Evaluation
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Safety Test

Evaluation

  • Human skin primary
    Irritation Test

  • 시험 내용
    • Visual assessment
    • Skin wrinkles parameters analysi
    • Subjective evaluation
    • Safety assessment
  • 피험자 수

    ≥ 30

  • 시험 기간

    1 weeks

  • Human skin repeat
    insult patch Test

  • 시험 내용
    • Shelanski & Shelanski Method
    • To evaluate the sensitizing potential
    • Induction period (3 weeks): 24hrs occlusion patch every other day
    • Resting period (2 weeks): no treat
    • Challenge period: 48 hrs occlusion patch and clinical examination at 30 minutes, D1, D2 and D3 after removal
  • 피험자 수

    ≥ 50

  • 시험 기간

    6 weeks

  • Human skin sting
    potential Test

  • 시험 내용
    • To determine the skin stinging potential
    • Stingers are selected using 5% lactic acid
    • Stinging potential is assessed according to the intensity
    • of the sensations (tightness, burning, itching and stinging)
  • 피험자 수

    ≥ 10

  • 시험 기간

    2 weeks

  • Human skin photo
    toxicity Test

  • 시험 내용
    • To evaluate the photo-irritating potential
    • Determination of MED using Solar simulator light
    • The UV-A is irradiated on test site after patch removal
    • Clinical examination at 30 minutes, D1, D2 and D3 after removal
  • 피험자 수

    ≥ 20

  • 시험 기간

    1 weeks

  • Human skin cumulative
    Irritation Test

  • 시험 내용
    • To evaluate the local tolerance after 9 epicutaneous repeated appli cations by every other day for 3 weeks Evaluation at every removal time
  • 피험자 수

    ≥ 30

  • 시험 기간

    3 weeks

  • Human eye rim
    usage Test

  • 시험 내용
    • In-use test by eye rim applications for 4 weeks  Evaluating the objective and the subjective irritation every week (or every day)
  • 피험자 수

    ≥ 25

  • 시험 기간

    4 weeks

  • Human eye
    tolerance Test

  • 시험 내용
    • To evaluate the physical and subjective (stinging) eye irritation pot entail
    • Evaluation via kinetics and maximized frontal application (wash off type)
    • Evaluation of subjective signs, physical clinical evaluation and Examination by instillation of fluorecin and lissamine green using a slit lamp
  • 피험자 수

    ≥ 35

  • 시험 기간

    1 Weeks

  • Human skin adverse
    reaction Test

  • 시험 내용
    • To determine the skin adverse reaction
    • Self assessment (examination of tolerance)
    • Clinical assessment (physical symptoms)
  • 피험자 수

    ≥ 30

  • 시험 기간

    3 Days

  • Human skin usage Test

  • 시험 내용
    • In-use test by repeated cutaneous applications for 4 weeks Evaluating the objective and the subjective irritation every week (or every day)
  • 피험자 수

    ≥ 25

  • 시험 기간

    4 Weeks

  • Human skin photo
    sensitization Test

  • 시험 내용
    • To evaluate the photo-sensitization potential
    • Induction period (3 weeks): 24hrs occlusion patch every other day and the UVA be irradiated on test site after patch removal
    • During 2 weeks resting period, no treat
    • Challenge period: 48 hrs occlusion patch and the UVA is irradiate d test site after patch removal. clinical examination at 30
  • 피험자 수

    ≥ 30

  • 시험 기간

    6 Weeks

  • Human skin antimicrobial
    effect Test

  • 시험 내용
    • To evaluate the antimicrobial effect
    • Escherichia coli
    • Staphylococcus aureus
    • Total microbial count
  • 피험자 수

    ≥ 15

  • 시험 기간

    2 weeks

  • Human Skin
    Sensitivity Test

  • 시험 내용
    • Sensory irritation evaluation
    • CPT Value
    • Hydration measurement
    • Subjective evaluation
  • 피험자 수

    ≥ 20

  • 시험 기간

    4 weeks