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Sponsor study identifier
interventional
64
1 country
1
Study Start
May 1, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
December 31, 2025
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Study Completion
May 1, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Background: Acne vulgaris is a chronic inflammatory condition primarily caused by Cutibacterium acnes, which disrupts skin homeostasis, thereby triggering immune responses and sebum metabolism. Dysbiosis is an imbalances in the skin and gut microbiota identified as a significant factor contributing to acne progression. Standard therapy often rely on antibiotics, but the long-term use has increased antibiotic resistance, including in Indonesia. Consequently, alternative methods, such as probiotics and mesenchymal stromal cell (MSC) secretomes are gaining attention for immunomodulatory and regenerative properties. These novel therapies have shown promising results in modulating the skin and gut microbiota while reducing inflammation. Study Design: A phase 2 double-blind randomized controlled trial was adopted 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 mild to moderate acne vulgaris patients were randomly allocated to these groups. Interventions were administered over a period of 8 weeks, with outcomes measured at baseline and post-therapy. This study was conducted at Dermatology and Venereology Department of Bali Mandara General Hospital (RSBM). The primary outcome is the reduction of comedones and inflammatory lesions, assessed using the Yolov8 method. Secondary outcomes 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. Discussion: In the context of increasing antibiotic resistance in Indonesia, where therapies often fail to produce sustainable clinical outcomes, this study showed the potential of combining probiotics and MSC secretomes as adjunctive therapies for acne vulgaris. Probiotics restored gut and skin microbiota balance, while MSC secretomes promoted immune modulation and tissue repair. The results of this study paved the way for innovative, non-antibiotic methods for acne management, addressing the need for sustainable and effective therapies amidst growing concerns over dysbiosis and antibiotic resistance.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
May 1, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
March 20, 2025
Actual (reported)April 13, 2025
Actual (reported)May 1, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
December 31, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
May 1, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Reduction of comedones and inflammatory lesions
The primary outcome measured in this study is the reduction in the number of comedones and/or inflammatory lesions (papules/pustules). This is assessed using the Yolov8 machine learning detection method, which enables accurate and objective quantification of comedones and lesions while also determining the severity of acne
From enrollment to the end of treatment at 8 weeks
Tryptophan metabolites
From enrollment to the end of treatment at 8 weeks
Inflammatory Response
From enrollment to the end of treatment at 8 weeks
Collagen Measurement
From enrollment to the end of treatment at 8 weeks
Moisture content
From enrollment to the end of treatment at 8 weeks
Sebum levels
From enrollment to the end of treatment at 8 weeks
Standard therapy + oral probiotics + topical secretome (placebo)
Standard therapy + oral probiotics (placebo) + topical secretome
The standard therapy for participants included a structured skincare regimen. A face wash was used once daily before bedtime to cleanse the skin. In the morning, a non-comedogenic sunscreen and a moisturizer were applied to protect and hydrate the skin. Additionally, a night cream containing clindamycin and tretinoin was applied once daily at night, specifically on acne-affected areas, to target inflammation and promote skin renewal.
Rumah Sakit Umum Daerah Bali Mandara
Denpasar, Bali, 80116, Indonesia
Lestari K, Sutema IAMP, Latarissa IR, Oon SF, Tamsir NM, Noor A, Widowati IGAR, Sartika CR, Ciptasari NWE. Oral probiotics and topical secretome to enhance clinical outcomes and microbiome restoration in acne vulgaris: a double-blind, randomised controlled trial protocol. BMJ Open. 2026 Jun 4;16(6):e109586. doi: 10.1136/bmjopen-2025-109586.
First Submitted
March 20, 2025
First Posted
April 13, 2025
Standard therapy + oral probiotics + topical secretome
Standard therapy + oral probiotics (placebo) + topical secretome (placebo)
The oral probiotics given are Hexbio®, an oral probiotic containing multiple beneficial bacterial strains, including Lactobacillus acidophilus BCMC® 12130, Lactobacillus casei BCMC® 12313, Lactobacillus lactis BCMC® 12451, Bifidobacterium bifidum BCMC®02290, Bifidobacterium longum BCMC® 02120, and Bifidobacterium infantis BCMC®02129. This probiotic was administered in granule form and swallowed directly. Participants consumed the probiotic twice daily, after breakfast and dinner, for eight weeks to support gut microbiome balance and potential skin health benefits.
The topical secretome used is a hydrogel-based serum containing secretome components, including cytokines, growth factors, exosomes, microvesicles, and cell differentiation factors. The serum is formulated with a hydrogel base consisting of xanthan gum, sclerotium gum, 1% alginate, 2% glycerin, 1% caprylyl glycol, and 96% aqua. It is applied after cleansing the face with a facial cleanser, twice daily, in the morning and evening, for eight weeks
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Study Start
May 1, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
December 31, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
May 1, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
April 13, 2025
Record last verified: 2025-04
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Source: ClinicalTrials.gov.
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