Cream Short-term Efficacy Clinical Study

NCT ID: NCT07067086

Last Updated: 2025-07-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 42 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-12-11
• Study Completion Date: 2024-12-16

Brief Summary

This study aimed to evaluate the short-term efficacy of a facial cream (Formula# 899675 44A) on improving various skin quality and wrinkle parameters after a single application. A total of 44 healthy Chinese women aged 20 to 50 years, with all skin types including 50% sensitive skin, were enrolled. Participants applied the cream once to the full face and neck under supervision, and outcomes were assessed at baseline (T0), 10 hours (T10h), and 24 hours (T24h) post-application. Clinical evaluations and photo-based imaging were used to assess skin plumpness, smoothness, radiance, and multiple types of wrinkles. At the end of the study, 42 participants completed the protocol.

Conditions

Facial Wrinkles and Rhytides Reduction

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Test Cream Single Application Group

Participants applied the test cream (Formula# 899675 44A, 30 mL) once to the full face and neck under staff supervision. Application was followed by massaging designated wrinkle-prone areas including the forehead, crow's feet, underneath eyes, nasolabial folds, and neck folds. Clinical assessments and imaging analysis were performed at T0, T10h, and T24h post-application.

Group Type: EXPERIMENTAL

Test Cream

Intervention Type: OTHER

A facial cream (Formula# 899675 44A, 30 mL) was applied once by participants under supervision. 1g of cream was spread over the entire face and neck, followed by targeted massage on wrinkle-prone areas including forehead, crow's feet, underneath eyes, nasolabial folds, and neck folds. Clinical and photo-based evaluations were conducted at baseline (T0), 10 hours (T10h), and 24 hours (T24h) after application.

Interventions

Test Cream

A facial cream (Formula# 899675 44A, 30 mL) was applied once by participants under supervision. 1g of cream was spread over the entire face and neck, followed by targeted massage on wrinkle-prone areas including forehead, crow's feet, underneath eyes, nasolabial folds, and neck folds. Clinical and photo-based evaluations were conducted at baseline (T0), 10 hours (T10h), and 24 hours (T24h) after application.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 1.Chinese female with 20-50 years old (Must have 20-30 years old). 2.In general, good health at the time of the study. 3.All skin types, with 50% sensitive skin. 4.Regular users for cleanser, anti-aging cream and sunscreen product. 5.Self-declare with plumpness, smoothness and wrinkles problems. 6.Clinical grading by dermatologist in terms of: Underneath eye wrinkles: 2≤grade≤4; Forehead wrinkles: 1 <grade≤ 4; Crow's feet wrinkles: grade > 1; Skin smoothness: 3≤ grade≤ 6 (0-9 scale); Skin plumpness: 3≤ grade≤ 6 (0-9 scale); 7.Did not participate any clinical test or cosmetic product test on skin within 3 months.

8.Did not participate any chemical/beauty procedures for previous 6 months. 9.No disagreement of dermatologist because of other reasons that exclude the participation of the subject.

10.Were willing and able to participate as evidenced by signing of informed consent and photo release form.

11.Must be willing to comply with all study protocol requirements.

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: FEMALE
• 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

C24005077

Identifier Type: -

Identifier Source: org_study_id