Acne Vulgaris
Conditions
Interventions
Yang03 Group:Taking Yang03 probiotic
Yang02 Group:Taking Yang02 probiotic
Yang 02+Yang 03 Group:Taking Yang 02+Yang 03 probiotic
The Placebo Group:Taking Placebo
Sponsors
Dematology Hospital of Southern Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 40 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18-40 years (inclusive), regardless of gender; 2. Investigator’s Global Assessment (IGA) score of 3 or 4 (i.e., moderate or severe); 3. Facial lesion counts must meet the following criteria: 30–75 inflammatory lesions, 30–100 non-inflammatory lesions, and no more than 2 nodules in total; 4.Women of childbearing potential must be willing to use effective contraception from the time of signing the informed consent form until 3 months after the last dose of the trial drug; 5.Subjects must accept the possibility that their AV condition may not improve or could even worsen during the study; 6.Subjects must be willing and able to comply with the study requirements, understand and adhere to the protocol, follow restrictions and relevant instructions, use the trial product as directed, and attend scheduled follow-up visits.
Exclusion criteria
Exclusion criteria: 1. Known allergy to the investigational product or any of its excipients; 2.Presence of severe cystic acne at screening; 3.Secondary acne (e.g., occupational acne such as chloracne, or steroid-induced acne); 4.Concurrent facial skin conditions that may interfere with acne evaluation or require concomitant treatment, such as solar dermatitis, psoriasis, seborrheic dermatitis, rosacea, folliculitis, or eczema; 5.Dense facial hair that, in the investigator’s opinion, may hinder accurate assessment of acne severity or lesion count; 6. History or current diagnosis of inflammatory bowel disease (e.g., ulcerative colitis, Crohn’s disease, pseudomembranous colitis, chronic diarrhea, antibiotic-associated colitis, or bloody diarrhea); 7.Previous diagnosis of polycystic ovary syndrome (PCOS); 8.History of palmar-plantar erythrodysesthesia syndrome; 9.History of dry skin due to conditions such as ichthyosis or atopic dermatitis; 10.Previous treatment for hair loss or family history of hair loss; 11.Severe dry eye syndrome or other significant ocular disease deemed ineligible for the study; or unwillingness to avoid wearing contact lenses from baseline until the last dose; 12.History of any severe systemic disease or major surgery affecting the digestive, circulatory, nervous, hematological, immunological, or psychiatric systems; 13.Use of functional skincare products for acne within 2 weeks prior to treatment initiation (e.g., Yuze Acne-Care Soothing Spray, Zilaixi Aloe Anti-Acne Repair Gel, HFP Acne Removal & Brightening Kit or HFP Home Facial Oligopeptide Serum, Manting Acne-Control Cleansing Cream, Lao Shen Yi Acne Essence, Zhi Xuantang Herbal Acne Repair, La Roche-Posay Effaclar Duo); 14.Recent use of topical anti-acne treatments: (i) Within 2 weeks prior to treatment: benzoyl peroxide, antibiotics (e.g., erythromycin, lincomycin, clindamycin), azelaic acid, sulfonamides, corticosteroids, or salicylic acid; (ii) Within 4 weeks prior to treatment: retinoids (including tazarotene, adapalene, tretinoin); (iii) Within 4 weeks prior to treatment: light-based or laser therapy, dermabrasion, or chemical peels; 15.Recent use of systemic anti-acne therapies: (i) Systemic corticosteroid therapy (including intramuscular injection) within 4 weeks prior to treatment (stable use of nasal/inhaled or ocular corticosteroids is permitted if dose and frequency unchanged for =4 weeks); (ii) Antibiotic use (doxycycline, minocycline, erythromycin, roxithromycin, azithromycin) within 4 weeks prior to treatment (except for courses <=5 days) or within 1 week prior to treatment; (iii) Spironolactone use within 8 weeks prior to treatment (except for courses <=5 days) or within 1 week prior to treatment; (iv) Use of systemic retinoids within 6 months prior to treatment; 16.Use of traditional Chinese medicine known to affect acne within 4 weeks prior to treatment; 17.Participation in any clinical trial or use of any investigational drug with a mechanism related to this trial within 3 months prior to treatment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage change in total lesion count; | — |
Secondary
| Measure | Time frame |
|---|---|
| Taxonomic composition and relative abundance of the gut microbiota;Percentage change in non-inflammatory lesion count from baseline;Absolute change in total lesion count from baseline;Percentage change in inflammatory lesion count from baseline;Percentage of IGA treatment success;Sebum secretion level of the subjects;Adverse events;Absolute change in inflammatory lesion count from baseline; | — |
Countries
China
Contacts
Public ContactBin Yang
Dematology Hospital of Southern Medical University
Outcome results
None listed