The Relationship Between Microbioma Balance and Acne Vulgaris as a New Acne Treatment
Tahapan Penelitian : Recruit
Sponsor:
PT Prodia StemCell Indonesia
Mitra Pelaksana:
Universitas Padjajaran, Bali Mandara Regional General Hospital
No Registry
INA-5D7L9036
Tanggal Input Registry : 04-06-2025
| Tracking Information | |
|---|---|
| Tanggal Antisipasi Studi | 01-05-2025 |
| Outcome Primer | Reduction of comedones and inflammatory lesions |
| Outcome Skunder | Tryptophan metabolites |
| Descriptive Information | |
| Judul Penelitian Popular | The Relationship Between Microbioma Balance and Acne Vulgaris as a New Acne Treatment |
| Judul Penelitian Ilmiah | The Relationship Between Microbioma Balance and Acne Vulgaris as a New Acne Treatment |
| Jenis Penelitian | Interventional |
| Intervensi | Drug : Standard therapy, Dietary Supplement : HEXBIO, Biological : Secretome |
| Jumlah Subyek Penelitian | 64 |
| Recruitment Information | |
| 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 |
| Administrative Information | |
| Nomor Persetujuan Etik | 0460/UN14.2.2.VII.14/LT/2024 |
| Nomor Persetujuan Material Transfer Agreement | Not applicable |
| Nomor Persetujuan Pelaksanaan Uji Klinik | Not applicable |
| Other Study ID Numbers | |
| Contact Person | Rima Haifa, S.Si, M. Farm-Klin |