Acne
Conditions
Interventions
Phototherapy group:Red Light Therapy
Medicated Mask Group:Chinese herbal mask
Combination Therapy Group:Chinese herbal medicine mask and red light therapy
Sponsors
Shenshan Medical Center, Memorial Hospital of Sun Yat-sen University
Eligibility
Sex/Gender
All
Age
18 Years to 50 Years
Inclusion criteria
Inclusion criteria: 1: Age 18-50 years (including boundary values), no gender restrictions; 2: Patients clinically diagnosed with mild to moderate common acne (referencing the "Chinese Acne Treatment Guidelines" [1], revised edition 2019), classified as I-III grade according to the Pillsbury International Modified Grading Method [2], and with an Investigator Global Assessment (IGA) score of 2-3 points as assessed by the study physician; 3: Willing to use the test mask and undergo red light phototherapy during the trial period, and to avoid using any other medications or topical anti-infective drugs for the treatment of common acne during the treatment period; 4: No plans for pregnancy during the study period and for 3 months after the last treatment, with effective contraceptive measures in place; for women of childbearing age, the urine pregnancy test result within =7 days before the first administration of the trial drug must be negative; 5: Subjects who use cosmetics must have used the same brand/type for at least 14 days prior to participating in the study and must agree not to change the brand/type or frequency of use throughout the study period; 6: Agree to follow the trial treatment plan and visit schedule; 7: Agree to participate in the study and sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1: Known allergy to any components of traditional Chinese medicine mold casting, or patients with positive pre-sensitivity test behind the ear; 2: Known allergy to light; 3: Secondary acne patients, such as occupational acne and acne caused by corticosteroids; 4: Patients with concurrent other significant skin diseases that may affect efficacy evaluation or require concurrent treatment, such as solar dermatitis, psoriasis, seborrheic dermatitis, rosacea, folliculitis, eczema, and extremely severe acne; 5: Patients with a history of Crohn's disease or ulcerative colitis; 6: Patients with a history of severe clinical systemic diseases or surgery, such as cardiovascular, nervous, hematological, immune, or psychiatric diseases; 7: Abnormal vital signs (systolic blood pressure 150 mmHg, diastolic blood pressure 95 mmHg; heart rate 100 bpm); 8: Patients with clinically significant abnormal physical examination findings during screening, as judged by the investigator to affect the assessment of efficacy and safety of the subject, the trial results, or the subject's ability to safely participate throughout the study; 9: Known severe immunodeficiency, or long-term use of corticosteroids or immunosuppressants; 10: Pregnant women, breastfeeding women, or female subjects with positive urine pregnancy test during screening; 11: Subjects who consumed more than 14 units of alcohol per week in the 3 months prior to signing the informed consent (1 unit of alcohol = 360 mL beer or 45 mL alcohol with 40% alcohol content or 150 mL wine), or had a positive breathalyzer test for alcohol the day before dosing (breath alcohol content >0.0 mg/100 mL), or cannot abstain from alcohol during the trial (Phase I); or have a history of alcohol abuse (Phase II); 12: Subjects with a history of drug abuse in the past 5 years or drug use within 3 months prior to the trial, or positive urine drug abuse screening; 13: Subjects who used acne-functional skincare products targeting acne within 2 weeks prior to treatment (e.g., Yuzhi Clear Acne Soothing Spray, Zailaixi Aloe Vera Acne Repair Gel, HFP Acne Brightening Cleansing Set or HFP HomeFacial Oligopeptide Serum, Manting Clear Active Acne Control Cleanser, Lao Shen Yi Acne Essence, Zhi Xuantang Herbal Acne Repair, Laroche Posay/ La Roche-Posay Acne Water-Lotion Set, etc.); 14: Subjects who have used any of the following local anti-acne treatments prior to the start of the study (local anti-acne treatments, including but not limited to non-prescription acne cleansers or treatments): (1) Used within 2 weeks prior to treatment: benzoyl peroxide, antibiotics (e.g., erythromycin, lincomycin, clindamycin, etc.), nicotinamide, sulfonamide products, corticosteroids, and salicylic acid; (2) Used within 4 weeks prior to treatment: retinoids, including tazarotene, adapalene, and tretinoin; (3) Used within 8 weeks prior to treatment: phototherapy, dermabrasion, or chemical peels. 15: Subjects who have used any of the following systemic anti-acne treatments prior to the start of the study: (1) Used within 4 weeks prior to treatment: corticosteroid therapy (including intramuscular and intralesional injections). Stable use of intranasal or ocular corticosteroids (defined as unchanged dosage and frequency for at least 4 weeks prior to treatment); (2) Used within 4 weeks prior to treatment: antibiotics (e.g., doxycycline, minocycline, etc.) (except fo
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in inflammatory skin lesion count from baseline at week 5 of treatment.; | — |
Secondary
| Measure | Time frame |
|---|---|
| The treatment success rate at week 5 of treatment, based on the investigator's overall assessment (defined as a score of 0 or 1).;Change in non-inflammatory lesion count (nILC) compared to baseline after 5 weeks of treatment.;The change from baseline in Investigator's Global Assessment (IGA) at weeks 1, 3, and 5 of treatment.;Treatment success rate based on the Investigator's Global Assessment (IGA) at weeks 1, 3, and 5.;Counts of non-inflammatory lesions (nILC) and inflammatory lesions (ILC) at weeks 1, 3, and 5, and percentage change from baseline.; | — |
Countries
China
Contacts
Public ContactJing Zhou
Shenshan Medical Center, Memorial Hospital of Sun Yat-sen University
Outcome results
None listed