The Skin Anti-Aging Effects of Vitamin K2 (MK-7): a Clinical Split-Face/Neck Trial

Nanjing Ascend Biotech Technology Co., Ltd.

Status: Completed

Conditions: Skin Aging of Face and Neck

Treatments: Other: Face-and-Neck Cream (with 0.05% Vitamin K2); Other: Placebo Face-and-Neck Cream

Study type: Interventional

Funder types: Industry

Identifiers

NCT07403942

2024-293-ZH-262

Details and patient eligibility

About

The goal of this clinical trial is to evaluate the efficacy of a facial and neck cream containing Vitamin K2 in improving skin hydration, elasticity, firmness, and reducing wrinkles in 36 female participants aged 35-60 years with concerns of facial dryness, dullness, laxity, and neck lines. The main questions it aims to answer are:

Does the test cream significantly improve skin hydration (Corneometer), reduce transepidermal water loss (Vapometer), and enhance skin elasticity and firmness (Cutometer) compared to a control cream?

Does the test cream significantly reduce wrinkle severity (assessed by Rz and Ra parameters via AEVA-HE rapid optical imaging) in areas including the neck, cheeks, marionette lines, and crow's feet compared to a control cream?

Researchers will compare the test cream (applied to one randomized half-face and neck) to the control cream (applied to the contralateral half-face and neck) to see if the test cream demonstrates superior efficacy in improving the measured skin parameters.

Participants will:

Apply the test cream to one assigned side of the face and neck, and the control cream to the other side, twice daily for 8 weeks.

Attend evaluation visits at baseline, 2, 4, and 8 weeks for instrumental measurements (skin hydration, TEWL, elasticity, rapid optical imaging, facial imaging) and to complete subjective questionnaires.

Enrollment: 36 patients

Sex: Female

Ages: 35 to 60 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Is a Chinese female aged between 35 and 60 years (inclusive).
• Presents with facial skin concerns including dryness, dullness, and laxity.
• Has crow's feet (outer canthus wrinkles) with a visual assessment grade of 2 to 4 (on a 0-6 scale).
• Self-reports concerns about neck wrinkles.
• Is in good general health at the time of screening.
• Is willing and able to provide written informed consent.
• Is willing and able to comply with all study procedures and product usage requirements for the duration of the study.

Exclusion criteria

• Is planning pregnancy, is pregnant, lactating, or within 6 months postpartum.
• Has a history of severe systemic diseases, immunodeficiency, or autoimmune diseases.
• Has a history of allergic diseases or has experienced cosmetic allergies within the past 1-2 years.
• Has had dermatological diseases on the test areas (face and neck) or is undergoing related medical treatment within the past 3 months.
• Has an active cold, influenza, or other acute illness at the study start that may affect participation.
• Is currently participating, or has participated within the past month, in another clinical study involving the test areas.
• Is deemed unsuitable for participation by a dermatologist's assessment.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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36 participants in 2 patient groups, including a placebo group

Placebo Face-and-Neck Cream

Placebo Comparator group

Description:

Participants apply the Placebo Face-and-Neck Cream (base formulation without Vitamin K2) to the contralateral half of the face and neck. Used twice daily (morning and evening) for 8 weeks.

Treatment:

Other: Placebo Face-and-Neck Cream

Face-and-Neck Cream

Active Comparator group

Description:

Participants apply the Face-and-Neck Cream (containing 0.05% Vitamin K2) to one randomly assigned half of the face and neck. Used twice daily (morning and evening) for 8 weeks.

Treatment:

Other: Face-and-Neck Cream (with 0.05% Vitamin K2)