Papulopustular RosaceaPhase 3NCT01494467
Phase 3 Papulopustular Rosacea Study
A Phase 3 study testing CD5024 and Azelaic acid 15% Gel in people with Papulopustular Rosacea, run by Galderma R&D at 50 sites in 2 countries.
Trial summary
The purpose of this study is to demonstrate that CD5024 1% cream is more effective than its vehicle when applied once daily, at bed time, during a 12 week period in subjects with Papulopustular Rosacea (PPR) and continues to be safe up to 12 months. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Papulopustular Rosacea
- What is being tested?
- CD5024 and Azelaic acid 15% Gel
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 688 participants
- Where
- 50 sitesin 2 countries
- Study dates
- Dec 2011to Aug 2013
- Phase
- Phase 3
- 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
- The subject has papulopustular rosacea with an Investigator Global Assessment (IGA) score rated 3 (moderate) or 4 (severe),
- The subject has at least 15 but not more than 70 inflammatory lesions (papules and pustules) on the face.
Who cannot join
- The subject has particular forms of rosacea (rosacea conglobata, rosacea fulminans, isolated rhinophyma, isolated pustulosis of the chin) or other facial dermatoses that may be confounded with papulopustular rosacea, such as peri oral dermatitis, facial keratosis pilaris, seborrheic dermatitis, and acne,
- The subject has rosacea with more than two nodules on the face.
Trial locations and contacts
50 sites in 2 countries.
50 sites in 2 countries
United States40 sites
Academic Dermatology Associates
Albuquerque, New Mexico, 87106
Atlanta Dermatology, Vein & Research Center, LLC
Alpharetta, Georgia, 30022
David Fivenson, MD, PLC
Ann Arbor, Michigan, 48103
Arlington Research Center, Inc
Arlington, Texas, 76011
Altman Dermatology Associates
Arlington Heights, Illinois, 60005
Emory University
Atlanta, Georgia, 30322
Northeast Dermatology Associates
Beverly, Massachusetts, 01915
Total Skin and Beauty
Birmingham, Alabama, 35205
Northwestern University
Chicago, Illinois, 60611
Deaconess Clinic, Inc.
Evansville, Indiana, 47713
Dermatology and Skin Surgery Center
Exton, Pennsylvania, 19341
Hamzavi Dermatology
Fort Gratiot, Michigan, 48059
Philadelphia Institute of Dermatology
Fort Washington, Pennsylvania, 19034
Penn State Hershey Medical Center
Hershey, Pennsylvania, 17033
Study site
High Point, North Carolina, 27262
Burke Pharmaceutical Research
Hot Springs, Arkansas, 71913
Dawes Fretzin Clinical Research Group, LLC
Indianapolis, Indiana, 46256
The Skin Wellness Center
Knoxville, Tennessee, 37922
Dermatology Specialists Research
Louisville, Kentucky, 40202
FXM Research Corp Miami
Miami, Florida, 33175
Coastal Clinical Research, Inc.
Mobile, Alabama, 36608
Dermatology Reserach Associates
Nashville, Tennessee, 17203
Dermatology Specialists, Inc
Oceanside, California, 92056
Leavitt Medical Associates of Florida dba Ameriderm Research
Ormond Beach, Florida
Paddington Research
Philadelphia, Pennsylvania, 19103
Oregon Dermatology and Research Center
Portland, Oregon, 97210
PMG Research of Raleigh, LLC
Raleigh, North Carolina, 27609
Integrated Research Group, Inc
Riverside, California, 92506
Stephen Miller MD
San Antonio, Texas, 78229
Study site
San Antonio, Texas, 78229
Therapeutics Clinical Research
San Diego, California, 92123
University of California, San Francisco
San Francisco, California, 94143
ATS Clinical Research
Santa Monica, California, 90404
Redwood Dermatology Research
Santa Rosa, California, 95403
Dermatology Clinical Trials Unit
St Louis, Missouri, 63141
DermResearch Center of New York, Inc
Stony Brook, New York, 11790
Somerset Skin Centre
Troy, Michigan, 48084
Center for Clinical Studies
Webster, Texas, 77598
Psoriasis Treatment Center of NJ
West Windsor, New Jersey
Yardley Dermatology Associates
Yardley, Pennsylvania, 19067
Canada10 sites
Ultranova Skincare
Barrie, Ontario, L4M 6L2
Dermatrials Research
Hamilton, Ontario, L8N 1V6
The Guenther Dermatology Research Center
London, Ontario, N6A 3H7
Lynderm Research Inc
Markham, Ontario, L3P 1A8
International Dermatology Research, Inc
Montreal, Quebec, H3H 1V4
North Bay Dermatology Centre, Inc
North Bay, Ontario, P1B 3Z7
Centre de Recherche Dermatologique du Quebec Metropolitan
Québec, Quebec, G1V 4X7
The Centre for Dermatology & Cosmetic Surgery
Richmond Hill, Ontario, L4B 1A5
Guildford Dermatology Specialists
Surrey, British Columbia, V3R 6A7
XLR8 Medical Research, Inc
Windsor, Ontario, N8W 1E6
About this study
Official title: A Phase 3 Randomized, Double Blind, 12 Week Vehicle Controlled, Parallel Group Study Assessing the Efficacy and Safety of CD5024 1 % Cream Versus Vehicle Cream in Subjects With Papulopustular Rosacea, Followed by a 40 Week Investigator Blinded Extension Comparing the Long Term Safety of CD5024 1% Cream Versus Azelaic Acid 15 % Gel.
The purpose of this study is to demonstrate that CD5024 1% cream is more effective than its vehicle when applied once daily, at bed time, during a 12 week period in subjects with Papulopustular Rosacea (PPR) and continues to be safe up to 12 months.
- Conditions
- Papulopustular Rosacea
- Being tested
- CD5024, Azelaic acid 15% Gel
- Keywords
- PPR
- Medical subject headings
- Rosacea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CD5024Drug
CD5024 1% Cream, once daily
Azelaic acid 15% GelDrug
Topical Gel applied twice daily
| Study group | Role | What they receive |
|---|---|---|
| CD5024 | Experimental | CD5024 1% Cream Receives: Drug: CD5024 |
| CD5024 Vehicle | Placebo comparator | CD5024 Vehicle Cream Receives: Drug: Azelaic acid 15% Gel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Success Rate
Percentage of subjects who achieve "Clear" (Score 0) or "Almost Clear" (Score 1) at Week 12 (ITT-LOCF) based on the Investigator Global Assessment (IGA) Score.
Evaluation of papulopustular rosacea will be performed by the investigator based on the following 5 point scale:
Clear = 0 (No inflammatory lesions present, no erythema); Almost Clear = 1 (Very few small papules/pustules, very mild erythema present); Mild = 2 (Few small papules/pustules, mild erythema); Moderate = 3 (Several small or large papules/pustules, moderate erythema); Severe = 4 (Numerous small and/or large papules/pustules, severe erythema)
Measured: Week 12
Absolute Change in Inflammatory Lesion Count
Inflammatory lesion counts were conducted at each visit by the Investigator or study coordinator. Papules and pustules were counted separately on each of the five facial regions (forehead, chin, nose, right cheek, left cheek).
Measured: Baseline to Week 12
Secondary outcomes (1)
Percent Change in Inflammatory Lesion Count From Baseline to Week 12 (ITT-LOCF)
Inflammatory lesion counts were conducted at each visit by the Investigator or study coordinator. Papules and pustules were counted separately on each of the five facial regions (forehead, chin, nose, right cheek, left cheek).
Measured: Baseline to Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2011 (estimated)
- Study startDec 2011
- Primary completionAug 2013
- Study completionAug 2013
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 Papulopustular 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 688 participants (actual)
Sponsor and investigators
- Lead sponsor
- Galderma R&D
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Michael Graeber, M.D., Study director, Galderma R&D, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01494467
- Sponsor's protocol ID
- RD.06.SPR.18171
- Status last verified
- Jan 2015
- First submitted
- 14 Dec 2011
- Last updated
- 18 Feb 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3 Randomized, Double Blind, 12 Week Vehicle Controlled, Parallel Group Study Assessing the Efficacy and Safety of CD5024 1 % Cream Versus Vehicle Cream in Subjects With Papulopustular Rosacea, Followed by a 40 Week Investigator Blinded Extension Comparing the Long Term Safety of CD5024 1% Cream Versus Azelaic Acid 15 % Gel.
- ClinicalTrials.gov ID
- NCT01494467
- Acronym / sponsor ID
- RD.06.SPR.18171
- Conditions
- Papulopustular Rosacea
- Keywords
- PPR
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 688 participants (actual)
- Lead sponsor
- Galderma R&DIndustry (pharma, biotech, devices)
- Study start
- Dec 2011
- Primary completion
- Aug 2013 (actual)
- Study completion
- Aug 2013 (actual)
- First posted
- 19 Dec 2011 (estimated)
- Results
- Posted 16 Jan 2015
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 demonstrate that CD5024 1% cream is more effective than its vehicle when applied once daily, at bed time, during a 12 week period in subjects with Papulopustular Rosacea (PPR) and continues to be safe up to 12 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CD5024 | Experimental | Drug: CD5024CD5024 1% Cream |
| CD5024 Vehicle | Placebo comparator | Drug: Azelaic acid 15% GelCD5024 Vehicle Cream |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- The subject has papulopustular rosacea with an Investigator Global Assessment (IGA) score rated 3 (moderate) or 4 (severe),
- The subject has at least 15 but not more than 70 inflammatory lesions (papules and pustules) on the face.
Key exclusion criteria (2 listed)
- The subject has particular forms of rosacea (rosacea conglobata, rosacea fulminans, isolated rhinophyma, isolated pustulosis of the chin) or other facial dermatoses that may be confounded with papulopustular rosacea, such as peri oral dermatitis, facial keratosis pilaris, seborrheic dermatitis, and acne,
- The subject has rosacea with more than two nodules on the face.
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 |
|---|---|---|
| CD5024CD5024 1% Cream, once daily | Drug | CD5024 |
| Azelaic acid 15% GelTopical Gel applied twice daily | Drug | CD5024 Vehicle |
Primary outcome
Success Rate
Time frame: Week 12
Percentage of subjects who achieve "Clear" (Score 0) or "Almost Clear" (Score 1) at Week 12 (ITT-LOCF) based on the Investigator Global Assessment (IGA) Score. Evaluation of papulopustular rosacea will be performed by the investigator based on the following 5 point scale: Clear = 0 (No inflammatory lesions present, no erythema); Almost Clear = 1 (Very few small papules/pustules, very mild erythema present); Mild = 2 (Few small papules/pustules, mild erythema); Moderate = 3 (Several small or large papules/pustules, moderate erythema); Severe = 4 (Numerous small and/or large papules/pustules, severe erythema)
Absolute Change in Inflammatory Lesion Count
Time frame: Baseline to Week 12
Inflammatory lesion counts were conducted at each visit by the Investigator or study coordinator. Papules and pustules were counted separately on each of the five facial regions (forehead, chin, nose, right cheek, left cheek).
1 secondary outcome
Percent Change in Inflammatory Lesion Count From Baseline to Week 12 (ITT-LOCF)
Time frame: Baseline to Week 12
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Michael Graeber, M.D. study director
Galderma R&D, LLC
50 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing CD5024 and Azelaic acid 15% Gel in people with Papulopustular Rosacea, run by Galderma R&D at 50 sites in 2 countries.
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 2 inclusion and 2 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 18 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 50 sites in United States, Canada. 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. Some participants in this study may receive a placebo. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 16 Jan 2015). 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?
Success Rate (time frame: Week 12). The study lists 2 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 18 Feb 2021.