The Relationship Between Microbioma Balance and Acne Vulgaris as a New Acne Treatment
Launched by UNIVERSITAS PADJADJARAN · Apr 6, 2025
Trial Information
Current as of June 26, 2025
Not yet recruiting
Keywords
ClinConnect Summary
This clinical trial is studying a new approach to treating acne vulgaris, a common skin condition that many people face. Researchers want to understand how balancing the bacteria in our skin and gut can help reduce acne. Instead of using antibiotics, which can lead to resistance and may not work for everyone, the trial is exploring the use of probiotics (good bacteria) and secretomes from special cells that can help heal the skin. The goal is to see if these treatments can effectively improve acne symptoms while also promoting overall skin and gut health.
To participate in this study, individuals aged 13 to 45 with mild to moderate acne are needed. Participants should have experienced new acne lesions in the past six months and must be in generally good health. They will receive different combinations of standard treatments along with probiotics and secretomes over an 8-week period. Throughout the trial, participants will have their skin health monitored and documented through photos. This research aims to provide new, non-antibiotic options for managing acne, which is especially important given the rising concerns about antibiotic use.
Gender
ALL
Eligibility criteria
- 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
About Universitas Padjadjaran
Universitas Padjadjaran, a prestigious academic institution in Indonesia, is dedicated to advancing medical research and clinical trials that contribute to the improvement of healthcare outcomes. With a strong emphasis on interdisciplinary collaboration and innovation, the university harnesses its extensive resources and expertise to conduct rigorous studies aimed at addressing pressing health challenges. Through its commitment to ethical research practices and community engagement, Universitas Padjadjaran plays a pivotal role in fostering evidence-based medicine and enhancing the quality of life for diverse populations.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Denpasar, Bali, Indonesia
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported