Acne VulgarisPhase 2NCT00098358
Study of Oral Zileuton in the Treatment of Moderate to Severe Facial Acne Vulgaris
A Phase 2 study testing Zileuton in people with Acne Vulgaris, run by Critical Therapeutics at 12 sites in United States.
Trial summary
Tissue inflammation is a major component of the acne disease process. Leukotriene B4 (LTB4) is thought to be a major player in the development of tissue inflammation. Synthesis of LTB4 is controlled by the enzyme 5-lipoxygenase. Zileuton blocks the activity of 5-lipoxygenase. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Acne Vulgaris
- What is being tested?
- Zileuton
- How many people
- 90 participants
- Where
- 12 sitesUnited States
- Study dates
- Nov 2004to May 2005
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Moderate to severe facial acne vulgaris
- 20 to 60 facial inflammatory lesions
- 10 to 200 facial non-inflammatory lesions
- No more than 3 facial nodular cystic lesions
Who cannot join
- Uncontrolled systemic disease
- Use of systemic or topical acne therapy within 14 days of study
- Use of systemic retinoids within past 2 years
- Skin diseases that interfere with acne counts
- Active liver disease
- Screening elevations in liver function tests
Show all 10Show fewer
- Positive serology for hepatitis B or C
- Use of theophylline, warfarin, or propranolol within 7 days of study
- Use of Singulair or Accolate within 14 days of study
- Female patients who are pregnant or nursing
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
United States12 sites
Academic Dermatology Associates
Albuquerque, New Mexico, 87106
DermResearch, Inc.
Austin, Texas, 78759
SUNY Downstate Medical Center
Brooklyn, New York, 11203
J&S Studies, Inc.
Bryan, Texas, 77802
Minnesota Clinical Study Center
Fridley, Minnesota, 55432
Rivergate Dermatology
Goodlettsville, Tennessee, 37072
Milton S. Hersey Medical Center
Hersey, Pennsylvania, 17033-0850
Dermatology Specialists, PSC
Louisville, Kentucky, 40202
MedaPhase, Inc.
Newnan, Georgia, 30263
Virginia Clinical Research, Inc.
Norfolk, Virginia, 23507
Dermatology Associates of Rochester
Rochester, New York, 14623
Therapeutics Clinical Research
San Diego, California, 92123
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Clinical Proof of Concept Study of Zileuton IR in Patients With Moderate to Severe Facial Acne Vulgaris
Tissue inflammation is a major component of the acne disease process. Leukotriene B4 (LTB4) is thought to be a major player in the development of tissue inflammation. Synthesis of LTB4 is controlled by the enzyme 5-lipoxygenase. Zileuton blocks the activity of 5-lipoxygenase. This study will test the safety and efficacy of zileuton in the treatment of facial acne.
- Conditions
- Acne Vulgaris
- Being tested
- Zileuton
- Keywords
- Leukotrienes, inflammation
- Medical subject headings
- Acne Vulgaris, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ZileutonDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in number of inflammatory lesions
Secondary outcomes (4)
Physician's global assessment scale
Change in number of non-inflammatory lesions
Change in total numbers of lesions
Change in sebum production
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2004 (estimated)
- Study startNov 2004
- Study completionMay 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acne VulgarisStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 90 participants
Sponsor and investigators
- Lead sponsor
- Critical Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Walter Newman, Ph.D., Study director, Critical Therapeutics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00098358
- Sponsor's protocol ID
- CTI-02-C04-201
- Status last verified
- Feb 2007
- First submitted
- 7 Dec 2004
- Last updated
- 7 Feb 2007
- Results posted
- No
Publications
Zouboulis CC, Nestoris S, Adler YD, Orth M, Orfanos CE, Picardo M, Camera E, Cunliffe WJ. A new concept for acne therapy: a pilot study with zileuton, an oral 5-lipoxygenase inhibitor. Arch Dermatol. 2003 May;139(5):668-70. doi: 10.1001/archderm.139.5.668. No abstract available.
PubMed 12756111
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Clinical Proof of Concept Study of Zileuton IR in Patients With Moderate to Severe Facial Acne Vulgaris
- ClinicalTrials.gov ID
- NCT00098358
- Acronym / sponsor ID
- CTI-02-C04-201
- Conditions
- Acne Vulgaris
- Keywords
- Leukotrienes, inflammation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants
- Lead sponsor
- Critical TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- Nov 2004
- Study completion
- May 2005
- First posted
- 8 Dec 2004 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Tissue inflammation is a major component of the acne disease process. Leukotriene B4 (LTB4) is thought to be a major player in the development of tissue inflammation. Synthesis of LTB4 is controlled by the enzyme 5-lipoxygenase. Zileuton blocks the activity of 5-lipoxygenase. This study will test the safety and efficacy of zileuton in the treatment of facial acne.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Moderate to severe facial acne vulgaris
- 20 to 60 facial inflammatory lesions
- 10 to 200 facial non-inflammatory lesions
- No more than 3 facial nodular cystic lesions
Key exclusion criteria (10 listed)
- Uncontrolled systemic disease
- Use of systemic or topical acne therapy within 14 days of study
- Use of systemic retinoids within past 2 years
- Skin diseases that interfere with acne counts
- Active liver disease
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 |
|---|---|---|
| Zileuton | Drug | – |
Primary outcome
Change in number of inflammatory lesions
4 secondary outcomes
Physician's global assessment scale
Change in number of non-inflammatory lesions
Change in total numbers of lesions
Change in sebum production
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2007.
- Background: PubMed 12756111Zouboulis CC, Nestoris S, Adler YD, Orth M, Orfanos CE, Picardo M, Camera E, Cunliffe WJ. A new concept for acne therapy: a pilot study with zileuton, an oral 5-lipoxygenase inhibitor. Arch Dermatol. 2003 May;139(5):668-70. doi: 10.1001/archderm.139.5.668. No abstract available.
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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.
Walter Newman, Ph.D. study director
Critical Therapeutics
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Zileuton in people with Acne Vulgaris, run by Critical Therapeutics at 12 sites 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 4 inclusion and 10 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: status not confirmed, as of the sponsor's last update on 7 Feb 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites 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?
Results are not available in the source record.
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 in number of inflammatory lesions. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00098358, which also lists 1 linked publication.
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 7 Feb 2007.