TOPLINE:
DMT310, a novel topical treatment applied once per week, appears to be safe and effective for moderate-to-severe acne.
METHODOLOGY:
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Poor patient compliance with topical acne therapies is a common clinical challenge.
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In a 12-week, randomized, controlled, phase 2b trial of 181 patients 12 years of age and older, researchers investigated the safety, tolerability, and efficacy of DMT310, a powdered mixture of Spongilla lacustris for treating moderate-to-severe acne. (In vitro studies have found that components of S. lacustris, a freshwater sponge, have effects that include antimicrobial activity against Cutibacterium acnes and anti-inflammatory activity in human keratinocytes).
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The study’s primary efficacy endpoint was the absolute change in inflammatory lesion (IL) count from baseline to week 12.
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Endpoint success was defined as an Investigator Global Assessment (IGA) score of 0 or 1 and at least a two-grade improvement from baseline at week 12.
TAKEAWAY:
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Of the 181 patients, 91 received DMT310 (applied once a week to the face and washed off after 10 to 15 minutes), and 90 received placebo.
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Patients in the DMT310 arm showed a significantly greater mean reduction in the number of inflammatory lesions at week 12 compared with those in the placebo arm (–15.64 vs –10.84, respectively; P < .001).
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Similarly, patients in the DMT310 arm showed a significantly greater mean reduction in the number of noninflammatory lesions at week 12 compared with those in the placebo arm (–18.26 vs –12.41, respectively; P < .001).
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At week 12, endpoint success based on IGA scores also significantly favored patients in the DMT310 arm compared with those in the placebo arm (44.40% vs 17.78%; P < .001).
IN PRACTICE:
This study is too preliminary to have practice application. The researchers concluded that the findings “support further study of DMT310 in larger, confirmatory phase 3 trials.”
SOURCE:
Lawrence F. Eichenfield, MD, professor of dermatology and pediatrics at the University of California, San Diego, led the research. The study was published online June 7 in the Journal of the American Academy of Dermatology.
LIMITATIONS:
The analysis did not include an active comparator group and it enrolled a limited number of Asian patients.
DISCLOSURES:
Eichenfield disclosed that he is a consultant to Dermata, which is developing DMT310, as were three other authors of the study. One author is a company employee. the remaining authors have disclosed no relevant financial relationships.
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