Papulopustular RosaceaPhase 3ATTRACTNCT01493947
CD5024 1% [Ivermectin 1%] Cream Versus Metronidazole 0.75% Cream in Papulopustular Rosacea (PPR) Study
A Phase 3 study testing Ivermectin 1% cream and Metronidazole 0.75% cream in people with Papulopustular Rosacea, run by Galderma R&D at 60 sites in 10 countries.
Trial summary
Study objectives: To compare efficacy and safety of Ivermectin 1% cream versus metronidazole 0.75% cream in subjects with papulopustular rosacea after 16-week topical treatment. And to compare, for subjects initially successfully treated by 16 weeks treatment, Ivermectin 1 % cream versus metronidazole 0.75% cream… 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?
- Ivermectin 1% cream and Metronidazole 0.75% cream
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 962 participants
- Where
- 60 sitesin 10 countries
- Study dates
- Apr 2012to Dec 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
- Subjects with papulopustular rosacea scored 3 (moderate) or 4 (severe) according to the Investigator Global Assessment (IGA),
- Subjects with at least 15 but not more than 70 inflammatory lesions (papules and pustules) on the face.
Who cannot join
- Subjects with particular forms of rosacea (rosacea conglobate, rosacea fulminant, 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 pilar, or seborrheic dermatitis and acne,
- Subjects with rosacea with more than two nodules on the face.
Trial locations and contacts
60 sites in 10 countries.
60 sites in 10 countries
Germany13 sites
Galderma Investigational Site
Augsburg
Galderma Investigational Site
Berlin, 13 507
Galderma Investigational Site
Bonn
Galderma Investigational Site
Darmstadt, 64 297
Galderma Investigational Site
Dresden
Galderma Investigational Site
Hamburg
Galderma Investigational Site
Langenau, 89 129
Galderma Investigational Site
Mahlow, 15 831
Galderma Investigational Site
Mainz
Galderma Investigational Site
Munich
Galderma Investigational Site
Münster
Galderma Investigational Site
Tübingen
Galderma Investigational Site
Wuppertal
Hungary10 sites
Galderma Investigational Site
Budapest, 052
Galderma Investigational Site
Budapest, 1135
Galderma Investigational Site
Budapest, 1238
Galderma Investigational Site
Budapest
Galderma Investigational Site
Debrecen, 4032
Galderma Investigational Site
Miskolc
Galderma Investigational Site
Pécel, 21 19
Galderma Investigational Site
Szeged
Galderma Investigational Site
Szekszárd
Galderma Investigational Site
Szolnok
Czechia6 sites
Galderma Investigational Site
Chomutov
Galderma Investigational Site
Hradec Králové
Galderma Invetigational site
Olomouc
Galderma Investigational Site
Pardubice
Galderma Investigational Site
Prague, 110 00
Galderma Investigational Site
Slaný, 27 401
France5 sites
Galderma Investigational Site
Bordeaux
Galderma Investigational Site
Brest
Galderma Investigational Site
Cannes
Galderma Investigational Site
Nice
Galderma Investigational Site
Saint-Etienne
Poland5 sites
Galderma Investigational Site
Bialystok
Galderma Investigational Site
Gdansk
Galderma Investigational Site
Krakow
Galderma Investigational Site
Warsaw
Galderma Investigational Site
Wroclaw
Romania5 sites
Galderma Investigational Site
Brasov
Galderma Investigational Site
Bucharest
Galderma Investigational Site
Craiova
Galderma Investigational Site
Târgu Mureş
Galderma Investigational Site
Timișoara
Ukraine5 sites
Galderma Investigational Site
Dnipropetrovsk
Galderma Investigational Site
Donetsk
Galderma Investigational Site
Kiev
Galderma Investigational Site
Lviv
Galderma Investigational Site
Uzhhorod
Russia4 sites
Galderma Investigational Site
Chelyabinsk
Galderma Investigational Site
Lipetsk
Galderma Investigational Site
Moscow
Galderma Investigational Site
Nizhny Novgorod
United Kingdom4 sites
Galderma Investigational Site
Berkshire
Galderma Investigational Site
Bexhill-on-Sea
Galderma Investigational Site
London
Galderma Investigational Site
Nuneaton
Bulgaria3 sites
Galderma Investigational Site
Pleven
Galderma Investigational Site
Plovdiv
Galderma Investigational Site
Sofia
About this study
Official title: Efficacy and Safety of CD5024 1% Cream Versus Metronidazole 0.75% Cream in Subjects With Papulopustular Rosacea Over 16 Weeks Treatment, Followed by a 36-week Extension Period.
Study objectives:
- To compare efficacy and safety of Ivermectin 1% cream versus metronidazole 0.75% cream in subjects with papulopustular rosacea after 16-week topical treatment.
- And to compare, for subjects initially successfully treated by 16 weeks treatment, Ivermectin 1 % cream versus metronidazole 0.75% cream during a 36-week extension period by assessing, the time of first relapse, the relapse rate, and the number of days free of treatment
- Conditions
- Papulopustular Rosacea
- Being tested
- Ivermectin 1% cream, Metronidazole 0.75% cream
- Medical subject headings
- Rosacea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ivermectin 1% creamDrug
Also called Soolantra
Ivermectin 1% cream applied once daily on the face during 16-week plus 36-week extension period.
Metronidazole 0.75% creamDrug
Also called Metronidazole
Metronidazole 0.75% cream applied twice daily on the face during 16-week plus 36-week extension period.
| Study group | Role | What they receive |
|---|---|---|
| Ivermectin 1% cream | Experimental | Not described Receives: Drug: Ivermectin 1% cream |
| Metronidazole 0.75% cream | Active comparator | Not described Receives: Drug: Metronidazole 0.75% cream |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent Change in Inflammatory Lesions From Baseline to Week 16
Efficacy of Ivermectin versus Metronidazole as determined by the percent change in inflammatory lesions after a 16-week treatment period
Measured: Baseline and Week 16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2011 (estimated)
- Study startApr 2012
- Primary completionDec 2013
- Study completionDec 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.
- More trials run by Galderma R&DThe sponsor's other registered studies.
- 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
- Single blind
- Who is masked
- Investigator
- Enrolment
- 962 participants (actual)
Sponsor and investigators
- Lead sponsor
- Galderma R&D
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01493947
- Sponsor's protocol ID
- RD.03.SPR.40173
- Acronym
- ATTRACT
- Status last verified
- Sep 2015
- First submitted
- 15 Dec 2011
- Last updated
- 28 Oct 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of CD5024 1% Cream Versus Metronidazole 0.75% Cream in Subjects With Papulopustular Rosacea Over 16 Weeks Treatment, Followed by a 36-week Extension Period.
- ClinicalTrials.gov ID
- NCT01493947
- Acronym / sponsor ID
- ATTRACT / RD.03.SPR.40173
- Conditions
- Papulopustular Rosacea
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 962 participants (actual)
- Lead sponsor
- Galderma R&DIndustry (pharma, biotech, devices)
- Study start
- Apr 2012
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 16 Dec 2011 (estimated)
- Results
- Posted 28 Oct 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Study objectives:
- To compare efficacy and safety of Ivermectin 1% cream versus metronidazole 0.75% cream in subjects with papulopustular rosacea after 16-week topical treatment.
- And to compare, for subjects initially successfully treated by 16 weeks treatment, Ivermectin 1 % cream versus metronidazole 0.75% cream during a 36-week extension period by assessing, the time of first relapse, the relapse rate, and the number of days free of treatment
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ivermectin 1% cream | Experimental | Drug: Ivermectin 1% cream |
| Metronidazole 0.75% cream | Active comparator | Drug: Metronidazole 0.75% 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)
- Subjects with papulopustular rosacea scored 3 (moderate) or 4 (severe) according to the Investigator Global Assessment (IGA),
- Subjects with at least 15 but not more than 70 inflammatory lesions (papules and pustules) on the face.
Key exclusion criteria (2 listed)
- Subjects with particular forms of rosacea (rosacea conglobate, rosacea fulminant, 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 pilar, or seborrheic dermatitis and acne,
- Subjects with 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 |
|---|---|---|
| Ivermectin 1% creamAlso: SoolantraIvermectin 1% cream applied once daily on the face during 16-week plus 36-week extension period. | Drug | Ivermectin 1% cream |
| Metronidazole 0.75% creamAlso: MetronidazoleMetronidazole 0.75% cream applied twice daily on the face during 16-week plus 36-week extension period. | Drug | Metronidazole 0.75% cream |
Primary outcome
Percent Change in Inflammatory Lesions From Baseline to Week 16
Time frame: Baseline and Week 16
Efficacy of Ivermectin versus Metronidazole as determined by the percent change in inflammatory lesions after a 16-week treatment period
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2015.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
60 sites in 10 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Ivermectin 1% cream and Metronidazole 0.75% cream in people with Papulopustular Rosacea, run by Galderma R&D at 60 sites in 10 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 28 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 60 sites in Germany, Hungary, Czechia, France, Poland and 5 more countries. 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 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 28 Oct 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?
Percent Change in Inflammatory Lesions From Baseline to Week 16 (time frame: Baseline and Week 16). 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 28 Oct 2015.