NCT07127653

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
132

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 23, 2025

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 16, 2025

Completed
15 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2025

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

August 1, 2025

Completed
16 days until next milestone

First Posted

Study publicly available on registry

August 17, 2025

Completed
Last Updated

August 17, 2025

Status Verified

August 1, 2025

Enrollment Period

2 months

First QC Date

August 1, 2025

Last Update Submit

August 14, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Clinical Assessment by Dermatologist

    Lifting grade (0-9 scale) will be evaluated by dermatologist at T-3w, T0 (baseline), Timm and T4w.Six areas will be evaluated separately: eyebrow, upper eyelid, nasolabial zone, apple cheek, corner of mouth and jaw.

    Baseline and Week 4

Secondary Outcomes (2)

  • Change in Facial Wrinkle Depth Measured by Standardized Digital Photography and Image Analysis Software

    Baseline and Week 4

  • Questionnaire

    Baseline and Week 4

Study Arms (2)

Retinol Day Cream Group

EXPERIMENTAL

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.

Other: Lotion and Toner Bundle

Lotion and Toner Group

EXPERIMENTAL

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.

Other: Retinol-Based Day Cream

Interventions

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

Lotion and Toner Group

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

Retinol Day Cream Group

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • \. 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.
  • \. Did not participate any chemical procedures for previous 6 months and during the whole study.
  • \. No disagreement of dermatologist because of other reasons that exclude the participation of the subject.
  • \. 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.
  • \. 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).

You may not qualify if:

  • \. Pregnant or breast-feeding woman or woman planning pregnancy during the study.
  • \. 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).
  • \. Immuno-compromised subject. 9. Subject with history of allergy to cosmetic or personal care products or ingredients.
  • \. Subject presenting excessive exposure to sunlight or UV radiation (investigator's assessment).
  • \. 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Shanghai, China

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 1, 2025

First Posted

August 17, 2025

Study Start

January 23, 2025

Primary Completion

March 16, 2025

Study Completion

March 31, 2025

Last Updated

August 17, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

Locations