Open Label Pilot Study of Apremilast in Treatment of Rosacea

NCT01045551 | Completed Phase 2 Results

• 2 other identifiers: AAAE1745AP-ROS-PI 0033
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Erythematotelangiectatic Rosacea; Papulopustular Rosacea

Keywords

Inflammatory rosacea; Papules and pustules; Moderate to severe erythema; Telangiectasia

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in the Total Number of Papulopustular Lesions at Week 12

  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

  Baseline to Week 12

Secondary Outcomes (4)

• Change in Physician 7 Point Global Assessment From Baseline to Week 12

  Baseline, week 12

• Change From Baseline in Erythema Rating Visit 8 (Week 12)

  Baseline, Week 12

• Change From Baseline in Telangiectasia Count at Visit 8 (Week 12)

  Baseline, Week 12

• Change From Visit 8 (Week 12) in Telangiectasia Count at Visit 9 (Week 16)

  Week 12, Week 16

Study Arms (1)

Apremilast 20 mg (twice per day)

EXPERIMENTAL

All subjects will receive Apremilast 20mg taken orally twice per day.

Drug: Apremilast

Interventions

Apremilast DRUG

20mg taken orally twice per day for 12 weeks

Apremilast 20 mg (twice per day)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Julian M. Mackay-Wiggan: lead
• Celgene Corporation: collaborator

Study Sites (1)

Columbia University Medical Center

New York, New York, 10032, United States

Location

MeSH Terms

Conditions

Rosacea; Telangiectasis

Interventions

apremilast

Condition Hierarchy (Ancestors)

Skin Diseases; Skin and Connective Tissue Diseases; Vascular Diseases; Cardiovascular Diseases

Results Point of Contact

• Title: Julian Mackay-Wiggan, MD, MS
• Organization: Columbia University Medical Center

jc299@cumc.columbia.edu

212-305-6953

Study Officials

• Julian Mackay-Wiggan, MD, MS

  Columbia University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Clinical Professor of Dermatology

Study Record Dates

• First Submitted: January 7, 2010
• First Posted: January 11, 2010
• Study Start: June 1, 2010
• Primary Completion: January 1, 2013
• Study Completion: April 1, 2014
• Last Updated: December 13, 2016
• Results First Posted: October 4, 2016

Record last verified: 2016-10

Locations

US (1)