RosaceaPhase 2NCT00249782
A Phase II, Randomized Study of ACZONE™ (Dapsone) Gel, 5% for Papulopustular Rosacea.
A Phase 2 study testing ACZONE (dapsone) Gel, 5%, 2x/day, ACZONE (dapsone) Gel, 5%, 1x/day and MetroGel® (metronidazole gel), 1.0% 1x/day in people with Rosacea, run by Allergan at 26 sites in United States.
Trial summary
The purpose of this study is to evaluate the safety and effectiveness of ACZONE™ gel compared to placebo (inactive substance), MetroGel® and a combination of ACZONE™ gel and MetroGel® for the treatment of rosacea. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rosacea
- What is being tested?
- ACZONE (dapsone) Gel, 5%, 2x/day, ACZONE (dapsone) Gel, 5%, 1x/day and MetroGel® (metronidazole gel), 1.0% 1x/day
- How many people
- 400 participants
- Where
- 26 sitesUnited States
- Study dates
- Nov 2005to May 2006
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- To be eligible for the study, subjects must fulfill all of the following criteria:
- Men or women ≥18 years of age.
- A diagnosis of papulopustular rosacea, with ≥10 inflammatory lesions (papules and/or pustules) above the mandibular line at baseline.
- An Investigator Global Assessment (IGA) score ≥2
- In good physical and mental health.
- Signature of an approved informed consent form for the study and HIPAA authorization (if applicable).
- Willingness to comply with the protocol.
Who cannot join
- Subjects meeting any of the following criteria will be excluded from the study:
- A skin examination reveals the presence of another skin disease and/or condition (excessive facial hair, excessive scarring, sunburn, or other disfigurement) located on the face that would confound the evaluation of the rosacea condition.
- Current or past ocular rosacea, such as conjunctivitis, iritis, and keratitis, of sufficient severity to require topical or systemic antibiotics.
- Treatment with topical antibiotics, topical steroids and other topical rosacea treatments on the face within 14 days of Baseline and throughout the study.
- Treatment with systemic steroids within 30 days of Baseline and throughout the study.
- Treatment with any systemic antibiotics within 30 days of Baseline and throughout the study.
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- Treatment with any systemic medication or therapy known to affect inflammatory responses within the 30 days prior to Baseline or throughout the study.
- Treatment with topical retinoids within 30 days or systemic retinoids within 180 days of Baseline and throughout the study.
- Treatment with physical modalities that could benefit rosacea are prohibited within 30 days of Baseline and throughout the study.
Trial locations and contacts
26 sites in 1 country.
26 sites in 1 country
United States26 sites
Academic Dermatology Associates
Albuquerque, New Mexico, 87106
DermResearch, Inc.
Austin, Texas, 78759
Radiant Research
Birmingham, Alabama, 35209
Visions Clinical Research
Boynton Beach, Florida, 33437
J&S Studies Inc.
Bryan, Texas, 77802
University Dermatology Consultants, Inc.
Cincinnati, Ohio, 45219
Dermatology Research Associates Inc.
Cincinnati, Ohio, 45230
Tampa Bay Medical Research
Clearwater, Florida, 33761
Cherry Creek Research, Inc
Denver, Colorado, 80246
Welborn Clinic
Evansville, Indiana, 478713
East Bay Dermatology Medical Group, Inc.
Fremont, California, 94538
Dermatology Consulting Services
High Point, North Carolina, 27262
Madison Skin & Research, Inc.
Madison, Wisconsin, 53719
FXM Research
Miami, Florida, 33175
Dermatology Research Association, Inc.
Nashville, Tennessee, 37203
The Savin Center, PC
New Haven, Connecticut, 06511
MedaPhase, Inc.
Newnan, Georgia, 30263
Skin Specialists, PC
Omaha, Nebraska, 68144
University Clinical Research, Inc.
Pembroke Pines, Florida, 33024
Paddington Testing Co., Inc.
Philadelphia, Pennsylvania, 19103
Northwest Dermatology and Research Center
Portland, Oregon, 97210
Oregon Medical Research Center
Portland, Oregon, 97223
Therapeutics Clinical Research
San Diego, California, 92123
Clincial Research Specialists, Inc.
Santa Monica, California, 90404
Dermatology Clinical Trials Unit Washington University
St Louis, Missouri, 63110
Radiant Research
Tucson, Arizona, 85710
About this study
Official title: A Phase II, Randomized, Partial-Blind, Parallel-Group, Active- and Vehicle-Controlled, Multicenter Study of the Safety and Efficacy of ACZONE™ (Dapsone) Gel, 5% in Subjects With Papulopustular Rosacea
The purpose of this study is to evaluate the safety and effectiveness of ACZONE™ gel compared to placebo (inactive substance), MetroGel® and a combination of ACZONE™ gel and MetroGel® for the treatment of rosacea.
ACZONE™ gel, 5% is a topical (applied to the skin) medication that is approved by the United States Food and Drug Administration (FDA) for the treatment of acne vulgaris in people 12 years and older. The use of ACZONE™ for the treatment of rosacea is investigational. An investigational use is one that is not approved by the FDA.
Subjects will apply the study treatment for 12 weeks. Efficacy assessments will be performed at baseline and Weeks 2, 4, 8, and 12. Laboratory assessments will be conducted at baseline and Week, 2, 4 and 12.
Read the detailed description
Study Objective:
•To evaluate the safety and preliminary efficacy of ACZONE in subjects with papulopustular rosacea
Study Population: Approximately 400 male and female subjects will be enrolled at 27 study centers in the United States.
Study Treatment: Subjects will be randomized to 1 of 5 treatment regimens. Subjects will receive study medication for 12 weeks. Study participation is 13 weeks (5 clinic visits and 1 telephone follow-up).
- Conditions
- Rosacea
- Being tested
- Vehicle control, 2x/day, ACZONE (dapsone) Gel, 5%, 2x/day, ACZONE (dapsone) Gel, 5%, 1x/day, MetroGel® (metronidazole gel), 1.0% 1x/day, ACZONE (dapsone) Gel, 5%, 1x/day (AM) + MetroGel (metronidazole gel), 1.0%, 1x/day (PM)
- Keywords
- rosacea, Papulopustular Rosacea,erythema, dapsone
- Medical subject headings
- Rosacea, Erythema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vehicle control, 2x/dayDrug
ACZONE (dapsone) Gel, 5%, 2x/dayDrug
ACZONE (dapsone) Gel, 5%, 1x/dayDrug
MetroGel® (metronidazole gel), 1.0% 1x/dayDrug
ACZONE (dapsone) Gel, 5%, 1x/day (AM) + MetroGel (metronidazole gel), 1.0%, 1x/day (PM)Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy: Percent change and change from baseline in inflammatory lesion counts;
"Success" rate, defined as proportion of subjects with a score of 0 or 1 and at least a 2 point improvement from baseline on the IGA scale;
Erythema & telangiectasia scores;
Lesion counts over time
Secondary outcomes (2)
Safety: Adverse events and concomitant medications; Local symptom scores; Hematology and chemistry laboratory parameters; Vital signs
Other: Plasma dapsone concentrations
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2005 (estimated)
- Study startNov 2005
- Primary completionMay 2006
- Study completionMay 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Enrolment
- 400 participants (actual)
Sponsor and investigators
- Lead sponsor
- Allergan
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Steven Garrett, MS, DDS, Study director, QLT USA, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00249782
- Sponsor's protocol ID
- ACZ ROS 01
- Status last verified
- May 2011
- First submitted
- 3 Nov 2005
- Last updated
- 30 May 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II, Randomized, Partial-Blind, Parallel-Group, Active- and Vehicle-Controlled, Multicenter Study of the Safety and Efficacy of ACZONE™ (Dapsone) Gel, 5% in Subjects With Papulopustular Rosacea
- ClinicalTrials.gov ID
- NCT00249782
- Acronym / sponsor ID
- ACZ ROS 01
- Conditions
- Rosacea
- Keywords
- rosacea, Papulopustular Rosacea,erythema, dapsone
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 400 participants (actual)
- Lead sponsor
- AllerganIndustry (pharma, biotech, devices)
- Study start
- Nov 2005
- Primary completion
- May 2006 (actual)
- Study completion
- May 2006 (actual)
- First posted
- 7 Nov 2005 (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.
The purpose of this study is to evaluate the safety and effectiveness of ACZONE™ gel compared to placebo (inactive substance), MetroGel® and a combination of ACZONE™ gel and MetroGel® for the treatment of rosacea.
ACZONE™ gel, 5% is a topical (applied to the skin) medication that is approved by the United States Food and Drug Administration (FDA) for the treatment of acne vulgaris in people 12 years and older. The use of ACZONE™ for the treatment of rosacea is investigational. An investigational use is one that is not approved by the FDA.
Subjects will apply the study treatment for 12 weeks. Efficacy assessments will be performed at baseline and Weeks 2, 4, 8, and 12. Laboratory assessments will be conducted at baseline and Week, 2, 4 and 12.
Detailed description
Study Objective:
•To evaluate the safety and preliminary efficacy of ACZONE in subjects with papulopustular rosacea
Study Population: Approximately 400 male and female subjects will be enrolled at 27 study centers in the United States.
Study Treatment: Subjects will be randomized to 1 of 5 treatment regimens. Subjects will receive study medication for 12 weeks. Study participation is 13 weeks (5 clinic visits and 1 telephone follow-up).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Men or women ≥18 years of age.
- A diagnosis of papulopustular rosacea, with ≥10 inflammatory lesions (papules and/or pustules) above the mandibular line at baseline.
- An Investigator Global Assessment (IGA) score ≥2
- In good physical and mental health.
- Signature of an approved informed consent form for the study and HIPAA authorization (if applicable).
Key exclusion criteria (9 listed)
- A skin examination reveals the presence of another skin disease and/or condition (excessive facial hair, excessive scarring, sunburn, or other disfigurement) located on the face that would confound the evaluation of the rosacea condition.
- Current or past ocular rosacea, such as conjunctivitis, iritis, and keratitis, of sufficient severity to require topical or systemic antibiotics.
- Treatment with topical antibiotics, topical steroids and other topical rosacea treatments on the face within 14 days of Baseline and throughout the study.
- Treatment with systemic steroids within 30 days of Baseline and throughout the study.
- Treatment with any systemic antibiotics within 30 days of Baseline and throughout the study.
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 |
|---|---|---|
| Vehicle control, 2x/day | Drug | – |
| ACZONE (dapsone) Gel, 5%, 2x/day | Drug | – |
| ACZONE (dapsone) Gel, 5%, 1x/day | Drug | – |
| MetroGel® (metronidazole gel), 1.0% 1x/day | Drug | – |
| ACZONE (dapsone) Gel, 5%, 1x/day (AM) + MetroGel (metronidazole gel), 1.0%, 1x/day (PM) | Drug | – |
Primary outcome
Efficacy: Percent change and change from baseline in inflammatory lesion counts;
"Success" rate, defined as proportion of subjects with a score of 0 or 1 and at least a 2 point improvement from baseline on the IGA scale;
Erythema & telangiectasia scores;
Lesion counts over time
2 secondary outcomes
Safety: Adverse events and concomitant medications; Local symptom scores; Hematology and chemistry laboratory parameters; Vital signs
Other: Plasma dapsone concentrations
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2011.
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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.
Steven Garrett, MS, DDS study director
QLT USA, Inc.
26 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 ACZONE (dapsone) Gel, 5%, 2x/day, ACZONE (dapsone) Gel, 5%, 1x/day and MetroGel® (metronidazole gel), 1.0% 1x/day in people with Rosacea, run by Allergan at 26 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 7 inclusion and 9 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 30 May 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 26 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Efficacy: Percent change and change from baseline in inflammatory lesion counts;. The study lists 4 primary outcomes in all. 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 30 May 2011.