Topical DMT310 for Acne

No longer recruiting at 2 trial locations

Overseen By Dermata Study Director

Age: Any Age

Sex: Any

Trial Phase: Phase 3

Sponsor: Dermata Therapeutics

Must not be taking: Topical acne treatments

Disqualifiers: Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new topical treatment called DMT310 (also known as Xyngari) for individuals with moderate to severe acne. The goal is to assess the treatment's safety and effectiveness when applied to the face. Participants will use either DMT310 or a placebo powder (a non-active version) to compare results. Those with at least 20 inflamed and 20 non-inflamed acne spots on their face, who are not using other facial treatments, may be suitable for this study. As a Phase 3 trial, this is the final step before FDA approval, offering participants the opportunity to contribute to the potential availability of a new acne treatment.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot use any topical treatments on your face that might affect your acne.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that DMT310, a cream for acne, is generally safe. In earlier studies, people using DMT310 experienced few side effects, indicating minimal unwanted reactions. Importantly, no serious side effects occurred, suggesting it is unlikely to cause major harm. The results also indicate that DMT310 works effectively, offering promise for those with moderate to severe acne. This evidence supports DMT310 as both a safe and effective treatment option for acne. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for acne?

Unlike the standard acne treatments like benzoyl peroxide, salicylic acid, or oral antibiotics, DMT310 is unique because it combines a novel topical powder with hydrogen peroxide. This combination potentially offers a new mechanism of action, targeting acne in a way that could enhance effectiveness and reduce bacteria differently than existing treatments. Researchers are excited because this method may improve results and reduce side effects, offering a promising alternative for those who haven’t found success with current options.

What evidence suggests that DMT310 might be an effective treatment for acne?

Research has shown that DMT310, a cream for acne, delivers promising results. In studies, users of DMT310 experienced a noticeable decrease in both red, swollen pimples and smaller, non-swollen ones. In this trial, participants will receive either DMT310 or a placebo. The treatment met its main goals, with patients seeing an average reduction of 16.8 red pimples compared to 13.1 with a placebo. This suggests that DMT310 might effectively treat moderate to severe acne. ^{1 2 4 6 7}

Are You a Good Fit for This Trial?

This trial is for males and non-pregnant females aged 9 or older with moderate to severe facial acne. Participants must have at least 20 inflammatory and 20 noninflammatory lesions on their face, be willing to apply the treatment as directed, and follow the study rules.

Inclusion Criteria

I am a male or a non-pregnant female aged 9 or older.

You are willing to use the study drug as instructed.

You are willing and able to follow the study rules.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive DMT310 or placebo topical powder for acne vulgaris

12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• DMT310

Trial Overview The trial is testing DMT310, a topical powder mixed with diluent against a placebo (a substance with no active drug) to see if it's safe, tolerable, and effective in treating facial acne vulgaris.

How Is the Trial Designed?

Group I: Placebo Topical Powder Experimental Treatment 1 Intervention

Placebo powder mixed with Hydrogen Peroxide

Group II: DMT310 Topical Powder Experimental Treatment 1 Intervention

DMT310 Powder mixed with Hydrogen Peroxide

Who Is Running the Clinical Trial?

Dermata Therapeutics

Lead Sponsor

Trials

6

Recruited

1,200+

Published Research Related to This Trial

Topical tazarotene 0.1% gel and cream demonstrated superior efficacy compared to other topical retinoids like adapalene and tretinoin in treating mild to moderate acne, based on a meta-analysis of 6 trials involving 468 patients over 12 weeks.

The treatment was found to be effective and well-tolerated across various patient characteristics, including acne severity, skin type, sex, and ethnicity, with the cream formulation offering better tolerability than the gel.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Meta-analysis of topical tazarotene in the treatment of mild to moderate acne. Leyden, JJ.[2015]

Innovative treatments for acne are being developed, including new topical formulations using lipid nanoparticles and microspheres that enhance the delivery and tolerance of anti-androgens and retinoids.

Emerging therapies such as topical antimicrobial peptides, dapsone for isotretinoin-resistant cases, and phototherapy with narrowband light show promise, alongside the potential development of acne vaccines.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[What's new in acne? New therapeutic approaches]. Bettoli, V., Sarno, O., Zauli, S., et al.[2010]

Topical treatments like benzoyl peroxide, clindamycin, and retinoids are effective for mild to moderate acne but often cause irritation, leading to poor patient adherence.

New formulations that improve drug delivery and tolerability are being developed, allowing for better efficacy and less frequent application, which can enhance patient compliance in acne treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Topical Vehicle Formulations in the Treatment of Acne. Hoffman, LK., Bhatia, N., Zeichner, J., et al.[2018]

In a study involving 18 patients with moderate to severe acne, treatment with photodynamic therapy using 5-aminolevulinic acid (ALA) resulted in an average acne grade improvement of 1.75, with 11 out of 12 patients reporting at least 50% improvement.

The treatment was generally safe, with only mild side effects like erythema and peeling lasting up to five days, indicating that ALA-PDT can be an effective and well-tolerated option for acne management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Photodynamic therapy for the treatment of acne: a pilot study. Taub, AF.[2013]

Topical tetracycline (Tc) loaded in solid lipid microparticles (SLMs) showed significantly enhanced skin penetration, with dermal deposition about 7 times greater than traditional aqueous carbopol gel formulations, indicating improved efficacy for acne treatment.

The SLMs demonstrated high encapsulation efficiency (over 97%) and a sustained release pattern, which may help reduce side effects associated with tetracycline while providing effective therapy for acne vulgaris.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Solid lipid microparticles for enhanced dermal delivery of tetracycline HCl. Rahimpour, Y., Javadzadeh, Y., Hamishehkar, H.[2017]

In a study involving 8 patients with moderate-to-severe acne, the use of the photosensitizer 5-aminolevulinic acid (ALA) combined with a 532 nm laser resulted in a 52% improvement in acne on the treated side compared to a 32% improvement on the untreated side.

Overall, the average acne grading improved from 3.20 to 2.12 over 12 weeks, indicating that ALA combined with light therapy is a promising alternative to traditional acne treatments, though further research is needed to optimize treatment parameters.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An open-label, split-face study comparing the safety and efficacy of levulan kerastick (aminolevulonic acid) plus a 532 nm KTP laser to a 532 nm KTP laser alone for the treatment of moderate facial acne. Sadick, N.[2013]

In a pilot study involving 20 patients with mild to moderate acne, both clindamycin-tretinoin (CT) and benzoyl peroxide-adapalene (BA) showed similar efficacy in reducing acne lesions, indicating they are effective treatment options.

However, CT was better tolerated than BA, with lower reports of irritation and side effects, making it a more favorable choice for patients despite BA being perceived as more effective in improving acne.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tolerability and Efficacy of Clindamycin/Tretinoin versus Adapalene/Benzoyl Peroxide in the Treatment of Acne Vulgaris. Aschoff, R., Möller, S., Haase, R., et al.[2021]

A systematic review of 19 clinical trials involving 587 patients found that optical treatments, particularly photodynamic therapy (PDT), can significantly improve inflammatory acne in the short term, with improvements of up to 68%.

While optical treatments show promise, they are not considered first-line therapies for acne vulgaris, and patients should be informed about potential side effects such as pain and hyperpigmentation, especially with treatments involving aminolevulinic acid (ALA) or methyl-aminolevulinic acid (MAL).

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evidence-based review of lasers, light sources and photodynamic therapy in the treatment of acne vulgaris. Haedersdal, M., Togsverd-Bo, K., Wulf, HC.[2018]

Citations

1. ir.dermatarx.com ir.dermatarx.com/news-events/press-releases/detail/82/breaking-dermatas-xyngari-phase-3-trial-topline-data

BREAKING: Dermata's XYNGARI™ Phase 3 Trial Topline ... XYNGARI™ achieved its primary endpoints, demonstrating highly statistically significant and clinically meaningful improvement in acne -.

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37295506/

DMT310, a novel once-weekly topical treatment for patients ... Conclusions: DMT310 once-weekly topical treatment significantly reduced both inflammatory and noninflammatory lesions and yielded a greater ...

3. prnewswire.com prnewswire.com/news-releases/breaking-dermatas-xyngari-phase-3-trial-topline-data-meets-all-primary-endpoints-302412922.html

BREAKING: Dermata's XYNGARI™ Phase 3 Trial Topline ... XYNGARI™ achieved its primary endpoints, demonstrating highly statistically significant and clinically meaningful improvement in acne -.

4. sciencedirect.com sciencedirect.com/science/article/pii/S0190962223010174

DMT310, a novel once-weekly topical treatment for patients ... In a recent review of topical acne medications, it was reported that the IGA treatment success rates ranged from 16% to 38% at week 12. Participants treated ...

5. dermatologytimes.com dermatologytimes.com/view/topical-xyngari-meets-all-primary-endpoints-in-phase-3-study-for-moderate-to-severe-acne

Topical Xyngari Meets All Primary Endpoints in Phase 3 ... Patients in the Xyngari treatment group experienced an average reduction of 16.8 inflammatory lesions, versus 13.1 lesions in the placebo group ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT03536637

DMT310-001 Topical in the Treatment of 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 ...

7. acneandrosacea.org acneandrosacea.org/blog/dermata-first-phase-3-trial-for-xyngari-now-complete/

Dermata: First Phase 3 Trial for Xyngari Now Complete The Xyngari Phase 3 STAR-1 clinical study is evaluating the efficacy, safety, and tolerability of the topical candidate in patients with moderate-to-severe ...