Overview of Efficacy Study

Nanjing Medical University, Department  of Jiangsu Nanyida Toxicology Testing Center

Test Report /  Report number: 24NYQT-WT047-2b

Date of Issue: 04/07/2024

 

Introduction

The efficacy of a red light therapy device (CALYMA mask) was evaluated in a clinical trial conducted by Jiangsu Nanyida Toxicology Testing Center, Nanjing Medical University. The study involved 31 participants aged 22-50 years, who met inclusion criteria such as loose skin, fine lines, wrinkles, and pigmentation. The trial assessed improvements in skin parameters over 14 days of consistent use.

Methodology

  • Device Used: Red light therapy mask with multi-wavelength LEDs (Red 650nm, NIR 850nm, 1064nm, Yellow 590nm, Blue 460nm).
  • Frequency of Use: 10 minutes per mode, 6 sessions per week.
  • Test Environment: Controlled conditions (20-22°C, 40-60% humidity).
  • Assessment Tools:
    • Skin Wrinkle Scoring (Clinician-rated)
    • Melanin Index (MI): Measured pigmentation changes.
    • Skin Elasticity (R2): Elasticity below the cheekbone.
    • Skin Tightness (F4): Compactness below the cheekbone.

Key Results

  1. Wrinkle Reduction

    • Wrinkle scores improved by an average of 28.9% in 14 days.
    • Clinician ratings showed statistically significant improvement from D0 to D14 (P < 0.05).

  2. Skin Elasticity

    • Elasticity (R2 value) increased by 9.8% at D14, demonstrating firmer skin (P < 0.05).

  3. Skin Tone and Brightness

    • Melanin Index (MI) decreased by 11.2% at D14, indicating brighter and more even skin tone (P < 0.05).

  4. Skin Tightness

    • Compactness (F4 value) improved by 9.3%, reflecting enhanced skin firmness (P < 0.05).

  5. Acne Impact

    • Acne-related improvements were observed but not statistically significant in the small acne-subject subset.

Study Strengths

  • Comprehensive Testing: Skin parameters assessed with advanced instruments like VISIA imaging and elasticity testers.
  • Quick Results: Noticeable improvements in just 14 days of consistent use.
  • Safety: No adverse reactions were reported during the trial.

Conclusions

The study indicated that the CALYMA red light therapy mask showed measurable improvements in reducing wrinkles, enhancing skin elasticity, brightening the complexion, and promoting overall skin firmness. With these results, the device provides a non-invasive approach to addressing various skin concerns.

These findings align with CALYMA’s goal of delivering noticeable improvements within a short period.