None listed
Conditions
Interventions
Medical Device : This clinical trial aims to evaluate the clinical efficacy and safety of a high-intensity ultrasound therapy device (model name: CELLEON) in improving inflammatory acne in patients wi
Sponsors
Dankook Univeristy Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1 .Male and female participants aged 15 years or older and under 40 years. 2. Individuals who voluntarily decide to participate in this clinical trial and provide written informed consent. 3. For participants under the age of 19, written consent must also be obtained from a legal guardian. 4. Individuals with mild to moderate inflammatory acne presenting with at least 10 inflammatory lesions (papules and pustules) smaller than 1 cm in diameter on the facial area (cheeks around the zygomatic bone, forehead, and chin area below the lips). 5. Healthy individuals with no diseases other than acne. ? This clinical trial is intended to evaluate the efficacy of a medical device for inflammatory acne. To minimize systemic effects, only healthy subjects without other diseases are eligible. Concomitant use of other medications is not permitted. 6. For female participants, those who agree to use contraception during the study period and have no plans to become pregnant.
Exclusion criteria
Exclusion criteria: 1. Patients with dermatological conditions requiring treatment other than acne. 2. Patients who have used acne treatment medications (e.g., benzoyl peroxide, topical antibiotics, retinoids, azelaic acid, corticosteroids, systemic antibiotics, etc.) within 3 months prior to study participation. - Patients are excluded even if the medication was prescribed for reasons other than acne treatment. 3. Patients who have used medications known to cause pustular eruptions (e.g., acneiform eruptions, acute generalized exanthematous pustulosis) within 3 months prior to study participation, including: - Beta-lactam antibiotics - Macrolide antibiotics - Calcium channel blockers (antihypertensive agents) - Acneiform eruptions should be differentiated from other pustular dermatoses such as pustular psoriasis, subcorneal pustular dermatosis, impetigo herpetiformis, acute generalized exanthematous pustulosis, erythema multiforme, and Sweet's syndrome. - Typically, pustules the size of pinheads appear on erythematous skin throughout the body, accompanied by symptoms such as fever, headache, myalgia, and sore throat. The rash often appears within 24 hours after drug administration and may be accompanied by leukocytosis. 4. Individuals who plan to use functional cosmetics, exfoliants, skincare products, or soaps aimed at controlling sebum or alleviating acne during the study period. 5. Individuals who have received facial treatments such as botulinum toxin (Botox), fillers, laser therapy, radiofrequency therapy, or chemical peels within 6 months prior to the date of informed consent. 6. Individuals with moderate to severe facial erythema due to conditions such as rosacea, allergies, or eczema, or those with scarring, hypertrophic scars, or a tendency for keloid formation. 7. Individuals who have participated in other clinical trials within 3 months prior to the date of informed consent. 8. Pregnant or breastfeeding women, or women planning to become pregnant. 9. Illiterate individuals or foreigners who are unable to understand the clinical trial explanation document.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes in the number of papules and pustules, based on expert visual assessment between groups, 4 weeks after baseline | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in the number of papules and pustules from baseline to Week 2, based on expert visual assessment between groups;Change rate in skin sebum content between groups at Weeks 2 and 4 compared to baseline, as measured using a Sebumete;Change rate in pores between groups at Weeks 2 and 4 compared to baseline;Change rate in acne severity classification (GAGS, Global Acne Grading System) between groups at Weeks 2 and 4 compared to baseline;Change rate in satisfaction with acne-prone skin compatibility between groups at Weeks 2 and 4 compared to baseline | — |
Countries
Korea, Republic of
Contacts
Public ContactPark Byung Cheol
Dankook Univeristy Hospital
Outcome results
None listed