Age: Any Age
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 3
Recruiting
Sponsor: Dermata Therapeutics
Must not be taking: Topical acne treatments
Disqualifiers: Pregnancy, others
No Placebo Group
Pivotal Trial (Near Approval)
Prior Safety Data
Trial Summary
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
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.
12345What 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.
13678Eligibility 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.
+1 more
Trial 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
Participant Groups
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.
2Treatment groups
Experimental Treatment
Group I: Placebo Topical PowderExperimental Treatment1 Intervention
Placebo powder mixed with Hydrogen Peroxide
Group II: DMT310 Topical PowderExperimental Treatment1 Intervention
DMT310 Powder mixed with Hydrogen Peroxide
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Center for Dermatology Clinical Research, Inc.Fremont, CA
DermResearchAustin, TX
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Who Is Running the Clinical Trial?
Dermata TherapeuticsLead Sponsor
References
[What's new in acne? New therapeutic approaches]. [2010]Well-known topical and systemic treatments for acne have advanced little over the last 10 years. However, many therapeutic approaches are being evaluated both in terms of topical and systemic treatments. The purpose of this paper is to show the progress of innovative drug projects in treating acne. The topical use of new formulations using lipid nanoparticles and microspheres could help for new products based on anti-androgens or retinoids more concentrated and better tolerated. New active agents such as topical antimicrobial peptides, inhibitors of ectopeptidase, omiganan pentahydrochloride, antisense oligonucleotides, lauric acid are many original ways to explore for the treatment of acne. New treatment regimens for doxycycline and isotretinoin would increase tolerance. Dapsone has been evaluated for isotretinoin-resistant forms. Phototherapy narrowband light (blue or red) can find its place in the strategy for the management of acne. Finally, acne vaccines could be developed too.
Topical Vehicle Formulations in the Treatment of Acne. [2018]Topical treatment is the mainstay of acne therapy. The most commonly prescribed topical medications for acne include benzoyl peroxide, clindamycin, and retinoids. Despite their effectiveness in treating mild to moderate acne vulgaris, these topical medications are found to be irritating, and are historically associated with poor tolerability and diminished patient adherence. Thus, choosing the right formulation that will be effective and well tolerated is essential. Novel formulations that optimize drug concentration and utilize improved delivery vehicles have helped to enhance the tolerability and efficacy, and allow for less frequent application or co-application of drugs that were previously considered incompatible. This article will review the goals of topical therapy for the treatment of acne, in addition to common therapies and their challenges. Advanced formulations and combination formulations of benzoyl peroxide, clindamycin, and tretinoin will also be discussed. J Drugs Dermatol. 2018;17(6 Suppl):s6-10.
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]Recent advances in light therapy coupled with photosensitizers offer alternatives to topical creams and gels and systemic oral agents for acne treatment. To examine the safety and efficacy of the photosensitizer 5-aminolevulinic acid (ALA) in patients with moderate-to-severe acne, a randomized, split-face study, using ALA on one side of the face, was followed by exposure of the entire face to 532 nm potassium titanyl phosphate (KTP) laser. Eight patients completed three treatments for up to 12 weeks. The average acne grading at baseline was 3.20, and improved to 2.12 at 12 weeks (34% improvement). Use of ALA improved acne by 52% compared with 32% on the side that did not receive the photosensitizer. Further studies are warranted to establish optimal parameters for photosensitizer use combined with light therapy for treatment of moderate-to-severe acne; however, the combined use of ALA and a 532 nm laser suggests promising results for acne treatment.
Tolerability and Efficacy of Clindamycin/Tretinoin versus Adapalene/Benzoyl Peroxide in the Treatment of Acne Vulgaris. [2021]Acne vulgaris is the most common dermatological disorder worldwide, causing significant physical and psychological morbidity. Topical combination therapy has shown superior efficacy compared to monotherapy, especially when combined with retinoids. Few studies have directly compared combined formulations. This evaluator-blinded pilot study compared the efficacy and tolerability of two marketed topical combination acne gels, clindamycin 1%-tretinoin 0.025% (CT) and benzoyl peroxide 2.5%-adapalene 0.1% (BA) in 20 patients with mild to moderate acne vulgaris. Gels were applied daily on opposite sides of the face for 21 days. The primary outcome was difference in transepidermal water loss (TEWL) at the end of treatment. Secondary endpoints were skin moisture content measurement, Investigators' Global Assessment, subject self-assessments (SSA) of burning/stinging, itching, erythema, and dryness/scaling, and Comparative Participant Satisfaction Questionnaire (CPSQ). Efficacy was assessed by inflammatory and non- inflammatory acne efflorescences counts. TEWL increased significantly for both CT and BA (+57.74%, P=0.002; +58.77%, P<0.001); skin moisture content significantly decreased only for BA (-16.47%, P=0.02). Only BA showed a significant increase in erythema and dryness/scaling (P=0.027 and P=0.014) and in SSA burning/stinging (P=0.04). Patient satisfaction evaluation also reflected the strong BA irritation. Although CT and BA both reduced acne lesions (P<0.001) and more patients preferred to continue with CT, subject perception of acne improvement was higher for BA. These findings suggest that CT and BA have similar efficacy in the treatment of mild to moderate papulopustular acne. However, CT was better tolerated than BA by both medical and subject evaluation. CT is an effective and tolerated treatment option.J Drugs Dermatol. 2021;20(3):295-301. doi:10.36849/JDD.2021.5641.
Evidence-based review of lasers, light sources and photodynamic therapy in the treatment of acne vulgaris. [2018]Background There is a considerable need for effective and safe treatment for acne vulgaris. Objective In a systematic review with an evidence-based approach to assess the effects of optical treatments for acne vulgaris. Methods Original publications of controlled clinical trials were identified through searches in PubMed and the Cochrane Library. Results A total of 16 randomized controlled trials (RCT) and 3 controlled trials (CT) were identified, involving a total of 587 patients. Interventions included photodynamic therapy (PDT; 5 RCTs), infrared lasers (4 RCTs), broad-spectrum light sources (3 RCTs, 1 CT), pulsed dye lasers (PDL; 2 RCTs, 1 CT), intense pulsed light (IPL; 1 RCTs, 2 CTs), and potassium titanyl phosphate laser (1 RCT). The randomization method was mentioned in 6 of 16 RCTs, and one trial described adequate allocation concealment. Most trials were intraindividual trials (12 of 19), which applied blinded response evaluations (12 of 19) and assessed a short-term efficacy up to 12 weeks after treatment (17 of 19). Based on the present best available evidence, we conclude that optical treatments possess the potential to improve inflammatory acne on a short-term basis with the most consistent outcomes for PDT [up to 68% improvement, aminolevulinic acid (ALA), methyl-aminolevulinic acid (MAL) and red light]. IPL-assisted PDT seems to be superior to IPL alone. Only two trials compare optical vs. conventional treatments, and further studies are needed. Side-effects from optical treatments included pain, erythema, oedema, crusting, hyperpigmentation, pustular eruptions and were more intense for treatments combined with ALA or MAL. Conclusion Evidence from controlled clinical trials indicates a short-term efficacy from optical treatments for acne vulgaris with the most consistent outcomes for PDT. We recommend that patients are preoperatively informed of the existing evidence, which indicates that optical treatments today are not included among first line treatments.
Photodynamic therapy for the treatment of acne: a pilot study. [2013]Photodynamic therapy (PDT) with use of topical 5-aminolevulinic acid (ALA, Levulan Kerastick, Dusa Pharmaceuticals, Inc., Wilmington, MA) photosensitizing agent is a new modality for the treatment of acne. Eighteen patients (aged 15 to 63) with moderate to severe inflammatory acne received ALA-PDT. ALA remained in contact with skin for 15 to 30 minutes before exposure to blue light (ClearLight [Lumenis] or BLU-U [Dusa Pharmaceuticals, Inc.]) or the Aurora DSR (Syneron Medical Ltd.), which uses Electro-Optical Synergy (ELOS), a unique combination of optical and radiofrequency (RF) energy. Patients received two to four ALA-PDT treatments over four to eight weeks or two cycles of ALA-PDT (weeks 2, 4) preceded by salicylic acid peel (weeks 1, 3) over four weeks. The average follow-up time was four months. On a scale of 0.0 to 4.0, the average acne grade improvement was 1.75. Among the 12 patients who said their acne had improved, 11 had at least 50% improvement and five had more than 75% improvement. Adverse effects were limited to erythema and peeling for up to five days after treatment and one episode of impetiginization of the affected area. Patients with moderate to severe acne can achieve durable improvement with short-contact ALA-PDT.
Solid lipid microparticles for enhanced dermal delivery of tetracycline HCl. [2017]Acne vulgaris (commonly called acne) is a most common skin disease during adolescence, afflicting more than 85% of teenagers. Topical tetracycline (Tc) is used for mild inflammatory acne and as an adjunct to systemic treatment in more severe forms. Solid lipid microparticles (SLMs) are useful tool for topical delivery because of their biodegradable, biocompatible and low toxic characteristic accompanying with excellent skin hydration, occlusiveness and controlled release properties. The purpose of this study was to prepare Tc-loaded SLMs were produced by the spray drying technique and characterized by scanning electron microscopy, powder X-ray diffractometry and differential scanning calorimetry. In vitro and ex vivo release characteristics of Tc through SLMs and control formulations (aqueous carbopol gel) were evaluated over 24h using a vertical Franz diffusion cell through cellulose acetate membranes and exercised rat skin, respectively. SLM formulations present high encapsulation values above 97% without significant different among formulations (p
Meta-analysis of topical tazarotene in the treatment of mild to moderate acne. [2015]Topical tazarotene has shown superior efficacy over other topical retinoids, including adapalene and tretinoin, in the treatment of mild to moderate acne. A meta-analysis of data from 6 multicenter, double-blind, randomized comparative trials was performed to determine how patient characteristics influence the efficacy and tolerability of topical tazarotene. Data on 468 patients who used tazarotene 0.1% gel or cream once daily for 12 weeks were collected. Topical tazarotene was effective and well tolerated, regardless of patients' acne severity, skin type, sex, or ethnicity. In general, 'using the cream formulation rather than the gel formulation optimized tolerability. These results indicate that topical tazarotene 0.1% gel and cream are efficacious and well-tolerated treatment options for clearing acne vulgaris across a broad range of patients.