Evidence map›Paper›PMID 35861908›Full record

ArticleDermatology and therapy2022

A Randomized, Double-Blind, Placebo-Controlled, Multicentric Study to Evaluate the Efficacy and the Tolerability of a Class II Medical Device in the Treatment of Mild and Moderate Acne.

Gabriella Fabbrocini, Maria Ferrillo, Marianna Donnarumma, Angela Papale, Daniela Pinto, Fabio Rinaldi

Open access · goldAbstract read
In one paragraph

Article in Dermatology and therapy, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
0.8field-weighted citation impact, top 26% 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

2 citing papers in PubMed, 4 citations in OpenAlex.

  1. Cosmetic Interventions for Skin Microbiome Modulation: Current Strategies and Future Directions.Skin research and technology : official journal of International Society for Bioengineering and the Skin (ISBS) [and] International Society for Digital Imaging of Skin (ISDIS) [and] International Society for Skin Imaging (ISSI) · 2026
    Review
  2. Article
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

6 authors at 2 institutions in 1 country.

Gabriella FabbrociniDepartment of Clinical Medicine and Surgery, Section of Dermatology, University Hospital Federico II of Naples, Naples, Italy.
Maria FerrilloDepartment of Clinical Medicine and Surgery, Section of Dermatology, University Hospital Federico II of Naples, Naples, Italy.
Marianna DonnarummaDepartment of Clinical Medicine and Surgery, Section of Dermatology, University Hospital Federico II of Naples, Naples, Italy.
Angela PapaleHMAP, Human Microbiome Advanced Project, Via Pelagio Palagi, 2, 20129, Milan, Italy.
Daniela PintoHMAP, Human Microbiome Advanced Project, Via Pelagio Palagi, 2, 20129, Milan, Italy.
Fabio RinaldiHMAP, Human Microbiome Advanced Project, Via Pelagio Palagi, 2, 20129, Milan, Italy. FRinaldi@giulianipharma.com.ORCID http://orcid.org/0000-0002-8645-1720
Federico II University Hospital · ITGiuliani (Italy) · IT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionSeveral options are available to treat acne lesions, including topical benzoyl peroxide, topical retinoids, topical antibiotics, oral antibiotics, hormonal therapy, isotretinoin, and procedural therapies, such as light and laser therapies, although these cause side effects. This study aimed to establish the efficacy and tolerability of a class IIa medical device containing lactic acid, azelaic acid/polyglyceryl-3 copolymer, azelamidopropyl dimethyl amine, and bifida ferment lysate for the treatment of mild and moderate acne lesions.

methodsA randomized, double-blind, placebo-controlled, multicentric study was carried out in which 60 persons of both genders aged ≥ 16 years affected by mild or moderate acne were enrolled. Each person used the product twice daily for 2 months. The clinical score (classified as absent, mild, moderate, and severe) of lesions such as blackheads, whiteheads, papules and pustules, erythema, desquamation, sebum secretion, and porphyrins production by a wood lamp was evaluated on the basis of a dermatologist's visual assessment at baseline (t

resultsSixty subjects concluded the trial. It was observed that subjects treated with the medical device (group I) showed overall improvement in the analyzed acne lesions compared with placebo (group II) after 2 months of treatment. The efficacy of the treatment was also expressed as partial and total clearance. The medical device produced higher percentages of both partial and total clearance in all analyzed parameters, compared with the placebo group. The study was safe and well tolerated.

conclusionsIt was observed that the participants showed an overall improvement of the analyzed lesions in comparison with the placebo group, without adverse events during the trial. Hence, the medical device was found to be safe and effective in the treatment of mild or moderate acne.

Indexed as

Azelaic acid/polyglyceryl-3 copolymerAzelamidopropyl dimethyl amineBifida ferment lysateLactic acidMild acneModerate acne

Identifiers

PMID35861908
PMCPMC9357589
OpenAlexW4286111516

What Socratic holds

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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 Socratic graph.