Open Label Pilot Study of Apremilast in Treatment of Rosacea
Status:
Completed
Trial end date:
2014-04-01
Target enrollment:
Participant gender:
Summary
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.