Status:
NOT_YET_RECRUITING
The Relationship Between Microbioma Balance and Acne Vulgaris as a New Acne Treatment
Lead Sponsor:
Universitas Padjadjaran
Collaborating Sponsors:
PT. Prodia Stem Cell Indonesia
B-Crobes Laboratory (M) Sdn Bhd
Conditions:
Acne Vulgaris
Eligibility:
All Genders
13-45 years
Phase:
PHASE2
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. Dysbio...
Detailed Description
Acne cases have a very high number of visits to doctors, around 87%, especially in teenagers, which has implications for the psychological impact where long treatment with repeated inflammation for qu...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2026
Estimated Enrollment :
64 Patients enrolled
Trial Details
Trial ID
NCT06925386
Start Date
May 1 2025
End Date
May 1 2026
Last Update
April 13 2025
Active Locations (1)
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1
Rumah Sakit Umum Daerah Bali Mandara
Denpasar, Bali, Indonesia, 80116