Papulopustular Rosacea Clinical Trial
Official title:
An Open Label, Pilot Study to Determine the Efficacy of Apremilast in the Treatment of Rosacea in Patients With Both Erythematotelangiectatic Rosacea and Papulopustular Rosacea
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.
This is a single-center, open label pilot study of Apremilast in ten subjects with both
erythematotelangiectatic rosacea and papulopustular rosacea in which subjects will be
treated with Apremilast 20mg twice per day for 12 weeks. There is a total of 10 visits over
a period of 16 weeks.
Adult male and female subjects 18 years of age or older will participate in the study after
the objectives, methods, and potential hazards of the study have been fully explained, and
after they have signed the informed consent form. Subjects must have a diagnosis or findings
consistent with erythematotelangiectatic and papulopustular rosacea. Subjects must have at
least 10 papulopustular lesions with underlying erythema/telangiectasias visible to the
unassisted naked eye.
Subjects will take Apremilast capsules 20mg twice per day for 12 weeks. If at anytime during
the study a subject encounters overt study medication related adverse effects, dose
reduction will be allowed following discussions between the subject and the investigator.
Dose reductions to 20mg once per day will be allowed for subjects who experience intolerable
adverse effects from the study medication. If the subject cannot tolerate 20mg per day,
he/she will be terminated from the study.
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Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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