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A multi-center, single-arm clinical study for the efficacy and safety of '10THERMA' on tissue coagulation and skin rejuvenation

A multi-center, single-arm clinical study for the efficacy and safety of '10THERMA' on tissue coagulation and skin rejuvenation

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CRIS
Registry ID
KCT0008709
Enrollment
31
Registered
2023-08-17
Start date
2023-08-01
Completion date
Unknown
Last updated
2023-08-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Medical Device : Pre-procedural procedure - Handpiece: Wipe thoroughly with rubbing alcohol (such as 70% isopropyl or ethanol swap) or a damp cloth. - Electrode: After removing the package, the handpi

Sponsors

Korean Society for Laser Medicine and Sugery
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) Adults between the ages of 30 and 70 2) Those who meet all of the following wrinkle scales - Those who want temporary improvement of both crow's feet and those who have a resting (expressionless) Crow's Feet Grading Scale of 1-2 points - Those who want temporary improvement of cheek wrinkle and have a cheek line grading scale of 1-2 points 3) Those who agree to stop all dermatological treatments or treatments, including wrinkle improvement of the facial area, during this clinical trial 4) Those who agree to take a picture of the facial area, including the eye area 5) Those who voluntarily decide to participate in this clinical trial and agree to the subject consent form in writing

Exclusion criteria

Exclusion criteria: 1) Those who have undergone cosmetic treatment such as laser, phototherapy, or surgery on the face within the last 6 months, or have undergone filler treatment using collagen, hyaluronic acid filler, or other materials 2) Those who have received radiotherapy in the facial area or have a history of chemotherapy and a history of malignant tumors 3) Those who have a history of infection, dermatitis, rash and heat-stimulated diseases such as herpes simplex and herpes zoster (including severe acne, fever or light, various allergies to beauty products, etc.), and those who have used steroid drugs 4) Those who have a history of keloid scarring, hypertrophic scarring, and abnormal wound healing 5) Those who have used whitening agents (Hydroquinone, Tranexamic acid, etc.), Isotretinoid (or Retinoid), light-sensitive drugs, and steroid drugs within the last 6 months 6) Women who are pregnant and breastfeeding (those who plan to become pregnant during the clinical trial or do not agree to appropriate contraceptive methods) 7) Other investigators judged to be inappropriate for this clinical trial

Design outcomes

Primary

MeasureTime frame
Comparing and evaluating the degree of improvement of cheek wrinkles using photographs of the subjects at week 4

Secondary

MeasureTime frame
Evaluation of the degree of improvement of cheek wrinkles at week 4 and 16 after application of medical devices, evaluation of the Global Aesthetic Improvement Scale by the investigator and subject, and evaluation of the degree of improvement of the wrinkle/texture index

Countries

Korea, Republic of

Contacts

Public ContactJiyoung Cho

Asan Medical Center

y0ncjy@naver.com+82-2-3010-3460

Outcome results

None listed

Source: CRIS (via WHO ICTRP) · Data processed: Feb 4, 2026