Evidence map›Paper›PMID 42242743›Full record

ArticleBMJ open2026

Oral probiotics and topical secretome to enhance clinical outcomes and microbiome restoration in acne vulgaris: a double-blind, randomised controlled trial protocol.

Keri Lestari, Ida Ayu Manik Partha Sutema, Irma Rahayu Latarissa, Seok Fang Oon, Norain Mohd Tamsir, Aida Noor, I Gusti Ayu Rai Widowati, Cynthia Retna Sartika, Ni Wayan Eka Ciptasari

Registry-linked trialAbstract readClinical Trial Protocol
In one paragraph

Article in BMJ open, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06925386 (The Relationship Between Microbioma Balance and Acne Vulgaris as a New Acne Treatment), which is not on this map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing 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.

NCT06925386 phase2not yet recruitingnot on this map

The Relationship Between Microbioma Balance and Acne Vulgaris as a New Acne Treatment

TypeinterventionalSponsorUniversitas PadjadjaranRan2025 to 2026Enrolled64ConditionsAcne VulgarisArmsStandard therapy, HEXBIO, Secretome
3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

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.

Keri LestariDepartment of Pharmacology and Clinical Pharmacy, Universitas Padjadjaran, Sumedang, West Java, Indonesia lestarikd@unpad.ac.id.ORCID http://orcid.org/0000-0002-2099-1062
Ida Ayu Manik Partha SutemaDepartment of Pharmacology and Clinical Pharmacy, Universitas Padjadjaran, Sumedang, West Java, Indonesia.
Irma Rahayu LatarissaDepartment of Pharmacology and Clinical Pharmacy, Universitas Padjadjaran, Sumedang, West Java, Indonesia.
Seok Fang OonDepartment of Medical Affairs, B-Crobes Laboratory, Ipoh, Perak, Malaysia.
Norain Mohd TamsirDepartment of Medical Affairs, B-Crobes Laboratory, Ipoh, Perak, Malaysia.
Aida NoorDepartment of Medical Affairs, B-Crobes Laboratory, Ipoh, Perak, Malaysia.
I Gusti Ayu Rai WidowatiClinical Pharmacy Study Program, Bali International University, Denpasar, Bali, Indonesia.
Cynthia Retna SartikaDepartment of Pharmacology and Clinical Pharmacy, Universitas Padjadjaran, Sumedang, West Java, Indonesia.
Ni Wayan Eka CiptasariNgoerah Sun Wellness and Aesthetic Center, Prof. Dr. I.G.N.G. Ngoerah Central General Hospital, Denpasar, Bali, Indonesia.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundAcne vulgaris is a chronic inflammatory condition primarily caused by METHODS AND ANALYSIS: A phase 2 double-blind randomised controlled trial will be conducted using a parallel group design with four arms, namely: (1) standard therapy with oral probiotics and topical secretome (placebo), (2) standard therapy with oral probiotics (placebo) and topical secretome, (3) standard therapy with oral probiotics and topical secretome and (4) standard therapy with oral probiotics (placebo) and topical secretome (placebo). Sixty-four patients with mild to moderate acne vulgaris will be randomly allocated to these groups. Interventions will be administered over a period of 8 weeks, with outcomes to be measured at baseline and post-therapy. This study will be conducted at the Dermatology and Venereology Department of Bali Mandara General Hospital (RSBM). The primary outcome will be the reduction of comedones and inflammatory lesions, assessed using the Yolov8 method. Secondary outcomes will include gut and skin health parameters, such as tryptophan metabolites, collagen, pH, moisture, sebum levels and IL-6, to explore the relationship between microbiome balance, skin condition and inflammation in acne. ETHICS AND DISSEMINATION: This study will be conducted in accordance with the ethical principles outlined in the Declaration of Helsinki and the International Conference on Harmonisation-Good Clinical Practice guidelines. Ethical approval has been granted by the Health Research Ethics Committee of Bali Mandara Regional Hospital (Approval Reference Number: 060/EA/KEPK.RSBM.DINKES/2024). All participants will provide written informed consent prior to enrolment. Data confidentiality and participant safety will be upheld throughout the trial. The results of this study will be disseminated through journals, scientific conferences and relevant academic platforms to ensure wide accessibility and to support further research and clinical application in the field of dermatology, particularly in addressing antibiotic resistance and microbiome-based acne therapies. TRIAL REGISTRATION NUMBER: NCT06925386.

Indexed as

Acne VulgarisGastrointestinal MicrobiomeProbioticsAdministration, OralAdministration, TopicalClinical Trials, Phase II as TopicDouble-Blind MethodHumansIndonesiaRandomized Controlled Trials as TopicSkin MicrobiomeTreatment OutcomeAcneClinical TrialGastrointestinal Microbiome

Identifiers

PMID42242743
PMCPMC13239365

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.