Erythematotelangiectatic RosaceaPhase 2NCT01045551
Open Label Pilot Study of Apremilast in Treatment of Rosacea
A Phase 2 study testing Apremilast in people with Erythematotelangiectatic Rosacea and Papulopustular Rosacea, run by Julian M. Mackay-Wiggan at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Erythematotelangiectatic Rosacea, Papulopustular Rosacea
- What is being tested?
- Apremilast
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2010to Apr 2014
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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)
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- 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
- History of congenital or acquired immunodeficiency (common variable immunodeficiency (CVID) Hepatitis B surface antigen positive or Hepatitis B core antibody positive at screening
- History of human immunodeficiency virus (HIV) infection
- Antibodies to hepatitis C at screening
- Malignancy or history of malignancy (except for treated/cured basal cell skin carcinoma) greater than 3 years prior to screening
Trial locations and contacts
1 site in 1 country.
United States1 site
Columbia University Medical Center
New York, New York, 10032
About this study
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.
Read more
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.
Read the detailed description
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.
- Being tested
- Apremilast
- Keywords
- Inflammatory rosacea, Papules and pustules, Moderate to severe erythema, Telangiectasia
- Medical subject headings
- Rosacea, Telangiectasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ApremilastDrug
20mg taken orally twice per day for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| Apremilast 20 mg (twice per day) | Experimental | All subjects will receive Apremilast 20mg taken orally twice per day. Receives: Drug: Apremilast |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline to Week 12
Secondary outcomes (4)
Change in Physician 7 Point Global Assessment From Baseline to Week 12
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.
Measured: Baseline, week 12
Change From Baseline in Erythema Rating Visit 8 (Week 12)
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.
Measured: Baseline, Week 12
Change From Baseline in Telangiectasia Count at Visit 8 (Week 12)
physician count of telangiectasias on the face at visit 1 (baseline) compared to at visit 8 (week 12)
Measured: Baseline, Week 12
Change From Visit 8 (Week 12) in Telangiectasia Count at Visit 9 (Week 16)
Measured: Week 12, Week 16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2010 (estimated)
- Study startJun 2010
- Primary completionJan 2013
- Study completionApr 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Erythematotelangiectatic RosaceaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Julian M. Mackay-Wiggan
- Sponsor type
- University, hospital or other
- Collaborators
- Celgene Corporation
- Responsible party
- Sponsor-investigator, Julian M. Mackay-Wiggan, Columbia University
- Investigators
- Julian Mackay-Wiggan, MD, MS, Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01045551
- Sponsor's protocol ID
- AAAE1745
- Other IDs
- AP-ROS-PI 0033
- Status last verified
- Oct 2016
- First submitted
- 7 Jan 2010
- Last updated
- 13 Dec 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01045551
- Acronym / sponsor ID
- AAAE1745
- Keywords
- Inflammatory rosacea, Papules and pustules, Moderate to severe erythema, Telangiectasia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Julian M. Mackay-WigganUniversity, hospital or other
- Collaborators
- Celgene Corporation
- Study start
- Jun 2010
- Primary completion
- Jan 2013 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 11 Jan 2010 (estimated)
- Results
- Posted 4 Oct 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Apremilast 20 mg (twice per day) | Experimental | Drug: ApremilastAll subjects will receive Apremilast 20mg taken orally twice per day. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (29 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Apremilast20mg taken orally twice per day for 12 weeks | Drug | Apremilast 20 mg (twice per day) |
Primary outcome
Change From Baseline in the Total Number of Papulopustular Lesions at Week 12
Time frame: Baseline to 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
4 secondary outcomes
Change in Physician 7 Point Global Assessment From Baseline to Week 12
Time frame: Baseline, week 12
Change From Baseline in Erythema Rating Visit 8 (Week 12)
Time frame: Baseline, Week 12
Change From Baseline in Telangiectasia Count at Visit 8 (Week 12)
Time frame: Baseline, Week 12
Change From Visit 8 (Week 12) in Telangiectasia Count at Visit 9 (Week 16)
Time frame: Week 12, Week 16
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Julian Mackay-Wiggan, MD, MS principal investigator
Columbia University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Apremilast in people with Erythematotelangiectatic Rosacea and Papulopustular Rosacea, run by Julian M. Mackay-Wiggan at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 29 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 4 Oct 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline in the Total Number of Papulopustular Lesions at Week 12 (time frame: Baseline to Week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Dec 2016.