A Study to Evaluate and Compare the Efficacy of Two Facial Creams on Moderately to Severely Photodamaged Skin

Johnson & Johnson (J&J)

Status

Active, not recruiting

Conditions

Photodamaged Skin

Treatments

Other: Facial Cream B

Other: Facial Cream A

Study type

Interventional

Funder types

Industry

Identifiers

NCT06852742

CS2024SK100190

Details and patient eligibility

About

The objective of this study is to evaluate the efficacy of a retinol alternative-containing facial cream in improving skin texture, radiance/brightness, and the appearance of fine lines, wrinkles, uneven skin tone, and dark spots, with a positive control of a retinol-containing cream.

Enrollment

70 estimated patients

Sex

Female

Ages

35 to 60 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Fitzpatrick Skin Type I, II, III, or IV
Final review of eligibility (Visit 2): Exhibits moderate to severe (score of 4-7 on a 0-9-point scale) overall photodamage on her face, as evaluated by the PI at Visit 2
Final review of eligibility (Visit 2): Has a score of at least 4-7 (moderate to severe, on a 0-9-point scale) on at least 3 of the 5 following clinical grading parameters on her face, as evaluated by the PI at Visit 2:

i. Global fine lines ii. Wrinkles (under-eye and/or crow's feet) iii. Tactile surface roughness iv. Overall unevenness of skin tone v. Lack of radiance/brightness vi. Lack of skin firmness (look and/or feel)
Generally in good health
Able to read, write, speak, and understand English
Individual has signed the Consent for Photograph Release and ICD including Health Insurance Portability and Accountability Act disclosure
Intends to complete the study and is willing and able to follow all study instructions

Exclusion criteria

Has known allergies or adverse reactions to common topical skincare products or ingredients in the investigational study materials
Has a pre-existing or dormant facial dermatologic condition that, in the PI or designee's opinion, may confound the study results or otherwise be inappropriate for study participation (e.g., severe acne, acne conglobata, psoriasis, rosacea, rashes, eczema, atopic dermatitis, skin cancer, many and/or severe excoriations, observable suntan/sunburn, scars, nevi, tattoo, excessive hair, etc.)
Has self-perceived very sensitive skin
Has self-reported Type 1 or Type 2 diabetes or is taking insulin or another anti-diabetic medication.
Is taking a medication/using a product that would mask an Adverse Event or confound the study results
Is self-reported to be pregnant, lactating, or planning to become pregnant during the study or within 30 days of study completion
Has a history of or a concurrent health/other condition/situation which, in the opinion of the PI, may put the individual at significant risk, confound the study results, or interfere significantly with the individual's participation in the study
Has a surgery and/or invasive medical procedure planned during the study
Is simultaneously participating in any other study or has participated in any study within 30 days prior to Visit 1
Is an employee/contractor or immediate family member of the PI, Study Site, or Sponsor