Open Label Pilot Study of Apremilast in Treatment of 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.
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|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|
- Change From Baseline in the Total Number of Papulopustular Lesions at Week 12 [ Time Frame: Baseline to Week 12 ] [ Designated as safety issue: No ]Papule and pustule count consisted of direct measurement of the number of papules/pustules on the face. Papule and pustule count, compared between baseline and end of treatment Week 12 was calculated
- Change in Physician 7 Point Global Assessment From Baseline to Week 12 [ Time Frame: Baseline, week 12 ] [ Designated as safety issue: No ]The Physician Global 7-point Assessment. Scale range: 0-7. 0 = clear, 1 = minimal, 2 = mild, 3 = mild to moderate, 4= moderate, 5= moderate to severe, 6 = severe. 0 is a better outcome, 6 is a worse outcome. No subscales were used.
- Change From Baseline in Erythema Rating Visit 8 (Week 12) [ Time Frame: Baseline, Week 12 ] [ Designated as safety issue: No ]The change in the Physician Overall Erythema Severity. Scale range 0 - 3. 0 = none/absent, 1 = mild, 2 = moderate, 3 = severe. 0 is considered a better outcome, 3 is considered a worse outcome.
- Change From Baseline in Telangiectasia Count at Visit 8 (Week 12) [ Time Frame: Baseline, Week 12 ] [ Designated as safety issue: No ]physician count of telangiectasias on the face at visit 1 (baseline) compared to at visit 8 (week 12)
- Change From Visit 8 (Week 12) in Telangiectasia Count at Visit 9 (Week 16) [ Time Frame: Week 12, Week 16 ] [ Designated as safety issue: No ]
|Study Start Date:||June 2010|
|Study Completion Date:||April 2014|
|Primary Completion Date:||January 2013 (Final data collection date for primary outcome measure)|
Experimental: Apremilast 20 mg (twice per day)
All subjects will receive Apremilast 20mg taken orally twice per day.
20mg taken orally twice per day for 12 weeks
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01045551
|United States, New York|
|Columbia University Medical Center|
|New York, New York, United States, 10032|
|Principal Investigator:||Julian Mackay-Wiggan, MD, MS||Columbia University|