Topical DMT310 for Acne

Recruiting at 1 trial location

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

555 Participants Needed

Trial Summary

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.

What data supports the effectiveness of the drug DMT310, Xyngari, for treating acne?

The research highlights that new topical formulations, including those using lipid nanoparticles and microspheres, are being explored for acne treatment, which may enhance the effectiveness and tolerability of treatments like DMT310. Additionally, combination therapies and advanced formulations have shown improved efficacy and tolerability in acne treatment, suggesting potential benefits for DMT310. ^{1 2 3 4 5}

What makes the drug DMT310 unique for treating acne?

DMT310, also known as Xyngari, is a novel topical treatment for acne that may offer a unique mechanism of action or formulation compared to existing treatments, although specific details about its uniqueness are not provided in the available research. ^{1 3 6 7 8}

What is the purpose of this trial?

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

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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]

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]

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]

References

1. France pubmed.ncbi.nlm.nih.gov

[What's new in acne? New therapeutic approaches]. [2010]

2. United States pubmed.ncbi.nlm.nih.gov

Topical Vehicle Formulations in the Treatment of Acne. [2018]

3. United States 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. [2013]

4. United States pubmed.ncbi.nlm.nih.gov

Tolerability and Efficacy of Clindamycin/Tretinoin versus Adapalene/Benzoyl Peroxide in the Treatment of Acne Vulgaris. [2021]

5. England pubmed.ncbi.nlm.nih.gov

Evidence-based review of lasers, light sources and photodynamic therapy in the treatment of acne vulgaris. [2018]

6. United States pubmed.ncbi.nlm.nih.gov

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

7. Netherlands pubmed.ncbi.nlm.nih.gov

Solid lipid microparticles for enhanced dermal delivery of tetracycline HCl. [2017]

8. United States pubmed.ncbi.nlm.nih.gov

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