None listed
Conditions
Interventions
Medical Device : All participants will be randomly assigned to apply the investigational device (magnesium microneedle patch) to one side of the face (left or right), and the control device (a standar
Sponsors
LABnPEOPLE Co., Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) Healthy male or female subjects aged 9 years or older at the time of signing the consent. (2) Subjects with no significant difference in the number of acne lesions between the left and right sides of the face, as determined by the investigator. (3) Subjects with an Investigator’s Global Assessment (IGA) score of 2 (mild) or 3 (moderate) on the entire face, as assessed by the investigator. (4) Subjects with at least two inflammatory acne lesions (papules or pustules) on each side of the face (left and right). (5) Subjects who agree to discontinue all dermatologic treatments or procedures for acne during the whole investigation period (Visit 1 ~ Visit 3). (6) Subjects who agree not to change their usual facial cleanser during the study period. (7) Subjects who agree to use only the moisturizer provided by the investigator during the study period. (8) Subjects who voluntarily sign the informed consent form after receiving a full explanation of the clinical trial.
Exclusion criteria
Exclusion criteria: (1) Subjects with any of the following medical histories confirmed or suspected at screening: a. Skin abnormalities or inflammatory skin disorders other than acne b. Hypersensitivity or allergic reactions to any components of the investigational device (2) Subjects who have used or plan to use the following medications or treatments on the facial area at the time of screening: a. Topical acne treatments (e.g., retinoids, antibiotics, benzoyl peroxide) within 4 weeks prior to screening b. Acne treatments that may affect efficacy evaluation (e.g., oral retinoids, chemical peeling, skin scaling, etc.) within 24 weeks prior to screening (3) Subjects who have used functional cosmetics for acne within 2 weeks prior to screening (4) Women who are pregnant, breastfeeding, or planning to become pregnant during the study period (5) Subjects who have taken oral contraceptives within 3 months prior to screening (6) Subjects who participated in another clinical trial and received an investigational product (IP) or investigational device (ID) within 4 weeks prior to screening (7) Any subjects considered by the investigator to be unsuitable for participation in the clinical trial for any reason
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Michaelson’s Acne Severity Index (ASI) | — |
Secondary
| Measure | Time frame |
|---|---|
| Satisfaction rate | — |
Countries
Korea, Republic of
Contacts
Public ContactJunesoo Jeon
Samsung Medical Center
Outcome results
None listed