MedPath

Anti-Redness Clinical Study

Not Applicable
Completed
Conditions
Redness
Registration Number
NCT07200492
Lead Sponsor
ChinaNorm
Brief Summary

This clinical study is a single-center, randomized, split-face, on-site controlled trial conducted at Shanghai China-Norm Quality Technical Service Co., Ltd. The primary objective is to evaluate the efficacy of Eucerin Ultrasensitive Repair Intensive Source Serum in providing instant and long-lasting (24-hour) soothing and repairing effects under induced redness conditions. The design involves recruiting 30 healthy Chinese female subjects aged 18-60 years, who meet stringent inclusion/exclusion criteria, including absence of skin conditions and no recent participation in similar studies. Redness is induced using 50% Glycolic Acid on the entire face and tape stripping on both forearms.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
Female
Target Recruitment
32
Inclusion Criteria
  1. Chinese female whose age range from 18 to 60 years old;
  2. Be in general good health and good mental state;
  3. Have no any broken,scars,birthmarks and other imperfections on the test area;
  4. Redness/erythema≥grade 2 after modelling inducing and the score of redness must be increased after inducing;
  5. Not currently be participating in any other study involving the test area(Face and Forearm);
  6. Not have participated in any other study involving the test area in the past one month;
  7. Be willing to read,understand and able to sign the Informed Consent Form and Photo Release From;
  8. Be willing to comply with all study protocol requirements.
Exclusion Criteria
  1. Intending to get pregnant, be pregnant, be lactating, be within 6 months of delivery or be unwilling to take necessary precautions to avoid a pregnancy;
  2. Having used antihistamine drugs in the past 1 week or immunosuppressants in the past 1 month;
  3. Taken anti-allergic drug/injections in the past 1 month;
  4. Presently have allergies, allergic dermatitis or skin disease;
  5. Have sensitivity or even allergy to topical products, ingredients or fragranced products;
  6. Have history of allergies;
  7. Have history of suffering from skin diseases (such as psoriasis, eczema, skin cancer, etc.);
  8. Have used any anti-inflammatory treatment on the test area within 2 months prior to this study starting date;
  9. Has a chronic medical condition that may interfere with testing (e.g., asthma, insulin-dependent diabetes, lupus, rheumatoid arthritis or other immune/auto-immune diseases);
  10. Have used any scrubs or peeling product (regardless of method) or self-tanning products or oil control products in the past 3 days;
  11. Have received cosmetic medical procedures on the face (such as injectable anti-wrinkle products, cosmetic surgery, tattoo removal, home light facial procedures or home use medical devices, etc.) in the past 1 month;
  12. Have excessive sun exposure or ultraviolet light exposure in the past 1 month;
  13. Have applied ortho-hydroxybenzoic acid, hydroquinone in the past 3 months; or used prescriptions (such as antibiotic, retinoids, alpha hydroxyl acid and steroid), oral contraceptives;
  14. Avoid providing emergency contact;
  15. Subjects that are not compliant with the selection criteria or not proper for participation as determined by Principal Investigator;
  16. An employee of the cosmetic companies or Shanghai China-Norm Quality technical service Co., Ltd.

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Primary Outcome Measures
NameTimeMethod
Skin Erythema Index via Mexameter® MX 18From Baseline to 24-hour after product repeat application
Colorimetry (avalue) via Chromameter CM26dG *from Baseline to 24-hour after product repeat application
Skin Scaliness (Desquamation) via Squamescan® 850Afrom Baseline to 24-hour after product repeat application
Forearm Skin Redness (avalue) via Cross-Polarized Light Imaging *From Baseline to 24-hour after product repeat application

The a\*value is a parameter in the CIELAB color space (also known as Lab) that quantifies a color's position along the red-green axis .

Facial Skin Redness and Colorimetry (a* value) via VISIA-CRP Imagingfrom Baseline to 24-hour after product repeat application
Skin Surface Evenness (SEsc) via UV Video Capture and SELS Analysisfrom Baseline to 24-hour after product repeat application
Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

Shanghai China-norm Quality Technical Service Co., Ltd.

🇨🇳

Shanghai, Shanghai Municipality, China

Shanghai China-norm Quality Technical Service Co., Ltd.
🇨🇳Shanghai, Shanghai Municipality, China

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