PsoriasisPhase 2NCT01993433
A Safety and Efficacy Study of DRM02 in Subjects With Plaque Psoriasis
A Phase 2 study testing DRM02 in people with Psoriasis, run by Dermira, Inc. at 2 sites in Canada.
Trial summary
The purpose of this study is to determine whether DRM02 is safe and effective in the treatment of plaque psoriasis 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
- Psoriasis
- What is being tested?
- DRM02
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 23 participants
- Where
- 2 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.
- Plaque-type psoriasis with two lesions of similar size and have an identical score of at least 6 but no more than 8 on the sum of the individual components of the Severity of Psoriasis Area Severity Index (PASI) at the Target Lesion scale.
- Male or non-pregnant, non-lactating females.
- Signed informed consent.
Who cannot join
- Subjects who have extensive, and/or 'inverse', and/or exfoliative psoriasis.
- Subjects who have taken any systemic treatment for psoriasis within the 4 weeks prior to baseline.
- Prior or concomitant use of topical treatments for psoriasis to within 10 cm of the target lesion within the 4 weeks prior to baseline.
- Use of Enbrel within the 4 weeks prior to baseline.
- Psoralen \& ultraviolet A therapy (PUVA) or the use of ultraviolet B (UVB) therapy and/or excessive or prolonged exposure to ultraviolet light within the 4 weeks prior to baseline.
- Use of Humira or Remicade within the 3 months prior to baseline.
Show all 13Show fewer
- Use of Stelara within the 6 months prior to baseline.
- Subjects who have taken oral retinoids for psoriasis within the 6 months prior to baseline.
- Subjects who have poor skin condition within 5 cm of the target lesion.
- Subjects who are current drug or alcohol abusers; have a history of immunodeficiency disease 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
2 sites in 1 country.
Canada2 sites
Clinique Médicale Dr Isabelle Delorme
Drummondville, Quebec, J2B5L4
Innovaderm Research, Inc
Montreal, Quebec, H2K 4L5
About this study
Official title: A Randomized, Double-blind, Vehicle Controlled Study of the Safety and Efficacy of Topical DRM02 in Subjects With Plaque Psoriasis
The purpose of this study is to determine whether DRM02 is safe and effective in the treatment of plaque psoriasis when applied twice daily for 6 weeks.
Read the detailed description
This is a double-blind, randomized, within-subject control, study enrolling 20 subjects with plaque psoriasis 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 the Physician's Lesion Assessment (PLA) and the Severity of Psoriasis Area Severity Index (PASI) from only the two plaques identified at the baseline visit.
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 Physician's Lesion Assessment
Measured: Week 6
Secondary outcomes (2)
Physician's Lesion Assessment
Measured: From baseline to weeks 0, 1, 2, 3, 4 and 6
PLA dichotomized into "success" and "failure"
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 PsoriasisStudies 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
- 23 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
- NCT01993433
- Sponsor's protocol ID
- DRM02-PSO02
- 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 Plaque Psoriasis
- ClinicalTrials.gov ID
- NCT01993433
- Acronym / sponsor ID
- DRM02-PSO02
- Conditions
- Psoriasis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 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 plaque psoriasis when applied twice daily for 6 weeks.
Detailed description
This is a double-blind, randomized, within-subject control, study enrolling 20 subjects with plaque psoriasis 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 the Physician's Lesion Assessment (PLA) and the Severity of Psoriasis Area Severity Index (PASI) from only the two plaques identified at the baseline visit.
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 (4 listed)
- Male or female 18 to 70 years of age.
- Plaque-type psoriasis with two lesions of similar size and have an identical score of at least 6 but no more than 8 on the sum of the individual components of the Severity of Psoriasis Area Severity Index (PASI) at the Target Lesion scale.
- Male or non-pregnant, non-lactating females.
- Signed informed consent.
Key exclusion criteria (13 listed)
- Subjects who have extensive, and/or 'inverse', and/or exfoliative psoriasis.
- Subjects who have taken any systemic treatment for psoriasis within the 4 weeks prior to baseline.
- Prior or concomitant use of topical treatments for psoriasis to within 10 cm of the target lesion within the 4 weeks prior to baseline.
- Use of Enbrel within the 4 weeks prior to baseline.
- Psoralen \& ultraviolet A therapy (PUVA) or the use of ultraviolet B (UVB) therapy and/or excessive or prolonged exposure to ultraviolet light 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 Physician's Lesion Assessment
Time frame: Week 6
2 secondary outcomes
Physician's Lesion Assessment
Time frame: From baseline to weeks 0, 1, 2, 3, 4 and 6
PLA dichotomized into "success" and "failure"
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.
2 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 Psoriasis, run by Dermira, Inc. at 2 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 4 inclusion and 13 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 2 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 Physician's Lesion Assessment (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.