Evidence map›Paper›PMID 37636253›Full record

ArticleThe Journal of clinical and aesthetic dermatology2023

Efficacy and Safety of Microencapsulated Benzoyl Peroxide Cream, 5%, in Rosacea: Results From Two Phase III, Randomized, Vehicle-Controlled Trials.

Neal D Bhatia, Wm Philip Werschler, Hilary Baldwin, Jeffrey Sugarman, Lawrence J Green, Ofra Levy-Hacham, Ori Nov, Vered Ram, Linda Stein Gold

2 registry-linked trialsAbstract read
In one paragraph

Article in The Journal of clinical and aesthetic dermatology, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 9 papers.

0numbers the graph read from it
0cells of the map it votes in
9citing papers in PubMed
–field-weighted citation impact
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.

NCT03448939 phase3completednot on this map

A Phase 3 Multi-Center, Double-Blind, Randomized, Vehicle-Controlled Study of S5G4T-1 in the Treatment of Papulopustular Rosacea

TypeinterventionalSponsorSol-Gel Technologies, Ltd.Ran2018 to 2019Enrolled361ConditionsPapulopustular RosaceaArmsS5G4T-1, S5G4T-2
NCT03564119 phase3completednot on this map

A Phase 3 Multi-Center, Double-Blind, Randomized, Vehicle-Controlled Study of S5G4T-1 in the Treatment of Papulopustular Rosacea

TypeinterventionalSponsorSol-Gel Technologies, Ltd.Ran2018 to 2019Enrolled372ConditionsPapulopustular RosaceaArmsS5G4T-1, S5G4T-2
3 · Its place in the literature

Who cites it

9 citing papers in PubMed.

  1. Review
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

9 authors.

Neal D BhatiaDr. Bhatia is with Therapeutics Clinical Research in San Diego, California.
Wm Philip WerschlerDr. Werschler is with the University of Washington and Premier Clinical Research in Spokane, Washington.
Hilary BaldwinDr. Baldwin is with the Acne Treatment and Research Center in Brooklyn, New York, and the Rutgers Robert Wood Johnson Medical Center in New Brunswick, New Jersey.
Jeffrey SugarmanDr. Sugarman is with the University of California San Francisco in San Francisco, California.
Lawrence J GreenDr. Green is with the George Washington University School of Medicine in Washington, DC.
Ofra Levy-HachamDrs. Levy-Hacham and Nov are with Sol-Gel Technologies in Ness Ziona, Israel. Additionally, Ms. Ram is with Sol-Gel Technologies in Ness Ziona, Israel.
Ori NovDrs. Levy-Hacham and Nov are with Sol-Gel Technologies in Ness Ziona, Israel. Additionally, Ms. Ram is with Sol-Gel Technologies in Ness Ziona, Israel.
Vered RamDrs. Levy-Hacham and Nov are with Sol-Gel Technologies in Ness Ziona, Israel. Additionally, Ms. Ram is with Sol-Gel Technologies in Ness Ziona, Israel.
Linda Stein GoldDr. Stein Gold is with Henry Ford Health Systems in Detroit, Michigan.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Objective: A new formulation of benzoyl peroxide (E-BPO cream, 5%) entraps benzoyl peroxide (BPO) in silica microcapsules. This study assesses the efficacy, safety, and tolerability of E-BPO cream, 5%, in rosacea in two Phase III clinical trials. Methods: In two 12-week, randomized, double-blind, vehicle cream-controlled Phase III trials, 733 subjects at least 18 years old with moderate to severe rosacea were randomized (2:1) to once-daily E-BPO cream, 5%, or vehicle. Results: In Study 1, the proportion of subjects achieving IGA clear/almost clear at Week 12 was 43.5 percent for E-BPO cream, 5%, and 16.1 percent for vehicle. In Study 2, the respective values were 50.1 percent and 25.9 percent. In Study 1, the decrease in lesion count from baseline to Week 12 was -17.4 for E-BPO cream, 5%, versus -9.5 for vehicle. In Study 2, the respective values were -20.3 and -13.3 (all E-BPO was not compared with unencapsulated BPO. Conclusion: E-BPO is an effective and well tolerated treatment for rosacea. Clinicaltrials.gov Identifiers: NCT03564119, NCT03448939.

Indexed as

Benzoyl peroxideBPOmicroencapsulationpapulopustularrosaceatopical

Identifiers

PMID37636253
PMCPMC10452484

What OpenQuestion holds

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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.