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
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. Evaluate the safety, tolerability, and efficacy of DMT310 in treating moderate-to-severe acne. This 12-week, rando...
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| Veröffentlicht in: | Journal of the American Academy of Dermatology 2023-11, Vol.89 (5), p.945-951 |
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| container_title | Journal of the American Academy of Dermatology |
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| creator | Eichenfield, Lawrence F. DuBois, Janet C. Gold, Michael H. Nardo, Christopher J. Draelos, Zoe D. Armas, E. DeValle, O. Haber, R.S. Jones, T. Kempers, S.E. Knoepp, T.G. Kuttner, B.J. Lieberman, R. Miller, M.L. Stewart, D.M. Weinberg, J. |
| description | 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.
Evaluate the safety, tolerability, and efficacy of DMT310 in treating moderate-to-severe acne.
This 12-week, randomized, double-blind, placebo-controlled, multicenter clinical trial enrolled participants 12 years and older with moderate-to-severe acne.
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 |
| doi_str_mv | 10.1016/j.jaad.2023.05.070 |
| format | Article |
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Evaluate the safety, tolerability, and efficacy of DMT310 in treating moderate-to-severe acne.
This 12-week, randomized, double-blind, placebo-controlled, multicenter clinical trial enrolled participants 12 years and older with moderate-to-severe acne.
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.
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.</description><identifier>ISSN: 0190-9622</identifier><identifier>EISSN: 1097-6787</identifier><identifier>DOI: 10.1016/j.jaad.2023.05.070</identifier><identifier>PMID: 37295506</identifier><language>eng</language><publisher>United States: Elsevier Inc</publisher><subject>acne vulgaris ; clinical research ; general dermatology ; medical dermatology ; natural products ; pediatric dermatology ; Spongilla lacustris</subject><ispartof>Journal of the American Academy of Dermatology, 2023-11, Vol.89 (5), p.945-951</ispartof><rights>2023 American Academy of Dermatology, Inc.</rights><rights>Copyright © 2023 American Academy of Dermatology, Inc. Published by Elsevier Inc. All rights reserved.</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><cites>FETCH-LOGICAL-c351t-bb7ff6cb596704c8f2616fb3dad2b3d917f899c8074a7debf9373018ee64c0b33</cites><orcidid>0000-0002-2760-0474</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktohtml>$$Uhttps://www.sciencedirect.com/science/article/pii/S0190962223010174$$EHTML$$P50$$Gelsevier$$Hfree_for_read</linktohtml><link.rule.ids>314,776,780,3537,27901,27902,65534</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/37295506$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Eichenfield, Lawrence F.</creatorcontrib><creatorcontrib>DuBois, Janet C.</creatorcontrib><creatorcontrib>Gold, Michael H.</creatorcontrib><creatorcontrib>Nardo, Christopher J.</creatorcontrib><creatorcontrib>Draelos, Zoe D.</creatorcontrib><creatorcontrib>Armas, E.</creatorcontrib><creatorcontrib>DeValle, O.</creatorcontrib><creatorcontrib>Haber, R.S.</creatorcontrib><creatorcontrib>Jones, T.</creatorcontrib><creatorcontrib>Kempers, S.E.</creatorcontrib><creatorcontrib>Knoepp, T.G.</creatorcontrib><creatorcontrib>Kuttner, B.J.</creatorcontrib><creatorcontrib>Lieberman, R.</creatorcontrib><creatorcontrib>Miller, M.L.</creatorcontrib><creatorcontrib>Stewart, D.M.</creatorcontrib><creatorcontrib>Weinberg, J.</creatorcontrib><creatorcontrib>DMT310 Study Group</creatorcontrib><title>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</title><title>Journal of the American Academy of Dermatology</title><addtitle>J Am Acad Dermatol</addtitle><description>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.
Evaluate the safety, tolerability, and efficacy of DMT310 in treating moderate-to-severe acne.
This 12-week, randomized, double-blind, placebo-controlled, multicenter clinical trial enrolled participants 12 years and older with moderate-to-severe acne.
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.
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.</description><subject>acne vulgaris</subject><subject>clinical research</subject><subject>general dermatology</subject><subject>medical dermatology</subject><subject>natural products</subject><subject>pediatric dermatology</subject><subject>Spongilla lacustris</subject><issn>0190-9622</issn><issn>1097-6787</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2023</creationdate><recordtype>article</recordtype><recordid>eNp9kU1vFSEUhidGY2-rf8CFYemijMDcgcG4aWr9SGpMTF0TPs5YrswwAnOb-pP8lXJzq0s3wEme88LhaZoXlLSUUP561-60di0jrGtJ3xJBHjUbSqTAXAzicbMhVBIsOWMnzWnOO0KI3HbiaXPSCSb7nvBN8_vd55uOknOk0Rz3EFCcLeA7gB_hHpW4eKsDKgl0mWAuaIwJLbr4es7ozpdbNEUHSRfAJeIMe0iAtJ0B7dfwXSef36CvkNdQ8TjWS5ZbnQExg5KeXZz8L3DnyMXVBMAm-LlWS9AWTMQ2ziXFEMDVB3gdnjVPRh0yPH_Yz5pv769uLj_i6y8fPl1eXGPb9bRgY8Q4cmt6yQXZ2mFknPLRdE47VldJxThIaQcitlo4MKPsREfoAMC3lpiuO2teHXOXFH-ukIuafLYQgp4hrlmxgW25pHwYKsqOqE0x5wSjWpKfdLpXlKiDI7VTB0fq4EiRXlVHtenlQ_5qJnD_Wv5KqcDbIwB1yr2HpLKtP27B-QS2KBf9__L_ADyupTg</recordid><startdate>20231101</startdate><enddate>20231101</enddate><creator>Eichenfield, Lawrence F.</creator><creator>DuBois, Janet C.</creator><creator>Gold, Michael H.</creator><creator>Nardo, Christopher J.</creator><creator>Draelos, Zoe D.</creator><creator>Armas, E.</creator><creator>DeValle, O.</creator><creator>Haber, R.S.</creator><creator>Jones, T.</creator><creator>Kempers, S.E.</creator><creator>Knoepp, T.G.</creator><creator>Kuttner, B.J.</creator><creator>Lieberman, R.</creator><creator>Miller, M.L.</creator><creator>Stewart, D.M.</creator><creator>Weinberg, J.</creator><general>Elsevier Inc</general><scope>6I.</scope><scope>AAFTH</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>7X8</scope><orcidid>https://orcid.org/0000-0002-2760-0474</orcidid></search><sort><creationdate>20231101</creationdate><title>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</title><author>Eichenfield, Lawrence F. ; DuBois, Janet C. ; Gold, Michael H. ; Nardo, Christopher J. ; Draelos, Zoe D. ; Armas, E. ; DeValle, O. ; Haber, R.S. ; Jones, T. ; Kempers, S.E. ; Knoepp, T.G. ; Kuttner, B.J. ; Lieberman, R. ; Miller, M.L. ; Stewart, D.M. ; Weinberg, J.</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c351t-bb7ff6cb596704c8f2616fb3dad2b3d917f899c8074a7debf9373018ee64c0b33</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2023</creationdate><topic>acne vulgaris</topic><topic>clinical research</topic><topic>general dermatology</topic><topic>medical dermatology</topic><topic>natural products</topic><topic>pediatric dermatology</topic><topic>Spongilla lacustris</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Eichenfield, Lawrence F.</creatorcontrib><creatorcontrib>DuBois, Janet C.</creatorcontrib><creatorcontrib>Gold, Michael H.</creatorcontrib><creatorcontrib>Nardo, Christopher J.</creatorcontrib><creatorcontrib>Draelos, Zoe D.</creatorcontrib><creatorcontrib>Armas, E.</creatorcontrib><creatorcontrib>DeValle, O.</creatorcontrib><creatorcontrib>Haber, R.S.</creatorcontrib><creatorcontrib>Jones, T.</creatorcontrib><creatorcontrib>Kempers, S.E.</creatorcontrib><creatorcontrib>Knoepp, T.G.</creatorcontrib><creatorcontrib>Kuttner, B.J.</creatorcontrib><creatorcontrib>Lieberman, R.</creatorcontrib><creatorcontrib>Miller, M.L.</creatorcontrib><creatorcontrib>Stewart, D.M.</creatorcontrib><creatorcontrib>Weinberg, J.</creatorcontrib><creatorcontrib>DMT310 Study Group</creatorcontrib><collection>ScienceDirect Open Access Titles</collection><collection>Elsevier:ScienceDirect:Open Access</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>MEDLINE - Academic</collection><jtitle>Journal of the American Academy of Dermatology</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Eichenfield, Lawrence F.</au><au>DuBois, Janet C.</au><au>Gold, Michael H.</au><au>Nardo, Christopher J.</au><au>Draelos, Zoe D.</au><au>Armas, E.</au><au>DeValle, O.</au><au>Haber, R.S.</au><au>Jones, T.</au><au>Kempers, S.E.</au><au>Knoepp, T.G.</au><au>Kuttner, B.J.</au><au>Lieberman, R.</au><au>Miller, M.L.</au><au>Stewart, D.M.</au><au>Weinberg, J.</au><aucorp>DMT310 Study Group</aucorp><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>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</atitle><jtitle>Journal of the American Academy of Dermatology</jtitle><addtitle>J Am Acad Dermatol</addtitle><date>2023-11-01</date><risdate>2023</risdate><volume>89</volume><issue>5</issue><spage>945</spage><epage>951</epage><pages>945-951</pages><issn>0190-9622</issn><eissn>1097-6787</eissn><abstract>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.
Evaluate the safety, tolerability, and efficacy of DMT310 in treating moderate-to-severe acne.
This 12-week, randomized, double-blind, placebo-controlled, multicenter clinical trial enrolled participants 12 years and older with moderate-to-severe acne.
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.
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.</abstract><cop>United States</cop><pub>Elsevier Inc</pub><pmid>37295506</pmid><doi>10.1016/j.jaad.2023.05.070</doi><tpages>7</tpages><orcidid>https://orcid.org/0000-0002-2760-0474</orcidid><oa>free_for_read</oa></addata></record> |
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| identifier | ISSN: 0190-9622 |
| ispartof | Journal of the American Academy of Dermatology, 2023-11, Vol.89 (5), p.945-951 |
| issn | 0190-9622 1097-6787 |
| language | eng |
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| source | Elsevier ScienceDirect Journals |
| subjects | acne vulgaris clinical research general dermatology medical dermatology natural products pediatric dermatology Spongilla lacustris |
| title | 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 |
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