Acne RosaceaPhase 2NCT03003104
DMT210 Topical Gel in the Treatment of Acne Rosacea
A Phase 2 study testing DMT210 Topical Gel 5% in people with Acne Rosacea, run by Dermata Therapeutics at 9 sites in United States.
Trial summary
The study evaluates the safety, tolerability, and efficacy of DMT210 Gel, 5% when applied twice daily for 12 weeks in adult patients with moderate to severe acne rosacea. Half of participants will receive DMT210 Gel while the other half will receive vehicle control. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acne Rosacea
- What is being tested?
- DMT210 Topical Gel 5%
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 107 participants
- Where
- 9 sitesUnited States
- Study dates
- Jan 2017to 30 Aug 2017
- 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
- Patient is male or non-pregnant female at least 18 years of age.
- Clinical diagnosis of moderate to severe facial rosacea as determined by Investigator's Global Assessment (IGA) at Randomization
- Patient has at least ten inflammatory lesions of rosacea on the face at Randomization
- Patient is willing to apply the Investigational Product as directed
- Patient is willing and able to comply with the protocol
Who cannot join
- Patient is pregnant or planning to become pregnant
- Patient is taking a topical therapy which may affect the patient's rosacea
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
United States9 sites
Dermata Investigational Site
Austin, Texas
Dermata Investigational Site
Broomall, Pennsylvania
Dermata Investigational Site
Fridley, Minnesota
Dermata Investigational Site
High Point, North Carolina
Dermata Investigational Site
Miami, Florida
Dermata Investigational Site
Nashville, Tennessee
Dermata Investigational Site
Norfolk, Virginia
Dermata Investigational Site
Omaha, Nebraska
Dermata Investigational Site
San Diego, California
About this study
Official title: A Randomized, Double-Blind, Vehicle Controlled Study To Evaluate The Safety, Tolerability, And Efficacy Of DMT210 Gel In Adult Patients With Moderate To Severe Acne Rosacea
The study evaluates the safety, tolerability, and efficacy of DMT210 Gel, 5% when applied twice daily for 12 weeks in adult patients with moderate to severe acne rosacea. Half of participants will receive DMT210 Gel while the other half will receive vehicle control.
- Conditions
- Acne Rosacea
- Being tested
- DMT210 Topical Gel 5%, Vehicle Control
- Keywords
- Skin diseases, rosacea
- Medical subject headings
- Rosacea, Skin Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DMT210 Topical Gel 5%Drug
Vehicle ControlOther
| Study group | Role | What they receive |
|---|---|---|
| DMT210 Topical Gel | Experimental | DMT210 Topical Gel 5% applied to the face twice daily for 12 weeks Receives: Drug: DMT210 Topical Gel 5% |
| Vehicle Control | Placebo comparator | Topical Gel vehicle applied to the face twice daily for 12 weeks Receives: Other: Vehicle Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy as measured by Inflammatory lesion counts
Inflammatory lesion counts
Measured: 12 weeks
Efficacy as measured by Investigator Global Assessment (IGA)
Investigator Global Assessment (IGA)
Measured: 12 weeks
Efficacy as measured by 5-point Clinical Erythema Assessment (CEA)
5-point Clinical Erythema Assessment (CEA)
Measured: 12 weeks
Efficacy as measured by 5-point Patient Severity Assessment of Erythema (PSA)
5-point Patient Severity Assessment of Erythema (PSA)
Measured: 12 weeks
Secondary outcomes (1)
Incidence of adverse events as a measure of safety and tolerability
Incidence of adverse events as a measure of safety and tolerability
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Dec 2016 (estimated)
- Study startJan 2017
- Primary completion30 Aug 2017
- Study completion30 Aug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acne 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
- 107 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dermata Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03003104
- Sponsor's protocol ID
- DMT210-003
- Status last verified
- Apr 2018
- First submitted
- 20 Dec 2016
- Last updated
- 18 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Vehicle Controlled Study To Evaluate The Safety, Tolerability, And Efficacy Of DMT210 Gel In Adult Patients With Moderate To Severe Acne Rosacea
- ClinicalTrials.gov ID
- NCT03003104
- Acronym / sponsor ID
- DMT210-003
- Conditions
- Acne Rosacea
- Keywords
- Skin diseases, rosacea
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 107 participants (actual)
- Lead sponsor
- Dermata TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- Jan 2017
- Primary completion
- 30 Aug 2017 (actual)
- Study completion
- 30 Aug 2017 (actual)
- First posted
- 26 Dec 2016 (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 study evaluates the safety, tolerability, and efficacy of DMT210 Gel, 5% when applied twice daily for 12 weeks in adult patients with moderate to severe acne rosacea. Half of participants will receive DMT210 Gel while the other half will receive vehicle control.
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 |
|---|---|---|
| DMT210 Topical Gel | Experimental | Drug: DMT210 Topical Gel 5%DMT210 Topical Gel 5% applied to the face twice daily for 12 weeks |
| Vehicle Control | Placebo comparator | Other: Vehicle ControlTopical Gel vehicle applied to the face twice daily for 12 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patient is male or non-pregnant female at least 18 years of age.
- Clinical diagnosis of moderate to severe facial rosacea as determined by Investigator's Global Assessment (IGA) at Randomization
- Patient has at least ten inflammatory lesions of rosacea on the face at Randomization
- Patient is willing to apply the Investigational Product as directed
- Patient is willing and able to comply with the protocol
Key exclusion criteria (2 listed)
- Patient is pregnant or planning to become pregnant
- Patient is taking a topical therapy which may affect the patient's rosacea
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 |
|---|---|---|
| DMT210 Topical Gel 5% | Drug | DMT210 Topical Gel |
| Vehicle Control | Other | Vehicle Control |
Primary outcome
Efficacy as measured by Inflammatory lesion counts
Time frame: 12 weeks
Inflammatory lesion counts
Efficacy as measured by Investigator Global Assessment (IGA)
Time frame: 12 weeks
Investigator Global Assessment (IGA)
Efficacy as measured by 5-point Clinical Erythema Assessment (CEA)
Time frame: 12 weeks
5-point Clinical Erythema Assessment (CEA)
Efficacy as measured by 5-point Patient Severity Assessment of Erythema (PSA)
Time frame: 12 weeks
5-point Patient Severity Assessment of Erythema (PSA)
1 secondary outcome
Incidence of adverse events as a measure of safety and tolerability
Time frame: 12 weeks
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 18 Apr 2018.
- Individual participant dataSharing planned: No
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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.
9 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 DMT210 Topical Gel 5% in people with Acne Rosacea, run by Dermata Therapeutics at 9 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 5 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 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 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. 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?
Efficacy as measured by Inflammatory lesion counts (time frame: 12 weeks). 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 18 Apr 2018.