Oral probiotics and topical secretome in acne vulgaris: a double-blind RCT protocol
This paper describes a phase 2 RCT protocol to test oral probiotics and topical mesenchymal stromal cell secretome as adjuncts to standard acne therapy — no results have been generated yet.
Context
Acne vulgaris involves skin and gut dysbiosis, and rising antibiotic resistance has prompted investigation of immunomodulatory alternatives such as probiotics and cell-derived secretomes.
What the study showed
The abstract reports no efficacy or safety data — it is solely a study protocol. The design includes four parallel arms evaluating oral probiotic, topical secretome, their combination, and dual placebo, all on top of standard therapy. Outcomes will be assessed at baseline and after 8 weeks.
How it was done
Phase 2 double-blind RCT with parallel-group design, four arms, n=64 patients with mild to moderate acne vulgaris, 8-week intervention.
Limitations
No outcome data are available; this assessment is based solely on the protocol abstract. A sample of 64 participants is small and may lack statistical power for microbiome subgroup analyses.
In clinical practice
No clinical practice change is supported by this protocol. Results, once published, may provide phase 2 evidence on adjunctive probiotic and secretome use in acne.
