DMT310-003 Topical in the Treatment of Acne Vulgaris

A Phase 2 study testing DMT310 in people with Acne Vulgaris, run by Dermata Therapeutics at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

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
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 181 participants
Where: 1 siteUnited States
Study dates: 10 Oct 2019to 4 May 2020
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 12 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 inflammatory lesions on the face Patient has at least 20 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

1 site in 1 country.

United States1 site

Dermata Investigational Site
Austin, Texas, 78759

Other trials in United States

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, 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
PlaceboDrug
Placebo Topical Powder

Study groups in NCT04106778
Study group	Role	What they receive
Study Treatment 1	Experimental	DMT310 Powder mixed with Hydrogen Peroxide Receives: Drug: DMT310
Study Treatment 2	Experimental	Placebo powder mixed with Hydrogen Peroxide 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
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
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.

10 Oct 20194 May 2020

First posted27 Sep 2019
Study start10 Oct 2019
Primary completion4 May 2020
Study completion4 May 2020

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: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 181 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04106778
Sponsor's protocol ID: DMT310-003
Status last verified: Sep 2019
First submitted: 25 Sep 2019
Last updated: 22 Jul 2020
Results posted: No
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruitingPhase 3
Evaluation of the Efficacy and Safety of Fractional CO₂ Laser With and Without Intradermal Botulinum Toxin A in the Treatment of Inflammatory Facial Acne Vulgaris.
Acne, Acne Papulopustulosa
RecruitingPhase 4
Safety, Tolerability, and Clinical Effectiveness of Adapalene/Clindamycin Phosphate Gel (Klenzit®-C) in Vietnamese Patients With Mild to Moderate Acne Vulgaris
Acne
RecruitingPhase 3
Phase 3 Study of Denifanstat in Participants With Moderate to Severe Acne (AURORA)
Acne Vulgaris
RecruitingPhase 4
Comparing Nadifloxacin Plus Tretinoin Versus Clindamycin Plus Tretinoin Creams for Mild-to-Moderate Acne
Acne Vulgaris
Active, not recruiting
Clinical Study to Evaluate the Safety and Efficacy of Candela Technology
Hair Reduction, Tattoo Removal

All Acne Vulgaris trials

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: NCT04106778
Acronym / sponsor ID: DMT310-003
Conditions: Acne Vulgaris
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 181 participants (actual)
Lead sponsor: Dermata TherapeuticsIndustry (pharma, biotech, devices)
Study start: 10 Oct 2019 (actual)
Primary completion: 4 May 2020 (actual)
Study completion: 4 May 2020 (actual)
First posted: 27 Sep 2019 (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: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Study Treatment 1	Experimental	Drug: DMT310DMT310 Powder mixed with Hydrogen Peroxide
Study Treatment 2	Experimental	Drug: PlaceboPlacebo powder mixed with Hydrogen Peroxide

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 12 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 inflammatory lesions on the face Patient has at least 20 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
PlaceboPlacebo Topical Powder	Drug	Study Treatment 2

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.

Related trials for Acne Vulgaris

Not yet recruitingPhase 3
Evaluation of the Efficacy and Safety of Fractional CO₂ Laser With and Without Intradermal Botulinum Toxin A in the Treatment of Inflammatory Facial Acne Vulgaris.
Acne, Acne Papulopustulosa
RecruitingPhase 4
Safety, Tolerability, and Clinical Effectiveness of Adapalene/Clindamycin Phosphate Gel (Klenzit®-C) in Vietnamese Patients With Mild to Moderate Acne Vulgaris
Acne
RecruitingPhase 3
Phase 3 Study of Denifanstat in Participants With Moderate to Severe Acne (AURORA)
Acne Vulgaris
RecruitingPhase 4
Comparing Nadifloxacin Plus Tretinoin Versus Clindamycin Plus Tretinoin Creams for Mild-to-Moderate Acne
Acne Vulgaris
Active, not recruiting
Clinical Study to Evaluate the Safety and Efficacy of Candela Technology
Hair Reduction, Tattoo Removal

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 DMT310 in people with Acne Vulgaris, 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 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 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?

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?

On the ClinicalTrials.gov record for NCT04106778.

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.