Acne RosaceaPhase 2NCT05108025
DMT310-005 Topical in the Treatment of Acne Rosacea
A Phase 2 study testing Topical Powder in people with Acne Rosacea, run by Dermata Therapeutics at 1 site in United States.
Trial summary
The objective is to evaluate the tolerability, safety, and efficacy of DMT310 topical powder mixed with diluent in male and female patients with moderate to severe facial acne rosacea. 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?
- Topical Powder
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 180 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Nov 2021to Dec 2022
- 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 papulopustular acne rosacea as determined by:
- Investigator's Global Assessment (IGA) at Randomization score of 3 or 4. Patient has at least 15 inflammatory lesions on the face
- 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 on the face which may affect the patient's rosacea
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Study Of The Tolerability, Safety, And Efficacy Of DMT310 For The Treatment Of Acne Rosacea
The objective is to evaluate the tolerability, safety, and efficacy of DMT310 topical powder mixed with diluent in male and female patients with moderate to severe facial acne rosacea.
- Conditions
- Acne Rosacea
- Being tested
- Topical Powder, Placebo Topical Powder
- Medical subject headings
- Rosacea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Topical PowderDrug
Topical Powder mixed with diluent
Placebo Topical PowderDrug
Placebo Topical Powder mixed with diluent
| Study group | Role | What they receive |
|---|---|---|
| Study Treatment 1 | Experimental | DMT310 Powder mixed with Hydrogen Peroxide Receives: Drug: Topical Powder |
| Study Treatment 2 | Experimental | Placebo powder mixed with Hydrogen Peroxide Receives: Drug: Placebo Topical Powder |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy as measured by lesion counts
Inflammatory lesion counts
Measured: 12 Weeks
Efficacy as measured by Investigator Global Assessment (IGA)
IGA Scale:
0 Clear No papules and/or pustules
- Almost Clear Rare papules and/or pustules
- Mild Few papules and/or pustules
- Moderate Pronounced number of papules and/or pustules (but less than numerous papules and/or pustules)
- Severe Numerous papules and/or pustules, occasionally with confluent areas of inflamed lesions
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 posted4 Nov 2021
- Study start15 Nov 2021
- Primary completionDec 2022 (estimated)
- Study completionDec 2022 (estimated)
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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 180 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
- NCT05108025
- Sponsor's protocol ID
- DMT310-005
- Status last verified
- Dec 2022
- First submitted
- 26 Oct 2021
- Last updated
- 8 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study Of The Tolerability, Safety, And Efficacy Of DMT310 For The Treatment Of Acne Rosacea
- ClinicalTrials.gov ID
- NCT05108025
- Acronym / sponsor ID
- DMT310-005
- Conditions
- Acne Rosacea
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 180 participants (actual)
- Lead sponsor
- Dermata TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- 15 Nov 2021 (actual)
- Primary completion
- Dec 2022 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 4 Nov 2021 (actual)
- 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 objective is to evaluate the tolerability, safety, and efficacy of DMT310 topical powder mixed with diluent in male and female patients with moderate to severe facial acne rosacea.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study Treatment 1 | Experimental | Drug: Topical PowderDMT310 Powder mixed with Hydrogen Peroxide |
| Study Treatment 2 | Experimental | Drug: Placebo Topical PowderPlacebo powder mixed with Hydrogen Peroxide |
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.
- Investigator's Global Assessment (IGA) at Randomization score of 3 or 4. Patient has at least 15 inflammatory lesions on the face
- Patient is willing to apply the Investigational Product as directed
- Patient is willing and able to comply with the protocol
Key exclusion criteria (1 listed)
- Patient is pregnant or planning to become pregnant Patient is taking a topical therapy on the face 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 |
|---|---|---|
| Topical PowderTopical Powder mixed with diluent | Drug | Study Treatment 1 |
| Placebo Topical PowderPlacebo Topical Powder mixed with diluent | Drug | Study Treatment 2 |
Primary outcome
Efficacy as measured by lesion counts
Time frame: 12 Weeks
Inflammatory lesion counts
Efficacy as measured by Investigator Global Assessment (IGA)
Time frame: 12 Weeks
IGA Scale: 0 Clear No papules and/or pustules 1. Almost Clear Rare papules and/or pustules 2. Mild Few papules and/or pustules 3. Moderate Pronounced number of papules and/or pustules (but less than numerous papules and/or pustules) 4. Severe Numerous papules and/or pustules, occasionally with confluent areas of inflamed lesions
1 secondary outcome
Incidence of adverse events as a measure of safety and tolerability
Time frame: 12 Weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2022.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Topical Powder in people with Acne Rosacea, run by Dermata Therapeutics at 1 site 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 1 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: status not confirmed, as of the sponsor's last update on 8 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. 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?
Results are not available in the source record.
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 lesion counts (time frame: 12 Weeks). 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 8 Dec 2022.