Skip to content

Efficacy and safety of Derma Shine Balance for Injection of Elravie Balance for Skin moisturizing

Efficacy and safety of Derma Shine Balance for Injection of Elravie Balance for Skin moisturizing; A 12week, Randomized, Double-blind, Parallel, Medical Device Clinical Trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CRIS
Registry ID
KCT0002402
Enrollment
60
Registered
2017-08-04
Start date
2016-06-08
Completion date
Unknown
Last updated
2019-03-11

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 : Elravie Balance, 2 ml apart every 2 weeks, Three times in four weeks, Inject after applying topical anesthetic agent. Normal saline, 2 ml apart every 2 weeks, Three times in four wee

Sponsors

Chung-Ang Univerisity Hospital
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: 1) 19~60 aged healthy females 2) Average score of less than 49 points for the determination of moisture retention on both cheeks. 3) Signed and informed consent; the purpose and the protocol of the study were explained to subjects

Exclusion criteria

Exclusion criteria: 1) Before screening, suffers from skin disease or medical treatment. 2) Hialluronsan,lidocain,amid type or Topical anesthetic with hypersensitive or allergic. 3) surgical procedure within 24 weeks. 4) A person receiving a feeler on her face within 6 months before clinical trial. 5) A person receiving a local graft on her face 6) A person who has a disease history before screening. (1) History or tendency of the keloid skin or hypertrophic scar (2) Connective tissue disorders (ex Scleroderma etc.) (3) Autoimmune disease (4) Clotting disorder (5) Injuries and scars on surgical sites that may affect the validity assessment (6) Inflammatory lesions or infections in surgical areas 7) Prohibited medication administered or required within 2 weeks of the clinical trial begins. 8) Anyone who receive another test medicine or plans to participate in other clinical trials Within 1 month of clinical trial start. 9) Using drugs that contain steroids on one's face or steroid drug taking a perpon. 10) Functional cosmetics for wrinkle improvement within 2 weeks of clinical trial start or those who use high moisturizing cosmetics. 11) People with mental illness such as schizophrenia, depression, drug addiction. 12) Those planning to become pregnant during pregnancy, during lactation, or within 3 months. 13) A smoker or a person less than one year after smoking cessation. 14) Those who think that the researcher is not suitable for this clinical trial.

Design outcomes

Primary

MeasureTime frame
Skin moisture

Secondary

MeasureTime frame
Skin moisture;Skin elasticity;Evaluation of the researcher's improvement;Assessment of Subject Satisfaction;Laboratory test ( Complete blood cell count/Blood chemistry test, urinalysis, blood coagulation test);Vital sign(pulse, blood pressure);Adverse event

Countries

Korea, Republic of

Contacts

Public ContactBeomjoon Kim

Chung-Ang Univerisity Hospital

Outcome results

None listed

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