RosaceaPhase 2NCT01993446
A Safety and Efficacy Study of DRM02 in Subjects With Rosacea
A Phase 2 study testing DRM02 in people with Rosacea, run by Dermira, Inc. at 3 sites in Canada.
Trial summary
The purpose of this study is to determine whether DRM02 is safe and effective in the treatment of rosacea when applied twice daily for 6 weeks. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Rosacea
- What is being tested?
- DRM02
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 3 sitesCanada
- Study dates
- Oct 2013to Mar 2014
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female 18 to 70 years of age.
- Clinical diagnosis of rosacea with a score of 2 or 3 on the Investigator's Global Evaluation (IGE) of Rosacea scale and at least 15 and not more than 40 papules.
- Subjects willing to minimize external factors that might trigger rosacea flare-ups.
- Male or non-pregnant, non-lactating females.
- Signed informed consent.
Who cannot join
- Severe self-reported facial sensitivity.
- Severe sun sensitivity.
- Ocular-only, phymatous rosacea or steroid rosacea.
- Use of topical rosacea treatments in the 4 weeks prior to baseline.
- Use of systemic corticosteroids within the 4 weeks prior to baseline.
- Use of systemic antibiotics in the 4 weeks prior to baseline.
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- Use of systemic retinoids for in the 6 months prior to baseline.
- Use of topical retinoids in the 3 months prior to baseline.
- Use of light- or laser-based rosacea treatments in the past 2 months prior to baseline.
- Cosmetic procedures within the 2 months prior to baseline.
- Use of topical anti-aging medications in the 2 weeks prior to baseline.
- Subjects who have poor skin condition within 5 cm of the treatment area.
- Subjects who are current drug or alcohol abusers; have a history of immunodeficiency or are a poor medical risk because of other systemic diseases or active uncontrolled infections.
- Subjects with an unstable medical condition or a medical condition not adequately controlled with standard medical therapy.
- Subjects who are actively participating in an experimental therapy study or who have received experimental therapy within 30 days.
- Subjects who have a clinically significant laboratory value at screening.
Trial locations and contacts
3 sites in 1 country.
Canada3 sites
Clinique Médicale Dr Isabelle Delorme
Drummondville, Quebec, J2B5L4
Innovaderm Research, Inc
Montreal, Quebec, H2K 4L5
Windsor Clinical Research, Inc.
Windsor, Ontario, N8W 5W7
About this study
Official title: A Randomized, Double-blind, Vehicle Controlled Study of the Safety and Efficacy of Topical DRM02 in Subjects With Rosacea
The purpose of this study is to determine whether DRM02 is safe and effective in the treatment of rosacea when applied twice daily for 6 weeks.
Read the detailed description
This is a double-blind, randomized, vehicle controlled, study enrolling 30 subjects with rosacea and designed to assess the safety, tolerability, and preliminary efficacy of DRM02.
Safety will be assessed during the study, through adverse events, local skin responses, urinalysis, serum chemistry and hematology laboratory testing, physical examination and vital signs.
Preliminary efficacy will be assessed through inflammatory lesion counts, the Investigator's Global Evaluation (IGE) and the Rosacea Signs and Symptoms (RSS) scale.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DRM02Drug
VehicleOther
| Study group | Role | What they receive |
|---|---|---|
| DRM02 | Experimental | DRM02 Topical Gel, 0.25% Receives: Drug: DRM02 |
| Vehicle | Placebo comparator | DRM02 Topical Gel, Vehicle Receives: Other: Vehicle |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in inflammatory lesion count
Measured: Week 6
Secondary outcomes (3)
Investigator's Global Evaluation (IGE)
Measured: From baseline to weeks 0, 1, 2, 3, 4 and 6
IGE dichotomized into "success" and "failure"
Measured: Week 6
Percent change in inflammatory lesions
Measured: Week 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2013 (estimated)
- Study startOct 2013
- Primary completionFeb 2014
- Study completionMar 2014
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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dermira, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Beth Zib, Study director, Dermira, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01993446
- Sponsor's protocol ID
- DRM02-ROS02
- Status last verified
- Jul 2021
- First submitted
- 15 Nov 2013
- Last updated
- 20 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Vehicle Controlled Study of the Safety and Efficacy of Topical DRM02 in Subjects With Rosacea
- ClinicalTrials.gov ID
- NCT01993446
- Acronym / sponsor ID
- DRM02-ROS02
- Conditions
- Rosacea
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Dermira, Inc.Industry (pharma, biotech, devices)
- Study start
- Oct 2013
- Primary completion
- Feb 2014 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 25 Nov 2013 (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 determine whether DRM02 is safe and effective in the treatment of rosacea when applied twice daily for 6 weeks.
Detailed description
This is a double-blind, randomized, vehicle controlled, study enrolling 30 subjects with rosacea and designed to assess the safety, tolerability, and preliminary efficacy of DRM02.
Safety will be assessed during the study, through adverse events, local skin responses, urinalysis, serum chemistry and hematology laboratory testing, physical examination and vital signs.
Preliminary efficacy will be assessed through inflammatory lesion counts, the Investigator's Global Evaluation (IGE) and the Rosacea Signs and Symptoms (RSS) scale.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DRM02 | Experimental | Drug: DRM02DRM02 Topical Gel, 0.25% |
| Vehicle | Placebo comparator | Other: VehicleDRM02 Topical Gel, Vehicle |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male or female 18 to 70 years of age.
- Clinical diagnosis of rosacea with a score of 2 or 3 on the Investigator's Global Evaluation (IGE) of Rosacea scale and at least 15 and not more than 40 papules.
- Subjects willing to minimize external factors that might trigger rosacea flare-ups.
- Male or non-pregnant, non-lactating females.
- Signed informed consent.
Key exclusion criteria (16 listed)
- Severe self-reported facial sensitivity.
- Severe sun sensitivity.
- Ocular-only, phymatous rosacea or steroid rosacea.
- Use of topical rosacea treatments in the 4 weeks prior to baseline.
- Use of systemic corticosteroids within the 4 weeks prior to baseline.
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 |
|---|---|---|
| DRM02 | Drug | DRM02 |
| Vehicle | Other | Vehicle |
Primary outcome
Change in inflammatory lesion count
Time frame: Week 6
3 secondary outcomes
Investigator's Global Evaluation (IGE)
Time frame: From baseline to weeks 0, 1, 2, 3, 4 and 6
IGE dichotomized into "success" and "failure"
Time frame: Week 6
Percent change in inflammatory lesions
Time frame: Week 6
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 20 Jul 2021.
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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.
Beth Zib study director
Dermira, Inc.
3 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 DRM02 in people with Rosacea, run by Dermira, Inc. at 3 sites in Canada.
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 5 inclusion and 16 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 20 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in 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 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?
Change in inflammatory lesion count (time frame: Week 6). 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 20 Jul 2021.