ArticleThe Journal of clinical and aesthetic dermatology2021
Minocycline Extended-Release Comparison with Doxycycline for the Treatment of Rosacea: A Randomized, Head-to-Head, Clinical Trial.
Article in The Journal of clinical and aesthetic dermatology, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03340961 (A Multi-Center, Randomized, Double-Blind, Parallel-Group, Controlled Study to Assess the Efficacy, Safety and Tolerability of Oral DFD-29 Extended Release Capsules for the Treatment of Inflammatory Lesions of Rosacea Over 16 Weeks), which is not on this map. Cited by 9 papers, 1 of them a synthesis that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
A Multi-Center, Randomized, Double-Blind, Parallel-Group, Controlled Study to Assess the Efficacy, Safety and Tolerability of Oral DFD-29 Extended Release Capsules for the Treatment of Inflammatory Lesions of Rosacea Over 16 Weeks
Who cites it
9 citing papers in PubMed, 1 synthesis or guideline pooled it, 7 citations in OpenAlex.
- Efficacy of Treatments in Reducing Inflammatory Lesion Count in Rosacea: A Systematic Review.Journal of cutaneous medicine and surgeryPooled it
- Effect on the Skin Microbiota of Oral Minocycline for Rosacea.Acta dermato-venereologica · 2023Trial
- Rosacea in Patients with Skin of Color: Diagnosis and Management.American journal of clinical dermatology · 2026Review
- A novel presentation of minocycline-induced nail discoloration: A case report.Experimental and therapeutic medicine · 2026Article
- Impact of Oral DFD-29, a Low-Dose Formulation of Minocycline, on Quality of Life in Patients with Rosacea: Results of Two Phase 3 Randomized Controlled Trials.The Journal of clinical and aesthetic dermatology · 2025Article
- Therapeutic strategies focusing on immune dysregulation and neuroinflammation in rosacea.Frontiers in immunology · 2024Review
- Tetracyclines Revisited: Tetracyclines in the Field of Dermatology.Dermatology (Basel, Switzerland) · 2024Review
- Oral Tetracycline-Class Drugs in Dermatology: Impact of Food Intake on Absorption and Efficacy.Antibiotics (Basel, Switzerland) · 2023Review
- Rosacea pathogenesis and therapeutics: current treatments and a look at future targets.Frontiers in medicine · 2023Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
9 authors at 1 institution in 5 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
objectiveMinocycline efficacy for the treatment of papulopustular rosacea (PPR) has not been evaluated in clinical trials at levels demonstrated to stay below the antimicrobial threshold. We assessed the efficacy, safety, and dose response of DFD-29, a minocycline extended-release oral capsule. Two studies are reported (NCT03340961).
methodsA single-center open-label, three-arm, Phase I pharmacokinetic study randomized 24 healthy subjects aged 18 to 45 years to receive 21 days of once-daily dosing with DFD-29 40 or 20mg, or doxycycline 40mg. Blood samples were collected over 24 hours on Days 1 and 21 to plot mean plasma concentration levels. A multicenter Phase II clinical trial randomized 205 subjects with mild-to-severe PPR 1:1:1:1 to receive once-daily DFD-29 40 or 20mg, doxycycline 40mg, or placebo for 16 weeks. Co-primary endpoints were the proportion of subjects achieving treatment success (IGA grade 0 or 1 and ≥2-grade improvement) at Week 16, and a reduction in total inflammatory lesion count at Week 16.
resultsPharmacokinetic analysis demonstrated that minocycline plasma levels of DFD-29 40mg were approximately half those of doxycycline 40mg after 21 days, with DFD-29 20mg even lower, demonstrating a dose response. In the Phase II trial, DFD-29 40mg met both co-primary endpoints, achieving IGA treatment success in 66.0 percent subjects versus 11.5 percent placebo ( LIMITATIONS: MIC values and plasma concentrations shown for antibacterial threshold data are mean values; fast absorbers/slow metabolizers could exceed the threshold, causing resistance selection pressure.
conclusionDFD-29 40mg demonstrated significantly greater efficacy than placebo, DFD-29 20mg, and doxycycline 40mg at plasma concentrations predicted to be below the antimicrobial threshold for the treatment of PPR.
Indexed as
Identifiers
35096250PMC8794488W4210821458What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.