Acne VulgarisPhase 2NCT03536637
DMT310-001 Topical in the Treatment of Acne Vulgaris
A Phase 2 study testing DMT310 and Hydrogen Peroxide in people with Acne Vulgaris, run by Dermata Therapeutics at 9 sites 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 vulgaris. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Acne Vulgaris
- What is being tested?
- DMT310 and Hydrogen Peroxide
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 121 participants
- Where
- 9 sitesUnited States
- Study dates
- 22 May 2018to 28 Jan 2019
- 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 12 years and older
- All sexes
- No healthy volunteers
- Child, 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 acne vulgaris as determined by:
- Investigator's Global Assessment (IGA) at Randomization Patient has at least 20 but not more than 50 inflammatory lesions on the face Patient has at least 20 but not more than 100 noninflammatory 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 acne
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
United States9 sites
Dermata Investigational Site
Albuquerque, New Mexico, 87106
Dermata Investigational Site
Austin, Texas, 78759
Dermata Investigational Site
College Station, Texas, 77802
Dermata Investigational Site
Henderson, Nevada, 89148
Dermata Investigational Site
High Point, North Carolina, 27262
Dermata Investigational Site
Katy, Texas, 77494
Dermata Investigational Site
Saint Joseph, Missouri, 64506
Dermata Investigational Site
San Diego, California, 92123
Dermata Investigational Site
Tennessee City, Tennessee, 37215
About this study
Official title: A Study of Tolerability, Safety, And Efficacy, of DMT310 In Patients With Acne Vulgaris
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 vulgaris.
- Conditions
- Acne Vulgaris
- Being tested
- DMT310, Hydrogen Peroxide, Placebo
- Medical subject headings
- Acne Vulgaris
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DMT310Drug
Topical Powder
Hydrogen PeroxideDrug
Liquid Diluent
PlaceboDrug
Placebo Topical Powder
| Study group | Role | What they receive |
|---|---|---|
| Study Treatment 1 | Experimental | DMT310 Powder mixed with Hydrogen Peroxide Receives: Drug: DMT310; Drug: Hydrogen Peroxide |
| Study Treatment 2 | Experimental | DMT310 Powder mixed with Placebo Diluent Receives: Drug: DMT310 |
| Study Treatment 3 | Experimental | Placebo powder mixed with Hydrogen Peroxide Receives: Drug: Hydrogen Peroxide; Drug: Placebo |
| Control | Placebo comparator | Placebo powder mixed with Placebo Diluent Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy as measured by lesion counts
Inflammatory and Noninflammatory
Measured: 12 weeks
Efficacy as measured by Investigator Global Assessment (IGA)
0 None No evidence of facial acne vulgaris
- Minimal Few noninflammatory lesions (comedones) are present; a few inflammatory lesions(papules/pustules) may be present; no nodulo-cystic lesions are allowed)
- Mild Several to many noninflammatory lesions (comedones) are present; a few inflammatory lesions (papules/pustules) are present; no nodulo-cystic lesions are allowed
- Moderate Many noninflammatory (comedones) and inflammatory lesions (papules/pustules) are present; no nodulo-cystic lesions are allowed
- Severe Significant degree of inflammatory disease; papules/pustules are a predominant feature; a few nodulo-cystic lesions may be present; comedones may be present
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 posted25 May 2018
- Study start22 May 2018
- Primary completion30 Dec 2018
- Study completion28 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acne VulgarisStudies 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
- Factorial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 121 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
- NCT03536637
- Sponsor's protocol ID
- DMT310-001
- Status last verified
- Jun 2018
- First submitted
- 2 May 2018
- Last updated
- 22 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study of Tolerability, Safety, And Efficacy, of DMT310 In Patients With Acne Vulgaris
- ClinicalTrials.gov ID
- NCT03536637
- Acronym / sponsor ID
- DMT310-001
- Conditions
- Acne Vulgaris
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 121 participants (actual)
- Lead sponsor
- Dermata TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- 22 May 2018 (actual)
- Primary completion
- 30 Dec 2018 (actual)
- Study completion
- 28 Jan 2019 (actual)
- First posted
- 25 May 2018 (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 vulgaris.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Study Treatment 1 | Experimental | Drug: DMT310, Drug: Hydrogen PeroxideDMT310 Powder mixed with Hydrogen Peroxide |
| Study Treatment 2 | Experimental | Drug: DMT310DMT310 Powder mixed with Placebo Diluent |
| Study Treatment 3 | Experimental | Drug: Hydrogen Peroxide, Drug: PlaceboPlacebo powder mixed with Hydrogen Peroxide |
| Control | Placebo comparator | Drug: PlaceboPlacebo powder mixed with Placebo Diluent |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, 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 acne vulgaris as determined by:
- Investigator's Global Assessment (IGA) at Randomization Patient has at least 20 but not more than 50 inflammatory lesions on the face Patient has at least 20 but not more than 100 noninflammatory 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 (2 listed)
- Patient is pregnant or planning to become pregnant
- Patient is taking a topical therapy on the face which may affect the patient's acne
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 |
|---|---|---|
| DMT310Topical Powder | Drug | Study Treatment 1, Study Treatment 2 |
| Hydrogen PeroxideLiquid Diluent | Drug | Study Treatment 1, Study Treatment 3 |
| PlaceboPlacebo Topical Powder | Drug | Control, Study Treatment 3 |
Primary outcome
Efficacy as measured by lesion counts
Time frame: 12 weeks
Inflammatory and Noninflammatory
Efficacy as measured by Investigator Global Assessment (IGA)
Time frame: 12 weeks
0 None No evidence of facial acne vulgaris 1. Minimal Few noninflammatory lesions (comedones) are present; a few inflammatory lesions(papules/pustules) may be present; no nodulo-cystic lesions are allowed) 2. Mild Several to many noninflammatory lesions (comedones) are present; a few inflammatory lesions (papules/pustules) are present; no nodulo-cystic lesions are allowed 3. Moderate Many noninflammatory (comedones) and inflammatory lesions (papules/pustules) are present; no nodulo-cystic lesions are allowed 4. Severe Significant degree of inflammatory disease; papules/pustules are a predominant feature; a few nodulo-cystic lesions may be present; comedones may be present
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 22 Jul 2020.
- 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 DMT310 and Hydrogen Peroxide in people with Acne Vulgaris, 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 22 Jul 2020. 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 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 22 Jul 2020.