The 2026 protocol tests oral HEXBIO probiotics plus topical secretome serum as add-ons to standard acne care for mild-to-moderate acne. Secretome here means a serum carrying factors released by mesenchymal stromal cells, not live cells. BMJ Open published the phase 2 double-blind randomized protocol on June 4 2026 as the BMJ Open protocol description. Adults with persistent acne should read it as a test plan, not proof of benefit.
Medical information disclaimer: This article is for general educational purposes only and does not provide medical advice, diagnosis, or treatment. Always consult a physician or other qualified health professional about symptoms, medications, tests, or treatment decisions.
Table of Contents
- What does the combination include?
- Who is studied and for how long?
- How will benefit be judged?
- What should adults with persistent acne do now?
What does the combination include?
The trial uses four parallel arms. Each participant receives an oral capsule and a topical serum, active or matched placebo. The oral product is HEXBIO. It contains Lactobacillus acidophilus BCMC 12130, L. casei BCMC 12313, L.
lactis BCMC 12451, Bifidobacterium bifidum BCMC 02290, B. longum BCMC 02120 and B. infantis, plus topical mesenchymal-stromal-cell secretome serum. Every group also uses the same standard care. That care is structured skincare plus once-nightly clindamycin-tretinoin cream on acne areas, so the trial tests added benefit.
- oral probiotic plus active secretome serum
- oral probiotic plus placebo serum
- oral placebo plus active secretome serum
- oral placebo plus placebo serum
Who is studied and for how long?
The plan enrolls 64 male and female patients with mild-to-moderate acne vulgaris. Treatment lasts 8 weeks in the dermatology department at Bali Mandara General Hospital. Acne, microbiome and skin measures are taken at baseline and after therapy.
The short window suits early signal detection, not long-term control. Persistent adult acne often lasts months or years and fluctuates with hormones, stress and products. An 8-week study in mild-to-moderate disease cannot stand in for that course.
How will benefit be judged?
The registered primary outcome is reduction in comedones and inflammatory lesions assessed by Yolov8 image analysis, according to the Veeva trial record from Universitas Padjadjaran. Image analysis gives a consistent lesion count across visits. Secondary measures include faecal microbiome, tryptophan metabolites, sebum, moisture, pH, collagen and IL-6.
Those tests link skin change to gut bacteria, skin barrier and inflammation. For readers, the key split is clinical versus explanatory. Lesion counts decide whether the add-on helped, while the other measures suggest how it might have acted.
What should adults with persistent acne do now?
This is protocol NCT06925386, listed as not yet enrolling, with short follow-up in mild-to-moderate disease. It therefore proves no efficacy or long-term result for persistent adult acne yet. Investigators cite antibiotic-resistance concerns in Indonesia as one reason to study non-antibiotic add-ons, according to the ICH GCP registry entry.
That context matters, but it does not make probiotics or secretome a substitute for proven care. Discuss any probiotic-secretome use as an add-on with a dermatologist and continue proven therapy. Bring your current prescriptions and skincare list to that visit and keep using them until your dermatologist advises a change.
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