JAMA Dermatology

<jats:sec><jats:title>Introduction</jats:title><jats:p>A low-dose modified formulation of minocycline hydrochloride, DFD-29, is under evaluation for treating papulopustular rosacea (PPR).</jats:p></jats:sec><jats:sec><jats:title>Objective</jats:title><jats:p>To determine the efficacy and safety of DFD-29, 40 mg, compared with doxycycline, 40 mg, and placebo for treating PPR.</jats:p></jats:sec><jats:sec><jats:title>Design, Setting, and Participants</jats:title><jats:p>This study included data from 2 double-blind, placebo-controlled, phase 3 randomized clinical trials (MVOR-1 and MVOR-2) conducted between March 2022 and May 2023 at 61 centers in the US and Germany. Healthy adults 18 years and older with moderate to severe PPR were included.</jats:p></jats:sec><jats:sec><jats:title>Interventions</jats:title><jats:p>Participants were randomized 3:3:2 to oral DFD-29 (minocycline hydrochloride capsules), 40 mg; doxycycline, 40 mg; or placebo once daily for 16 weeks.</jats:p></jats:sec><jats:sec><jats:title>Main Outcomes and Measures</jats:title><jats:p>The coprimary efficacy outcomes were (1) proportion of participants with Investigator’s Global Assessment (IGA) treatment success with DFD-29 vs placebo and (2) total inflammatory lesion count reductions with DFD-29 vs placebo. Secondary outcomes included comparisons between DFD-29 and doxycycline in coprimary outcomes and between DFD-29 and placebo in erythema reduction.</jats:p></jats:sec><jats:sec><jats:title>Results</jats:title><jats:p>Of 653 participants enrolled, 323 were randomized in MVOR-1 (247 [76.5%] women; mean [SD] age, 47.2 [13.7] years) and 330 were randomized in MVOR-2 (249 [75.5%] women; mean [SD] age, 51.6 [14.0] years). DFD-29 demonstrated superior efficacy in IGA success rates compared with placebo (MVOR-1: treatment difference [TD], 32.9%; 95% CI, 19.6-46.2; <jats:italic>P</jats:italic> &amp;amp;lt; .001; MVOR-2: TD, 34.1%; 95% CI, 21.3-46.8; <jats:italic>P</jats:italic> &amp;amp;lt; .001) and compared with doxycycline (MVOR-1: TD, 18.0%; 95% CI, 5.0-31.1; <jats:italic>P</jats:italic> = .01; MVOR-2: TD, 28.3%; 95% CI, 17.4-39.3; <jats:italic>P</jats:italic> &amp;amp;lt; .001). DFD-29 also showed superior efficacy in least-squares mean reductions in total inflammatory lesions vs placebo (MVOR-1: TD, −9.2; 95% CI, −11.5 to −6.9; <jats:italic>P</jats:italic> &amp;amp;lt; .001; MVOR-2: TD, −6.8; 95% CI, −8.9 to −4.8; <jats:italic>P</jats:italic> &amp;amp;lt; .001) and doxycycline (MVOR-1: TD, −4.7; 95% CI, −6.7 to −2.8; <jats:italic>P</jats:italic> &amp;amp;lt; .001; MVOR-2: TD, −3.5; 95% CI, −5.4 to −1.6; <jats:italic>P</jats:italic> &amp;amp;lt; .001). Adverse events with DFD-29, doxycycline, and placebo were reported in 32 of 121 (26.4%), 25 of 116 (21.6%), and 27 of 76 (35.5%), respectively, in MVOR-1 and 51 of 122 (41.8%), 40 of 121 (33.1%), and 30 of 82 (36.6%), respectively, in MVOR-2. The most common adverse events with DFD-29, doxycycline, and placebo were nasopharyngitis, reported in 4 of 121 (3.3%), 2 of 116 (1.7%), and 3 of 76 (3.9%), respectively, in MVOR-1 and 13 of 122 (10.7%), 10 of 121 (8.3%), and 13 of 82 (15.9%), respectively, in MVOR-2, and COVID-19, reported in 4 of 121 (3.3%), 3 of 116 (2.6%), and 4 of 76 (5.3%) in MVOR-1 and 7 of 122 (5.7%), 8 of 121 (6.6%), and 5 of 82 (6.1%) in MVOR-2.</jats:p></jats:sec><jats:sec><jats:title>Conclusions and Relevance</jats:title><jats:p>In this study, DFD-29 was superior in efficacy to both doxycycline and placebo and demonstrated a favorable risk-benefit profile in the treatment of PPR.</jats:p></jats:sec><jats:sec><jats:title>Trial Registration</jats:title><jats:p>ClinicalTrials.gov Identifiers: <jats:ext-link xmlns:xlink="http://www.w3.org/1999/xlink" ext-link-type="uri" xlink:href="https://clinicaltrials.gov/study/NCT05296629">NCT05296629</jats:ext-link> and <jats:ext-link xmlns:xlink="http://www.w3.org/1999/xlink" ext-link-type="uri" xlink:href="https://clinicaltrials.gov/study/NCT05343455">NCT05343455</jats:ext-link></jats:p></jats:sec>

Incidence and prevalence of rosacea: a systematic review and meta-analysis.

Br J Dermatol

Rosacea: diagnosis and treatment.

Am Fam Physician

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Interventions for rosacea.

Cochrane Database Syst Rev

Update on the management of rosacea from the American Acne & Rosacea Society (AARS).

J Clin Aesthet Dermatol

Consensus recommendations from the American Acne & Rosacea Society on the management of rosacea, part 2: a status report on topical agents.

Cutis

Effect of doxycycline on the generation of reactive oxygen species: a possible mechanism of action of acne therapy with doxycycline.

Acta Derm Venereol

Doxycycline reduces lipopolysaccharide-induced inflammatory mediator secretion in macrophage and ex vivo human whole blood models.

J Periodontol

Tetracycline compounds with non-antimicrobial organ protective properties: possible mechanisms of action.

Pharmacol Res

Doxycycline modulates nitric oxide production in murine lung epithelial cells.

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Antimicrob Agents Chemother

Chemically modified non-antimicrobial tetracyclines inhibit activity of phospholipases A2.

J Rheumatol

Excessive matrix metalloproteinase activity in diabetes: inhibition by tetracycline analogues with zinc reactivity.

Curr Med Chem

Effects of antibiotics on human polymorphonuclear leukocyte chemotaxis in vitro.

Br J Oral Maxillofac Surg

Clinical significance of brand versus generic formulations: focus on oral minocycline.

Minocycline for acne vulgaris: efficacy and safety.

A review of systemic minocycline side effects and topical minocycline as a safer alternative for treating acne and rosacea.

Antibiotics (Basel)

Minocycline extended-release comparison with doxycycline for the treatment of rosacea: a randomized, head-to-head, clinical trial.

World Medical Association Declaration of Helsinki: ethical principles for medical research involving human subjects.

JAMA

Reliability of Clinician Erythema Assessment grading scale.

J Am Acad Dermatol

Two randomized phase III clinical trials evaluating anti-inflammatory dose doxycycline (40-mg doxycycline, USP capsules) administered once daily for treatment of rosacea.

Guidelines of care for the management of acne vulgaris.

Minocycline-induced hyperpigmentation.

J Community Hosp Intern Med Perspect

Comedonal diffusion of minocycline in acne.

Dermatology

Nonantibiotic properties of tetracyclines in rosacea and their clinical implications.

Minocycline: far beyond an antibiotic.

Br J Pharmacol

Minocycline affects human neutrophil respiratory burst and transendothelial migration.

Inflamm Res

Determination of minimum inhibitory concentrations.

J Antimicrob Chemother

Combined effect of anti-inflammatory dose doxycycline (40-mg doxycycline, usp monohydrate controlled-release capsules) and metronidazole topical gel 1% in the treatment of rosacea.

J Drugs Dermatol

Phenotypic and genotypic characterization of antibiotic-resistant Propionibacterium acnes isolated from acne patients attending dermatology clinics in Europe, the U.S.A., Japan and Australia.

Doxycycline, not minocycline, induces its own resistance in multidrug-resistant, community-associated methicillin-resistant Staphylococcus aureus clone USA300.

Clin Infect Dis

Topical ivermectin 10 mg/g and oral doxycycline 40 mg modified-release: current evidence on the complementary use of anti-inflammatory rosacea treatments.

Adv Ther

Alterations of human skin microbiome and expansion of antimicrobial resistance after systemic antibiotics.

Sci Transl Med

Long-term use of subantimicrobial dose doxycycline does not lead to changes in antimicrobial susceptibility.

A low-dose modified formulation of minocycline hydrochloride, DFD-29, is under evaluation for treating papulopustular rosacea (PPR).
To determine the efficacy and safety of DFD-29, 40 mg, compared with doxycycline, 40 mg, and placebo for treating PPR.
This study included data from 2 double-blind, placebo-controlled, phase 3 randomized clinical trials (MVOR-1 and MVOR-2) conducted between March 2022 and May 2023 at 61 centers in the US and Germany. Healthy adults 18 years and older with moderate to severe PPR were included.
Participants were randomized 3:3:2 to oral DFD-29 (minocycline hydrochloride capsules), 40 mg; doxycycline, 40 mg; or placebo once daily for 16 weeks.
The coprimary efficacy outcomes were (1) proportion of participants with Investigator's Global Assessment (IGA) treatment success with DFD-29 vs placebo and (2) total inflammatory lesion count reductions with DFD-29 vs placebo. Secondary outcomes included comparisons between DFD-29 and doxycycline in coprimary outcomes and between DFD-29 and placebo in erythema reduction.
Of 653 participants enrolled, 323 were randomized in MVOR-1 (247 [76.5%] women; mean [SD] age, 47.2 [13.7] years) and 330 were randomized in MVOR-2 (249 [75.5%] women; mean [SD] age, 51.6 [14.0] years). DFD-29 demonstrated superior efficacy in IGA success rates compared with placebo (MVOR-1: treatment difference [TD], 32.9%; 95% CI, 19.6-46.2; P < .001; MVOR-2: TD, 34.1%; 95% CI, 21.3-46.8; P < .001) and compared with doxycycline (MVOR-1: TD, 18.0%; 95% CI, 5.0-31.1; P = .01; MVOR-2: TD, 28.3%; 95% CI, 17.4-39.3; P < .001). DFD-29 also showed superior efficacy in least-squares mean reductions in total inflammatory lesions vs placebo (MVOR-1: TD, -9.2; 95% CI, -11.5 to -6.9; P < .001; MVOR-2: TD, -6.8; 95% CI, -8.9 to -4.8; P < .001) and doxycycline (MVOR-1: TD, -4.7; 95% CI, -6.7 to -2.8; P < .001; MVOR-2: TD, -3.5; 95% CI, -5.4 to -1.6; P < .001). Adverse events with DFD-29, doxycycline, and placebo were reported in 32 of 121 (26.4%), 25 of 116 (21.6%), and 27 of 76 (35.5%), respectively, in MVOR-1 and 51 of 122 (41.8%), 40 of 121 (33.1%), and 30 of 82 (36.6%), respectively, in MVOR-2. The most common adverse events with DFD-29, doxycycline, and placebo were nasopharyngitis, reported in 4 of 121 (3.3%), 2 of 116 (1.7%), and 3 of 76 (3.9%), respectively, in MVOR-1 and 13 of 122 (10.7%), 10 of 121 (8.3%), and 13 of 82 (15.9%), respectively, in MVOR-2, and COVID-19, reported in 4 of 121 (3.3%), 3 of 116 (2.6%), and 4 of 76 (5.3%) in MVOR-1 and 7 of 122 (5.7%), 8 of 121 (6.6%), and 5 of 82 (6.1%) in MVOR-2.
In this study, DFD-29 was superior in efficacy to both doxycycline and placebo and demonstrated a favorable risk-benefit profile in the treatment of PPR.
ClinicalTrials.gov Identifiers: NCT05296629 and NCT05343455.

Efficacy, Safety, and Tolerability of Oral DFD-29, a Low-Dose Formulation of Minocycline, in Rosacea: Two Phase 3 Randomized Clinical Trials.

Efficacy, Safety, and Tolerability of Oral DFD-29, a Low-Dose Formulation of Minocycline, in Rosacea

<jats:sec><jats:title>Importance</jats:title><jats:p>Office-based phototherapy is cost-effective for psoriasis but difficult to access. Home-based phototherapy is patient preferred but has limited clinical data, particularly in patients with darker skin.</jats:p></jats:sec><jats:sec><jats:title>Objective</jats:title><jats:p>To compare the effectiveness of home- vs office-based narrowband UV-B phototherapy for psoriasis.</jats:p></jats:sec><jats:sec><jats:title>Design, Setting, and Participants</jats:title><jats:p>The Light Treatment Effectiveness study was an investigator-initiated, pragmatic, open-label, parallel-group, multicenter, noninferiority randomized clinical trial embedded in routine care at 42 academic and private clinical dermatology practices in the US. Enrollment occurred from March 1, 2019, to December 4, 2023, with follow-up through June 2024. Participants were 12 years and older with plaque or guttate psoriasis who were candidates for home- and office-based phototherapy.</jats:p></jats:sec><jats:sec><jats:title>Interventions</jats:title><jats:p>Participants were randomized to receive a home narrowband UV-B machine with guided mode dosimetry or routine care with office-based narrowband UV-B for 12 weeks, followed by an additional 12-week observation period.</jats:p></jats:sec><jats:sec><jats:title>Main Outcomes and Measures</jats:title><jats:p>The coprimary effectiveness outcomes were Physician Global Assessment (PGA) dichotomized as clear/almost clear skin (score of ≤1) at the end of the intervention period and Dermatology Life Quality Index (DLQI) score of 5 or lower (no to small effect on quality of life) at week 12.</jats:p></jats:sec><jats:sec><jats:title>Results</jats:title><jats:p>Of 783 patients enrolled (mean [SD] age, 48.0 [15.5] years; 376 [48.0%] male), 393 received home-based phototherapy and 390 received office-based phototherapy, with 350 (44.7%) having skin phototype (SPT) I/II,  350 (44.7%) having SPT III/IV, and 83 (10.6%) having SPT V/VI. A total of 93 patients (11.9%) were receiving systemic treatment. At baseline, mean (SD) PGA was 2.7 (0.8) and DLQI was 12.2 (7.2). At week 12, 129 patients (32.8%) receiving home-based phototherapy and 100 patients (25.6%) receiving office-based phototherapy achieved clear/almost clear skin, and 206 (52.4%) and 131 (33.6%) achieved DLQI of 5 or lower, respectively. Home-based phototherapy was noninferior to office-based phototherapy for PGA and DLQI in the overall population and across all SPTs. Home-based phototherapy, compared to office-based phototherapy, was associated with better treatment adherence (202 patients [51.4%] vs 62 patients [15.9%]; <jats:italic>P</jats:italic> &amp;amp;lt; .001), lower burden of indirect costs to patients, and more episodes of persistent erythema (466 of 7957 treatments [5.9%] vs 46 of 3934 treatments [1.2%]; <jats:italic>P</jats:italic> &amp;amp;lt; .001). Both treatments were well tolerated with no discontinuations due to adverse events.</jats:p></jats:sec><jats:sec><jats:title>Conclusions and Relevance</jats:title><jats:p>In this randomized clinical trial, home-based phototherapy was as effective as office-based phototherapy for plaque or guttate psoriasis in everyday clinical practice and had less burden to patients.</jats:p></jats:sec><jats:sec><jats:title>Trial Registration</jats:title><jats:p>ClinicalTrials.gov Identifier: <jats:ext-link xmlns:xlink="http://www.w3.org/1999/xlink" ext-link-type="uri" xlink:href="https://clinicaltrials.gov/study/NCT03726489">NCT03726489</jats:ext-link></jats:p></jats:sec>

Psoriasis and comorbid diseases: epidemiology.

Risk of myocardial infarction in patients with psoriasis.

Psoriasis and the risk of diabetes: a prospective population-based cohort study.

Prevalence of metabolic syndrome in patients with psoriasis: a population-based study in the United Kingdom.

J Invest Dermatol

Shared genetic risk factors and causal association between psoriasis and coronary artery disease.

Nat Commun

Cause-specific mortality in patients with severe psoriasis: a population-based cohort study in the U.K.

Objective measures of psoriasis severity predict mortality: a prospective population-based cohort study.

Psoriasis and mortality in the United States: data from the National Health and Nutrition Examination Survey.

Psoriasis.

Lancet

Long-term persistence of first-line biologics for patients with psoriasis and psoriatic arthritis in the French Health Insurance Database.

JAMA Dermatol

Patient-reported reasons for the discontinuation of commonly used treatments for moderate to severe psoriasis.

Drug survival of biologics in treating psoriasis: a meta-analysis of real-world evidence.

Sci Rep

Comparison of drug discontinuation, effectiveness, and safety between clinical trial eligible and ineligible patients in BADBIR.

Factors influencing patient preferences for phototherapy: a survey study.

Joint American Academy of Dermatology–National Psoriasis Foundation guidelines of care for the management and treatment of psoriasis with phototherapy.

Secukinumab demonstrates superiority over narrow-band ultraviolet B phototherapy in new-onset moderate to severe plaque psoriasis patients: week 52 results from the STEPIn study.

J Eur Acad Dermatol Venereol

Incidence and profile of skin cancers in patients following ultraviolet phototherapy without psoralens: a retrospective cohort study.

Carcinogenic risks of psoralen UV-A therapy and narrowband UV-B therapy in chronic plaque psoriasis: a systematic literature review.

Effect of 2 psoriasis treatments on vascular inflammation and novel inflammatory cardiovascular biomarkers: a randomized placebo-controlled trial.

Circ Cardiovasc Imaging

Patient-reported outcomes of adalimumab, phototherapy, and placebo in the Vascular Inflammation in Psoriasis Trial: a randomized controlled study.

Systematic review and estimated cost-efficacy of biologics compared with narrowband ultraviolet B light for the treatment of moderate to severe psoriasis and atopic dermatitis.

Int J Dermatol

The pipeline and market for psoriasis drugs.

Nat Rev Drug Discov

Role of phototherapy in the era of biologics.

The PRECIS-2 tool: designing trials that are fit for purpose.

Patient-reported outcomes for psoriasis patients with clear versus almost clear skin in the clinical setting.

Translating the science of quality of life into practice: what do Dermatology Life Quality Index scores mean?

Validity of the Simple-Measure for Assessing Psoriasis Activity (S-MAPA) for objectively evaluating disease severity in patients with plaque psoriasis.

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J Clin Pharm Ther

Head-to-head trials of systemic psoriasis therapies: a systematic review of study design and maximum acceptable treatment differences.

Home versus outpatient ultraviolet B phototherapy for mild to severe psoriasis: pragmatic multicentre randomised controlled non-inferiority trial (PLUTO study).

Racial and ethnic diversity of US participants in clinical trials for acne, atopic dermatitis, and psoriasis: a comprehensive review.

J Dermatolog Treat

Systemic pharmacological treatments for chronic plaque psoriasis: a network meta-analysis.

Effect of availability of at-home phototherapy on the use of systemic medications for psoriasis.

Photodermatol Photoimmunol Photomed

Home narrowband UV-B treatment for psoriasis: a cohort study.

Systematic review of UV-based therapy for psoriasis.

Am J Clin Dermatol

Prescribing patterns associated with biologic therapies for psoriasis from a United States medical records database.

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Int J Immunopathol Pharmacol

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Duration of remission period of narrowband ultraviolet B therapy on psoriasis vulgaris.

J Dermatol

Office-based phototherapy is cost-effective for psoriasis but difficult to access. Home-based phototherapy is patient preferred but has limited clinical data, particularly in patients with darker skin.
To compare the effectiveness of home- vs office-based narrowband UV-B phototherapy for psoriasis.
The Light Treatment Effectiveness study was an investigator-initiated, pragmatic, open-label, parallel-group, multicenter, noninferiority randomized clinical trial embedded in routine care at 42 academic and private clinical dermatology practices in the US. Enrollment occurred from March 1, 2019, to December 4, 2023, with follow-up through June 2024. Participants were 12 years and older with plaque or guttate psoriasis who were candidates for home- and office-based phototherapy.
Participants were randomized to receive a home narrowband UV-B machine with guided mode dosimetry or routine care with office-based narrowband UV-B for 12 weeks, followed by an additional 12-week observation period.
The coprimary effectiveness outcomes were Physician Global Assessment (PGA) dichotomized as clear/almost clear skin (score of ≤1) at the end of the intervention period and Dermatology Life Quality Index (DLQI) score of 5 or lower (no to small effect on quality of life) at week 12.
Of 783 patients enrolled (mean [SD] age, 48.0 [15.5] years; 376 [48.0%] female), 393 received home-based phototherapy and 390 received office-based phototherapy, with 350 (44.7%) having skin phototype (SPT) I/II, 350 (44.7%) having SPT III/IV, and 83 (10.6%) having SPT V/VI. A total of 93 patients (11.9%) were receiving systemic treatment. At baseline, mean (SD) PGA was 2.7 (0.8) and DLQI was 12.2 (7.2). At week 12, 129 patients (32.8%) receiving home-based phototherapy and 100 patients (25.6%) receiving office-based phototherapy achieved clear/almost clear skin, and 206 (52.4%) and 131 (33.6%) achieved DLQI of 5 or lower, respectively. Home-based phototherapy was noninferior to office-based phototherapy for PGA and DLQI in the overall population and across all SPTs. Home-based phototherapy, compared to office-based phototherapy, was associated with better treatment adherence (202 patients [51.4%] vs 62 patients [15.9%]; P < .001), lower burden of indirect costs to patients, and more episodes of persistent erythema (466 of 7957 treatments [5.9%] vs 46 of 3934 treatments [1.2%]; P < .001). Both treatments were well tolerated with no discontinuations due to adverse events.
In this randomized clinical trial, home-based phototherapy was as effective as office-based phototherapy for plaque or guttate psoriasis in everyday clinical practice and had less burden to patients.
ClinicalTrials.gov Identifier: NCT03726489.

Home- vs Office-Based Narrowband UV-B Phototherapy for Patients With Psoriasis: The LITE Randomized Clinical Trial.

Home- vs Office-Based Narrowband UV-B Phototherapy for Patients With Psoriasis

Journal of the American Academy of Dermatology

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Pfizer

Utility of azathioprine, methotrexate and cyclosporine as steroid-sparing agents in chronic alopecia areata: a retrospective study of continuation rates in 138 patients

Killing two birds with one stone: oral tofacitinib reverses alopecia universalis in a patient with plaque psoriasis

Lymphocytes, neuropeptides, and genes involved in alopecia areata

J Clin Invest

Alopecia areata is driven by cytotoxic T lymphocytes and is reversed by JAK inhibition

Nat Med

Two phase 3 trials of baricitinib for alopecia areata

N Engl J Med

Ruxolitinib cream for the treatment of patients with alopecia areata: a 2-part, double-blind, randomized, vehicle-controlled phase 2 study

A phase 2a randomized vehicle-controlled multi-center study of the safety and efficacy of delgocitinib in subjects with moderate-to-severe alopecia areata

Arch Dermatol Res

Tofacitinib 2% ointment, a topical Janus kinase inhibitor, for the treatment of alopecia areata: a pilot study of 10 patients

Cardiovascular and cancer risk with tofacitinib in rheumatoid arthritis

A review of safety outcomes from clinical trials of baricitinib in rheumatology, dermatology and COVID-19

Less is more? Failure of one JAK inhibitor does not predict failure of another one in a patient with alopecia areata

Dermatol Ther

Development of the alopecia areata scale for clinical use: results of an academic-industry collaborative effort

Combination tofacitinib and oral minoxidil treatment for severe alopecia areata

Janus kinase (JAK) inhibitors have ushered in a new era in alopecia areata (AA). Historically, moderate-to-severe AA was refractory to treatment. JAK inhibitors have changed that; now, treatment of moderate-to-severe AA is possible. Here, we briefly review the history of and rationale for JAK inhibitor treatment of AA, phase 3 clinical trial data, and considerations regarding differences among JAK inhibitors, safety, and patient selection.

Janus kinase inhibitors for alopecia areata.

Janus kinase inhibitors for alopecia areata

Papers