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

NCT06925386 | Not Yet Recruiting Phase 2

• 1 other identifier: PHAR-202503.01
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Acne Vulgaris

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (6)

• 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

Study Arms (4)

Group 1

EXPERIMENTAL

Standard therapy + oral probiotics + topical secretome (placebo)

Drug: Standard therapy; Dietary Supplement: HEXBIO

Group 2

EXPERIMENTAL

Standard therapy + oral probiotics (placebo) + topical secretome

Drug: Standard therapy; Biological: Secretome

Group 3

EXPERIMENTAL

Standard therapy + oral probiotics + topical secretome

Drug: Standard therapy; Dietary Supplement: HEXBIO; Biological: Secretome

Group 4

PLACEBO COMPARATOR

Standard therapy + oral probiotics (placebo) + topical secretome (placebo)

Drug: Standard therapy

Interventions

Standard therapy DRUG

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.

Group 1; Group 2; Group 3; Group 4

HEXBIO DIETARY_SUPPLEMENT

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.

Group 1; Group 3

Secretome BIOLOGICAL

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

Group 2; Group 3

Eligibility Criteria

• Age: 13 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Universitas Padjadjaran: lead
• PT. Prodia Stem Cell Indonesia: collaborator
• B-Crobes Laboratory (M) Sdn Bhd: collaborator

Study Sites (1)

Rumah Sakit Umum Daerah Bali Mandara

Denpasar, Bali, 80116, Indonesia

Location

MeSH Terms

Conditions

Acne Vulgaris

Interventions

Standard of Care; Secretome

Condition Hierarchy (Ancestors)

Acneiform Eruptions; Skin Diseases; Skin and Connective Tissue Diseases; Sebaceous Gland Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation; Metabolome; Metabolism

Central Study Contacts

apt. Ida Ayu Manik Pharta Sutema, M.Farm., Researcher

CONTACT

+6282236350009; idaayumanik85@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A parallel group design with four arms was used, (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). Participants were assigned to groups using a random permuted block sampling method (comprising A, B, C, D). This method is commonly applied in clinical trials including small sample sizes with staggered participants' enrollment. Observation spans 8 weeks. All groups were subjected to pretest and posttest assessments, measuring acne severity, fecal microbiome metabolites, skin condition, and IL-6 before and after intervention.

Study Record Dates

• First Submitted: March 20, 2025
• First Posted: April 13, 2025
• Study Start: May 1, 2025
• Primary Completion: December 31, 2025
• Study Completion: May 1, 2026
• Last Updated: April 13, 2025

Record last verified: 2025-04

Locations

ID (1)