Lotion and Toner Bundle 4-Week Lifting Efficacy Study

NCT ID: NCT07127653

Last Updated: 2025-08-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 132 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-01-23
• Study Completion Date: 2025-03-31

Brief Summary

This is a single-center, parallel-arm, 4-week interventional study designed to evaluate the lifting and firming efficacy of two facial care regimens in middle-aged Chinese women. Participants were randomly assigned to use either a retinol-based day cream or a lotion-and-toner bundle. The study included dermatologist assessment, standardized facial photography, and self-assessment questionnaires. A total of 132 healthy women aged 45-55 with facial skin sagging were enrolled. The primary objective was to compare improvement in lifting grades after 4 weeks of product use. The trial was conducted at China-Norm Quality Technical Service Co., Ltd., in Shanghai, China.

Detailed Description

This 4-week study evaluated the efficacy of two skincare regimens on facial lifting and firmness in middle-aged Chinese women. Participants were randomly assigned to one of two arms: (1) retinol-based day cream or (2) a bundle of toner and lotion. The study included a 3-week wash-out period, followed by a 4-week treatment phase with full-face application. Assessments were conducted at T0 (baseline), Timm (immediate post-use), and T4w (end of 4-week use), using dermatologist grading (0-9 scale), DEEP imaging system, and self-reported questionnaires. Participants were required to avoid other skincare products during the study. A total of 132 subjects were enrolled; at least 80 completed clinical evaluation. The primary outcome was improvement in lifting grade from T0 to T4w; secondary outcomes included imaging analysis and subjective satisfaction. The study followed GCP principles and received ethical approval from the Ethics Committee at China-Norm. No serious adverse events were reported.

Conditions

Lifting Efficacy; Facial Aging

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Retinol Day Cream Group

Participants in this arm applied a retinol-based anti-wrinkle day cream to the full face for 4 weeks following a 3-week washout period. Assessments were conducted at baseline (T0), immediate post-use (Timm), and after 4 weeks of use (T4w). Evaluations included dermatologist lifting grade, DEEP imaging, and self-assessment questionnaire.

Group Type: EXPERIMENTAL

Lotion and Toner Bundle

Intervention Type: OTHER

A skincare regimen including a dermalift toner and a milky lotion. Applied twice daily (morning and evening) to the full face for 4 weeks.

Lotion and Toner Group

Participants in this arm applied a lotion and toner bundle to the full face for 4 weeks following a 3-week washout period. Assessments were conducted at baseline (T0), immediate post-use (Timm), and after 4 weeks of use (T4w). Evaluations included dermatologist lifting grade, DEEP imaging, and self-assessment questionnaire.

Group Type: EXPERIMENTAL

Retinol-Based Day Cream

Intervention Type: OTHER

A commercially available day cream containing retinol and moisturizing ingredients. Applied twice daily (morning and evening) to the full face for 4 weeks.

Interventions

Retinol-Based Day Cream

A commercially available day cream containing retinol and moisturizing ingredients. Applied twice daily (morning and evening) to the full face for 4 weeks.

Intervention Type: OTHER

Lotion and Toner Bundle

A skincare regimen including a dermalift toner and a milky lotion. Applied twice daily (morning and evening) to the full face for 4 weeks.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 1. Chinese female with 45-55 years old. 2. All skin types (dry, normal, oily or mixed). 3. Regular users for toner, lotion and cream. 4. Self-claim with lack of firmness and has sagging concern. 5. Presenting with corresponding severity for the attribute evaluated by Dermatologist included:

• Lifting (global face): 3≤grade≤6 (0-9 scale) 6. The BMI range should ≤24.9, and the BMI (BMI =Weight (kg)/ Height²(m²)) should remain stable within the range throughout the entire testing period. 7. Did not participate any clinical test or cosmetic product test on skin within 3 months.

8. Did not participate any chemical procedures for previous 6 months and during the whole study.

9. No disagreement of dermatologist because of other reasons that exclude the participation of the subject.

10. In general, good health at the time of the study. 11. Willing and able to participate as evidenced by signing of informed consent & photo release form.

12. Must be willing to comply with all study protocol requirements (pay attention: only use the skin care products provided during the study, not take topical or oral treatment like retinol, hormone, antioxidant health-care products which may affect the test product).

Exclusion Criteria

• 1. Pregnant or breast-feeding woman or woman planning pregnancy during the study.

2. Subject deprived of rights by a court or administrative order. 3. Major subject to a guardianship order. 4. Subject residing in a health or social care establishment. 5. Patient in an emergency setting. 6. Subject with a skin disease in the test areas as well as skin allergy (particularly e.g., acne, rosacea, eczema). 7. Subject presenting a stable or progressive serious disease (per investigator's assessment).

8. Immuno-compromised subject. 9. Subject with history of allergy to cosmetic or personal care products or ingredients.

10. Subject presenting excessive exposure to sunlight or UV radiation (investigator's assessment).

11. Subject with history of sunlight sensitivity or allergies. 12. Subjects regularly practicing aquatic or nautical sports. 13. Subjects regularly attending a sauna. 14. Subject with physical highly sensitive constitution. 15. Subject with cardiovascular or circulatory history. 16. Subject with a history of skin cancer or malignant melanoma. 17. Intake of antihistamines, antibiotics, corticosteroids, non-steroidal anti-inflammatories or immune suppressants in the last 6 months before study

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

ChinaNorm

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Shanghai China-norm Quality Technical Service Co., Ltd., Shanghai, Shanghai 200072

Shanghai, , China

Countries

China

Other Identifiers

C25005018

Identifier Type: -

Identifier Source: org_study_id