male or female patients aged 18-45 years with moderate to severe acne vulgaris monopolar radiofrequency, acne vulgaris, acne scar, sebaceous gland, sebum excretion
Conditions
Interventions
Treatment with non-ablative monopolar radiofrequency (Oligio) using a tip size of 4.0 cm2 in single pulse mode on both cheeks, with 50% overlap per shot. Each side will receive 150-200 shots at energy
Experimental Procedure/Surgery
non-ablative monopolar radiofrequency
Sponsors
Wontech Asia Co., Ltd.
Eligibility
Sex/Gender
All
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: 1. male or female, aged 18-45 years, diagnosed with moderate to severe acne vulgaris 2. There are inflamed acne on both cheeks. 3. Consent to participate in the program voluntarily and provide written evidence in the informed consent form. 4. ability to follow research protocols
Exclusion criteria
Exclusion criteria: 1. Volunteers who have taken systemic treatments for acne (such as antibiotics, anti-androgens like spironolactone, oral contraceptive pills (OCPs)) within the 4 weeks prior to participating in the study. 2. Volunteers who have taken isotretinoin within the 6 months before participating in the research study. 3. Volunteers who have used or received hormonal contraception, including oral contraceptive pills, injections, implants, or IUDs, or who are taking hormone therapy for other indications. 4. Volunteers who have received laser treatment (either ablative or non-ablative lasers) on the face within 4 weeks before participating in the research study. 5. Volunteers who have taken oral corticosteroids within the 8 weeks before joining the study, or who have applied corticosteroid creams or ointments on the area to be tested within the last 2 weeks. 6. Female participants who are planning to become pregnant, are pregnant, or are breastfeeding. 7. Participants with a history of allergic reactions to any ingredients in the products being tested. 8. Participants with underlying medical conditions that affect the severity of acne, such as Polycystic Ovarian Syndrome (PCOS). 9. Participants with a history of herpes simplex infection (cold sores) or active dermatitis within the last 3 months, or a history of skin cancer. 10. Participants with a history or detection of rashes or other skin diseases on the face that may interfere with accurate assessment of acne and acne scars, such as seborrheic dermatitis, rosacea, etc.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Efficacy of non-ablative monopolar radiofrequency in reducing the number of inflammatory acne baseline, 1 month, 2months, 3 months, 6 months The outcome was based on the inflammatory acne lesion count on both cheeks. | — |
Secondary
| Measure | Time frame |
|---|---|
| Efficacy of non-ablative monopolar radiofrequency in reducing the number of non inflammatory acne baseline, 1 month, 2 month, 3 month, 6 month The outcome was based on the non inflammatory acne lesion count on both cheeks,Efficacy of non-ablative monopolar radiofrequency in reducing the severity of acne baseline, 1 month, 2 month, 3 month, 6 month The outcome was based on the investigator global evaluation acne (IGEA) scale.,Efficacy of non-ablative monopolar radiofrequency in reducing the severity of atrophic acne scar baseline, 1 month, 2 month, 3 month, 6 month Qualitative Global Scarring Grading System (GSGS) on both cheek,Impact of non-ablative monopolar radiofrequency on sebum level of skin surface baseline, 1 month, 2 month, 3 month, 6 month sebumeter,Impact of non-ablative monopolar radiofrequency on pore size and porphyrin level of skin surface baseline, 1 month, 2 month, 3 month, 6 month Visia ,Canfield scientific USA,Efficacy of non-ablative monopolar radiofrequency on skin laxity baseline, 6 month The outcome was based on the Alexides-Armenaka skin laxity grading scale.,The safety of using non-ablative monopolar radiofrequency for acne treatment, focusing on pain. baseline, 1 month, 2 month Verbal Analogue Scale (VAS) for pain scores,Side effects of using non-ablative monopolar radiofrequency for acne treatment (immediate and delayed) baseline, 1 month, 2 month, 3 month, 6 month Yes/No question,Patient satisfaction 6 month satisfaction score (0-10),Patient satisfaction 1 month, 2 month, 3 month, 6 month Global Aesthetic Improvement Scale (5-point SGAIS) | — |
Countries
Thailand
Contacts
Public ContactNatcha Chottawornsak
Faculty of Medicine, Chulalongkorn university
Outcome results
None listed