DMT310, a novel once-weekly topical treatment for patients with moderate-to-severe acne vulgaris: Results of a phase 2b randomized, double-blind, placebo-controlled trial

Lawrence F Eichenfield; Janet C DuBois; Michael H Gold; Christopher J Nardo; Zoe D Draelos; DMT310 Study Group

doi:10.1016/j.jaad.2023.05.070

DMT310, a novel once-weekly topical treatment for patients with moderate-to-severe acne vulgaris: Results of a phase 2b randomized, double-blind, placebo-controlled trial

J Am Acad Dermatol. 2023 Nov;89(5):945-951. doi: 10.1016/j.jaad.2023.05.070. Epub 2023 Jun 7.

Authors

Lawrence F Eichenfield¹, Janet C DuBois², Michael H Gold³, Christopher J Nardo⁴, Zoe D Draelos⁵; DMT310 Study Group

Collaborators

DMT310 Study Group:
E Armas, O DeValle, R S Haber, T Jones, S E Kempers, T G Knoepp, B J Kuttner, R Lieberman, M L Miller, D M Stewart, J Weinberg

Affiliations

¹ Department of Dermatology and Pediatrics, University of California San Diego and Rady Children's Hospital, San Diego, California. Electronic address: leichenfield@rchsd.org.
² DermResearch, P.A., Austin, Texas.
³ Tennessee Clinical Research Center, Nashville, Tennessee.
⁴ Dermata Therapeutics, Inc, San Diego, California.
⁵ Dermatology Consulting Services, PLLC, High Point, North Carolina.

PMID: 37295506
DOI: 10.1016/j.jaad.2023.05.070

Abstract

Background: Poor patient adherence with antiacne medications is a common clinical challenge. DMT310, a natural, topical product with a once-weekly application schedule, may alleviate this obstacle.

Objective: Evaluate the safety, tolerability, and efficacy of DMT310 in treating moderate-to-severe acne.

Methods: This 12-week, randomized, double-blind, placebo-controlled, multicenter clinical trial enrolled participants 12 years and older with moderate-to-severe acne.

Results: The intent-to-treat population included a total of 181 participants (DMT310, N = 91; placebo, N = 90). Participants who received DMT310 vs participants treated with placebo demonstrated a statistically significant greater reduction in the number of inflammatory and noninflammatory lesions at all time points: inflammatory lesion counts at week 12 (-15.64 vs -10.84, P < .001); noninflammatory lesion counts at week 12 (-18.26 vs -12.41, P < .001). DMT310-treated participants also had higher rates of Investigator's Global Assessment treatment success than participants in the placebo group at all time points: Investigator's Global Assessment at week 12 (44.40% vs 17.78%; P < .001). No serious treatment related adverse events occurred.

Conclusions: DMT310 once-weekly topical treatment significantly reduced both inflammatory and noninflammatory lesions and yielded a greater proportion of Investigator's Global Assessment treatment success at all time points in participants with moderate-to-severe acne.

Keywords: Spongilla lacustris; acne vulgaris; clinical research; general dermatology; medical dermatology; natural products; pediatric dermatology.