Journal of the American Academy of Dermatology

publisher

articletitle

journaltitle

articlelink

content_type

copyright

Doxycycline for central centrifugal cicatricial alopecia: a single center retrospective analysis

J Am Acad Dermatol

Successful treatment of epidermal growth factor receptor inhibitor-induced alopecia with doxycycline

JAAD Case Rep

Effects of subantimicrobial-dose doxycycline in the treatment of moderate acne

Arch Dermatol

Efficacy and tolerability of low-dose versus high-dose doxycycline in the management of lymphocytic scarring alopecias.

Efficacy and tolerability of low-dose versus high-dose doxycycline in the management of lymphocytic scarring alopecias

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

Recommendations for rosacea diagnosis, classification and management: update from the Global Rosacea Consensus 2019 Panel.

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.

J Immunol

Tetracyclines modulate protease-activated receptor 2-mediated proinflammatory reactions in epidermal keratinocytes.

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.

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

American Academy of Dermatology

The burden of skin disease in the United States

Magnitude and temporal trend of acne vulgaris burden in 204 countries and territories from 1990 to 2019: an analysis from the global burden of disease study 2019

Guidelines of care for the management of acne vulgaris

Evidence-based recommendations for the diagnosis and treatment of pediatric acne

Pediatrics

GRADE guidelines: 14. Going from evidence to recommendations: the significance and presentation of recommendations

J Clin Epidemiol

GRADE guidelines: 15. Going from evidence to recommendation-determinants of a recommendation's direction and strength

Guideline panels should seldom make good practice statements: guidance from the GRADE Working Group

Management of acne vulgaris: a review

The global burden of skin disease in 2010: an analysis of the prevalence and impact of skin conditions

J Invest Dermatol

Epidemiology of acne vulgaris

Global skin disease morbidity and mortality: an update from the global burden of disease study 2013

JAMA Dermatol

Recent findings in the epidemiologic evidence, classification, and subtypes of acne vulgaris

A qualitative investigation of the impact of acne on health-related quality of life (HRQL): development of a conceptual model

Dermatol Ther

Patient perspectives on the lived experience of acne and its treatment among adult women with acne: a qualitative study

The quality of life in acne: a comparison with general medical conditions using generic questionnaires

The quality of life impact of acne and rosacea compared to other major medical conditions

Depression and suicidal ideation in dermatology patients with acne, alopecia areata, atopic dermatitis and psoriasis

Experiences of appearance-related teasing and bullying in skin diseases and their psychological sequelae: results of a qualitative study

Scand J Caring Sci

Psychosocial judgements and perceptions of adolescents with acne vulgaris: a blinded, controlled comparison of adult and peer evaluations

Biopsychosoc Med

Acne, anxiety, depression and suicide in teenagers: a cross-sectional survey of New Zealand secondary school students

J Paediatr Child Health

Systematic review of the epidemiology of acne vulgaris

Sci Rep

Prioritizing treatment outcomes: how people with acne vulgaris decide if their treatment is working

J Evid Based Med

The Leeds revised acne grading system

J Dermatol Treat

A comparison of current acne grading systems and proposal of a novel system

Int J Dermatol

Development and evaluation of a global acne severity scale (GEA scale) suitable for France and Europe

J Eur Acad Dermatol Venereol

Development and validation of a comprehensive acne severity scale

J Cutan Med Surg

The patient-centered acne severity scale study

Pediatr Dermatol

Development and initial validation of a multidimensional acne global grading system integrating primary lesions and secondary changes

Analysis of trends and status of physician-based evaluation methods in acne vulgaris from 2000 to 2019

J Dermatol

Evolution of acne assessments and impact on acne medications: an evolving, imperfect paradigm

Evaluation of essential clinical components and features of current acne global grading scales

Acne severity grading: determining essential clinical components and features using a Delphi consensus

A provider global assessment quality measure for clinical practice for inflammatory skin disorders

Objective assessment of acne

Clin Dermatol

Quality of life measurement in acne. Position paper of the European Academy of Dermatology and Venereology task forces on quality of life and patient oriented outcomes and acne, rosacea and hidradenitis suppurativa

Quality-of-Life research in acne vulgaris: current status and future directions

Am J Clin Dermatol

Patient-reported outcome measures for health-related quality of life in patients with acne vulgaris: a systematic review of measure development and measurement properties

Propionibacterium acnes strain populations in the human skin microbiome associated with acne

Quantitative PCR of Propionibacterium acnes DNA in samples aspirated from sebaceous follicles on the normal skin of subjects with or without acne

J Med Dent Sci

Microorganisms inhabiting follicular contents of facial acne are not only Propionibacterium but also Malassezia spp

Differences of microbiomes found in non-inflammatory and inflammatory lesions of acne vulgaris

Clin Cosmet Investig Dermatol

Skin microbiome and acne vulgaris: staphylococcus, a new actor in acne

Exp Dermatol

Inferences in microbial structural signatures of acne microbiome and mycobiome

J Microbiol

Analysis of facial skin-resident microbiota in Japanese acne patients

Nasal antibiotic-resistant Propionibacterium acnes carriage in acne vulgaris patients in Turkey

Antimicrobial susceptibility and genetic characteristics of Propionibacterium acnes isolated from patients with acne

Hormonal and metabolic aspects of acne vulgaris in women with polycystic ovary syndrome

Eur Rev Med Pharmacol Sci

Association of serum testosterone and sex hormone binding globulin levels in females with acne based on its severity

J Ayub Med Coll Abbottabad

Evaluation and treatment of hirsutism in premenopausal women: an endocrine society clinical practice guideline

J Clin Endocrinol Metab

Assessment of androgens in women with adult-onset acne

Endocrine parameters in acne vulgaris

Endocrinol Exp

Plasma androgens in women with acne vulgaris

Hormonal profiles and prevalence of polycystic ovary syndrome in women with acne

The relationship of lipid profile and menstrual cycle with acne vulgaris

Clin Biochem

Changes in the hormone and lipid profile of obese adolescent Saudi females with acne vulgaris

Braz J Med Biol Res

Role of growth hormone and insulin-like growth factor-I in hyperandrogenism and the severity of acne vulgaris in young males

Saudi Med J

Novel tretinoin 0.05% lotion for the once-daily treatment of moderate-to-severe acne vulgaris: assessment of efficacy and safety in patients aged 9 years and older

J Drugs Dermatol JDD

Adapalene gel 0.3% for the treatment of acne vulgaris: a multicenter, randomized, double-blind, controlled, phase III trial

Tazarotene gel is safe and effective in the treatment of acne vulgaris: a multicenter, double-blind, vehicle-controlled study

Tazarotene 0.045% lotion for once-daily treatment of moderate-to-severe acne vulgaris: results from two phase 3 trials

Randomized phase 3 evaluation of trifarotene 50 mug/g cream treatment of moderate facial and truncal acne

Microencapsulated benzoyl peroxide and tretinoin for the treatment of acne vulgaris: results from a phase 2 multicenter, double-blind, randomized, vehicle-controlled study

Skinmed

Adapalene-benzoyl peroxide, a unique fixed-dose combination topical gel for the treatment of acne vulgaris: a transatlantic, randomized, double-blind, controlled study in 1670 patients

Is benzoyl peroxide 3% topical gel effective and safe in the treatment of acne vulgaris in Japanese patients? A multicenter, randomized, double-blind, vehicle-controlled, parallel-group study

Safety and efficacy of clindamycin phosphate 1.2%-benzoyl peroxide 3% fixed-dose combination gel for the treatment of acne vulgaris: a phase 3, multicenter, randomized, double-blind, active- and vehicle-controlled study

Benzoyl peroxide lotion (20 percent) in acne

A double-blind study of the effectiveness of a 3% erythromycin and 5% benzoyl peroxide combination in the treatment of acne vulgaris

Treatment of acne with a combination clindamycin/benzoyl peroxide gel compared with clindamycin gel, benzoyl peroxide gel and vehicle gel: combined results of two double-blind investigations

A double-blind evaluation of topical isotretinoin 0.05%, benzoyl peroxide gel 5% and placebo in patients with acne

Clin Exp Dermatol

Efficacy and safety of clindamycin-tretinoin gel versus clindamycin or tretinoin alone in acne vulgaris: a randomized, double-blind, vehicle-controlled study

Cortexolone 17alpha-propionate 1% cream, a new potent antiandrogen for topical treatment of acne vulgaris. A pilot randomized, double-blind comparative study vs. placebo and tretinoin 0.05% cream

Tazarotene 0.045% lotion for moderate-to-severe acne in male and female participants: a phase II post-hoc analysis

Tretinoin 0.05% lotion for the once-daily treatment of moderate-to-severe acne vulgaris: impact of gender and Race on efficacy and safety

Tazarotene 0.045% lotion for moderate-to-severe acne patients: pooled phase 3 analysis by age and sex

Tretinoin 0.05% lotion for the once-daily treatment of moderate and severe acne vulgaris in females: effect of age on efficacy and tolerability

Efficacy and safety of short term use of 0.1% tazarotene gel in the treatment of mild to moderate acne vulgaris: a randomized-vehicle controlled trial

J Postgrad Med Inst

Daily treatment with adapalene gel 0.1% maintains initial improvement of acne vulgaris previously treated with oral lymecycline

Eur J Dermatol

A placebo-controlled clinical trial to compare a gel containing a combination of isotretinoin (0.05%) and erythromycin (2%) with gels containing isotretinoin (0.05%) or erythromycin (2%) alone in the topical treatment of acne vulgaris

Dermatology (Basel, Switzerland)

A phase 2, multicenter, double-blind, randomized, vehicle-controlled clinical study to compare the safety and efficacy of a novel tazarotene 0.045% lotion and tazarotene 0.1% cream in the treatment of moderate-to-severe acne vulgaris

Efficacy of topical isotretinoin 0.05% gel in acne vulgaris: results of a multicenter, double-blind investigation

Efficacy and tolerability of a novel tretinoin 0.05% lotion for the once-daily treatment of moderate or severe acne vulgaris in adult females

Dapsone gel 5% for the treatment of acne vulgaris: safety and efficacy of long-term (1 year) treatment

Efficacy and safety of once-daily dapsone gel, 7.5% for treatment of adolescents and adults with acne vulgaris: second of two identically designed, large, multicenter, randomized, vehicle-controlled trials

Efficacy and safety of once-daily dapsone gel, 7.5% for treatment of adolescents and adults with acne vulgaris: first of two identically designed, large, multicenter, randomized, vehicle-controlled trials

BPX-01 minocycline topical gel shows promise for the treatment of moderate-tosevere inflammatory acne vulgaris

Efficacy and safety of a novel topical minocycline foam for the treatment of moderate to severe acne vulgaris: a phase 3 study

Erythromycin 2 percent gel in the treatment of acne vulgaris

Papers