13

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

Inability to provide voluntary consent
Diagnosis of acne vulgaris or perioral dermatitis
Use of topical acne or rosacea treatments within 4 weeks of baseline
Use of systemic retinoids within 90 days of baseline
Known or suspected excessive alcohol intake (which in the opinion of the investigator will exacerbate the signs and symptoms of rosacea)
Use of any investigational medication within 4 weeks prior to start of study drug or 5 pharmacokinetic/pharmacodynamic half-lives (whichever is longer)
A known sensitivity to tetracyclines
Currently taking clinically significant concomitant drug therapy
Use of any acne or rosacea treatment during the course of the study or within four weeks of starting the study medication, including azelaic acid, topical or systemic retinoids, sulfa drugs, erythromycin, cephalosporins, quinolones, tetracycline, benzoyl peroxide products, as well as pulse dye laser, intense pulsed light and photodynamic therapy
Current use and inability to discontinue use of PDE 4 inhibitors, theophylline, systemic steroids (oral or inhaled), penicillin antibiotics, niacin greater than 500 mg/day, chronic use of NSAIDS, or use of any medication that in the opinion of the investigator affects the severity of rosacea
Long-term use (greater than 14 days) of topical or systemic anti-inflammatories in the 4 weeks prior to baseline and during the study. Chronic use of aspirin at sub-analgesic doses (less than 325 mg once daily) is acceptable for patients requiring platelet aggregation inhibition
Use of topical or systemic corticosteroids 4 weeks prior to baseline and during the study
Patients with ocular rosacea and/or blepharitis/meibomianitis who required treatment by an ophthalmologist
Patients who had surgeries that bypassed or excluded the duodenum
Any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study
Pregnant or breastfeeding women, or women of childbearing potential who are not using an adequate form of birth control as described in the inclusion criteria
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

Where it is running

Columbia University Medical Center — New York, New York, United States

Full record on ClinicalTrials.gov

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