NCT06925386NOT YET RECRUITINGPhase 2Background: 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.
No linked publications found in PubMed
Inclusion Criteria: * individuals aged 13 to 45 years * diagnosed with acne vulgaris by a certified dermatologist, presenting with mild to moderate facial acne based on the lesion count criteria by Lehman et al. Mild acne is defined as having fewer than 20 comedones or fewer than 15 papular/pustular lesions, while moderate acne is characterized by 20-100 comedones and 20-50 papular/pustular lesions. * must have experienced recurring new acne lesions in the past 6 months * must be willing to comply with all protocol requirements * must be willing to have standardized facial photograps taken using an imaging system * must be able to follow study and adhere to a fixed schedule * must have ability to provide inform concent for participation in the study * must be generally healthy and in good mental condition. Exclusion Criteria: * pregnant patients * subjects who have undergone hormonal acne treatment within six months prior to the study * subjects who have taken oral isotretinoin within one month prior to the study. * simultaneous participation in a different study conducted by an external research institution at the same testing site. * inadequate language proficiency (both spoken and written) * participation in the study under the influence of alcohol and/or drugs, as well as substance addiction * severe diseases (cardiovascular, hepatic, renal, or pulmonary diseases, severe diabetes mellitus) or chronic infections (Hepatitis, HIV). * immunodeficiency. * current use of the following topical or systemic medications: corticosteroids, immunosuppressants, and antihistamines. * skin conditions such as vitiligo, psoriasis, or atopic dermatitis. * any other diseases or medications that may directly interfere with the study or pose a risk to the subject's health