Evidence map›Paper›PMID 31907924›Full record

Trial reportThe British journal of dermatology2020

A multicentre, randomized, double-masked, parallel group, vehicle-controlled phase IIb study to evaluate the safety and efficacy of 1% and 3% topical minocycline gel in patients with papulopustular rosacea.

G Webster, Z D Draelos, E Graber, M S Lee, S Dhawan, M Salman, G N Magrath

Open access · hybridAbstract readClinical Trial, Phase IIMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in The British journal of dermatology, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 14 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
14citing papers in PubMed, 3 pooled it
2.3field-weighted citation impact, top 11% of its field
1 · What the graph read from 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.

2 · The registry

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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

14 citing papers in PubMed, 3 syntheses or guidelines pooled it, 28 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Article
  5. Review
  6. Article
  7. Review
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  9. Review
  10. Review
  11. Rosacea: New Concepts in Classification and Treatment.American journal of clinical dermatology · 2021
    Review
  12. Review
  13. Rosacea Treatment: Review and Update.Dermatology and therapy · 2021
    Review
  14. Rosacea: Pathogenesis and Therapeutic Correlates.Journal of cutaneous medicine and surgery
    Review
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

7 authors at 5 institutions in 1 country.

G WebsterDepartment of Dermatology, Sidney Kimmel Medical College of Thomas Jefferson University, Philadelphia, PA, USA.
Z D DraelosDermatology Consulting Services, High Point, NC, USA.
E GraberNortheastern University and The Dermatology Institute of Boston, Boston, MA, USA.
M S LeeLee Medical Associates, San Antonio, TX, USA.
S DhawanCenter for Dermatology, Cosmetic, and Laser Surgery, Freemont, CA, USA.
M SalmanHovione Scientia Ltd., Loughbeg, Ringaskiddy, Cork, Ireland.
G N MagrathHovione Scientia Ltd., Loughbeg, Ringaskiddy, Cork, Ireland.
Center for Dermatology, Cosmetic & Laser Surgery · USDermatology Consulting Services · USMedical University of South Carolina · USNortheastern University · USThomas Jefferson University · US

Funding

Hovione Scientia Ltd.
6 · The paper itself

Abstract

backgroundPapulopustular rosacea is characterized by chronic facial erythema and inflammatory facial lesions. Minocycline has anti-inflammatory properties which may be effective in the treatment of rosacea inflammatory lesions.

objectivesTo assess the safety and efficacy of once-daily topical minocycline gel 1% and 3% in patients with papulopustular rosacea.

methodsThis was a prospective, 12-week, double-blinded study conducted at 26 sites in the United States; 270 patients with papulopustular rosacea and 12-40 inflammatory lesions were randomized to minocycline 1%, minocycline 3% or vehicle. The primary endpoint was the mean change in inflammatory lesions at week 12. Key secondary endpoints included success on an Investigator's Global Assessment (IGA).

resultsBaseline mean lesion counts were 24·6, 25·1 and 24·3 in the minocycline 1%, minocycline 3% and vehicle groups, respectively; at week 12, the counts had decreased by 12·6, 13·1 and 7·9, respectively. Minocycline significantly decreased lesions, compared with the vehicle [P = 0·01, 95% confidence interval (CI) 7·9 to 0·9, for minocycline 1%; P = 0·007, 95% CI 8·3 to 1·3, for minocycline 3%]. The proportion of patients achieving IGA success was 39% in the minocycline 1% arm [P = 0·34, odds ratio (OR) 1·396 and OR 95% CI 0·71 to 2·75 vs. vehicle], 46% in the minocycline 3% arm (P = 0·04, OR 2·03 and OR 95% CI 1·04 to 3·95 vs. vehicle) and 31% in the vehicle arm.

conclusionsMinocycline topical gel appears to be safe and tolerable at concentrations of 1% and 3%, and both concentrations significantly decreased inflammatory lesion counts, with a significantly larger proportion of patients achieving IGA success at week 12 in the minocycline 3% arm. These findings support further evaluation of minocycline gel for treating inflammatory lesions associated with papulopustular rosacea. Linked Comment: Hampton. Br J Dermatol 2020; 183:412-413.

Indexed as

Dermatologic AgentsRosaceaAdministration, CutaneousDouble-Blind MethodHumansMinocyclineProspective StudiesTreatment OutcomeUnited StatesDermatologic AgentsMinocycline

Identifiers

PMID31907924
PMCPMC7496252
OpenAlexW3000511935

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
Read underepoch 390

Registered trials

None linked

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.