Efficacy of Four Topical Products to Improve Skin Longevity

NCT ID: NCT07118943

Last Updated: 2025-11-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 132 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-08-12
• Study Completion Date: 2025-10-09

Brief Summary

The objective of this study is to determine the efficacy of four topical products to improve facial skin longevity over an eight-week use period utilizing analysis of images and self-perception questionnaires.

Conditions

Aging; Wrinkle

Study Design

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

Study Groups

Face care product (eye cream)

The topical product (eye cream) containing Mitopure will be used for eight weeks.

Group Type: EXPERIMENTAL

Face care product

Intervention Type: OTHER

The topical product will be applied twice daily (morning and night).

Face care product (cream A)

The topical product (moisturizing formula A) containing Mitopure will be used for eight weeks.

Group Type: EXPERIMENTAL

Face care product

Intervention Type: OTHER

The topical product will be applied twice daily (morning and night).

Face care product (cream B)

The topical product (moisturizing formula B) containing Mitopure will be used for eight weeks.

Group Type: EXPERIMENTAL

Face care product

Intervention Type: OTHER

The topical product will be applied twice daily (morning and night).

Face care product (serum)

The topical product (serum) containing Mitopure will be used for eight weeks.

Group Type: EXPERIMENTAL

Face care product

Intervention Type: OTHER

The topical product will be applied twice daily (morning and night).

Interventions

Face care product

The topical product will be applied twice daily (morning and night).

Intervention Type: OTHER

Face care product

The topical product will be applied twice daily (morning and night).

Intervention Type: OTHER

Face care product

The topical product will be applied twice daily (morning and night).

Intervention Type: OTHER

Face care product

The topical product will be applied twice daily (morning and night).

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Healthy female and male volunteers aged 40 to 65 years with no signs of skin disorders.
• Subject is willing and able to read, understand, and provide written Informed Consent and signed photo release.
• Subject has a score of 3.0 to 6.0 for clinically graded visible facial wrinkles using the Fitzpatrick Classification of Facial Wrinkling scale at Baseline, to determine eligibility for the creams or serum test articles or 3.0 to 6.0 for clinically graded visible wrinkles in the eye area using a wrinkling scale for the eye cream test article.
• Subject is willing to refrain from applying/using moisturizer, creams, serums or treatment/anti-aging products to their face during the three days prior to Visit 1 (Baseline). Subject's other regular skin products such as cleanser, sunscreen and cosmetics are acceptable.
• Subject is willing to come to the test facility with a clean face free of makeup and sunscreen prior to all visits.
• Subject is a regular sunscreen user (uses at least 2 times a week).
• Subject is willing to avoid direct sun exposure and/or to apply sunscreen to their face in the event of sun exposure.
• Subject agrees to remove jewelry and false eye lashes before the visits.
• Subject agrees not to introduce any new personal care products or cosmetics to the face while participating on the study.
• Subject is willing to avoid use of tanning beds and any use of sunless tanners on the face throughout the study.
• Subject is willing to follow study instructions and available to attend all the study visits.
• Male only: Male subjects are willing to come to all visits with a clean-shaven face. Goatee and/or mustache are acceptable.

Exclusion Criteria

• Female only: Pregnant or lactating or planning a pregnancy during the course of the study. (self-reported).
• Piercing or tattoos including permanent or semi-permanent make-up on the face which may interfere with study assessments.
• Any conditions on the face that would interfere with evaluations (i.e. full beard, scars, open cuts, sunburn, severe hyperpigmentation, facial hair/peach fuzz, etc.) or active acne or acne marks.
• Any skin conditions such as rosacea, eczema, psoriasis, seborrheic dermatitis, vitiligo, etc., or is under the treatment of a doctor for any skin condition on the face.
• Use of a self-tanner/stain on the face within two weeks of the study start.
• Allergies or sensitivities to facial moisturizer products, similar materials or their ingredients or cosmetics.
• Insulin-dependent diabetes.
• Hematological or immune deficiency disease such as HIV positive, AIDS, Systemic Lupus Erythematosus.
• Recent use within the last 14 days of a chemical peel or is currently using an in-home or professional chemical peel on their facial skin.
• Subject has had a cosmetic medical procedure in the test area such as injectable anti-wrinkle products (e.g. Botox), facial cosmetic surgery, etc. in the last year.
• Current use of OTC (over the counter) pain medication ingested in quantities exceeding label use.
• Use of topical treatments such as OTC (over-the-counter) acne medication, hydroquinone, or hydrocortisone on the face in the last month.
• Currently participating in another clinical study or trial involving the face.
• Subject has been diagnosed with any type of cancer especially skin cancer within the past 12 months or treated for cancer in the last 5 years.
• Subject has any medical condition which, in the opinion of the Investigator, would compromise the safety of the subject or confound study results.

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Princeton Consumer Research

OTHER

Sponsor Role: collaborator

Amazentis SA

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Nalini Kaul, PhD

Role: PRINCIPAL_INVESTIGATOR

Princeton Consumer Research Corp.

Locations

Princeton Consumer Research Corp.

Winnipeg, Manitoba, Canada

Countries

Canada

Other Identifiers

ASACLI1W

Identifier Type: -

Identifier Source: org_study_id