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

Not Applicable

Completed

• Conditions: Photodamaged Skin

• Registration Number: NCT06852742
• Lead Sponsor: Johnson & Johnson Consumer Inc. (J&JCI)

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2025-01-20
• Study First Submitted: 2025-01-28
• Study First Submitted QC: 2025-02-24
• Study First Posted: 2025-02-28
• Primary Completion: 2025-05-01
• Study Completion: 2025-05-01
• Status Verified: 2025-07
• Last Update Submitted: 2025-07-02
• Last Update Posted: 2025-07-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 69

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Clinical Efficacy Assessment	Visit 5 (Day 84 ± 3)	Change from baseline on global fine lines, under-eye wrinkles, and crow's feet wrinkles by clinical evaluation. The Principal Investigator will assess each subject's facial condition for the appearance of the mentioned signs on a scale of 0-9, where 0=none, 1-3=mild, 4-6=moderate and 7-9=severe.
Cutaneous Tolerance Assessment	Visit 3 (Day 28 ± 3)	Change from baseline on erythema, dryness/scaling, burning/stinging, and feeling of dryness/tightness. The Principal Investigator will assess each subject's facial condition for the appearance of the mentioned signs on a scale of 0-3, where 0=none, 1=mild, 2=moderate and 3=severe.

Secondary Outcome Measures

Name	Time	Method
Clinical Efficacy Assessment	Visit 3 (Day 28 ± 3); Visit 4 (Day 56± 3); Visit 5 (Day 84 ± 3)	Change from baseline on Tactile surface roughness; Lack of clarity; Lack of global firmness (look); Lack of global skin firmness (feel); Elasticity (pinch recoil evaluation);Overall unevenness of skin tone (brown tones); Lack of radiance/brightness; Overall photodamage; Mottled hyperpigmentation; Discrete pigmentation; Skin elasticity/resiliency via pinch-recoil measurement. The Principal Investigator will assess each subject's facial condition for the appearance of the mentioned signs on a scale of 0-9, where 0=none, 1-3= mild, 4-6=moderate and 7-9=severe. For Skin elasticity/resiliency, the Principal Investigator will pinch the skin at the test site between the thumb and middle finger, hold the skin in place for approximately two seconds, and then note the time for the skin to return to its original conformation. A decrease in pinch-recoil times indicates an increase in skin elasticity/resiliency.
Cutaneous Tolerance Assessment	Visit 4 (Day 56± 3); Visit 5 (Day 84 ± 3)	Change from baseline on erythema, dryness/scaling, burning/stinging, and feeling of dryness/tightness. The Principal Investigator will assess each subject's facial condition for the appearance of the mentioned signs on a scale of 0-3, where 0=none, 1=mild, 2=moderate and 3=severe.
Self-Assessment	Visit 3 (Day 28 ± 3); Visit 4 (Day 56± 3); Visit 5 (Day 84 ± 3)	Participant's self-assessment questionnaire to assess the facial skin condition. Participants will answer six questions and rate their responses on a scale from 1 to 10, where a higher score indicates a more positive response.
Product Assessment	Visit 3 (Day 28 ± 3); Visit 4 (Day 56± 3); Visit 5(Day 84 ± 3)	Product assessment questionnaire to assess the percentage of favorable responses compared to unfavorable responses. Participants will answer 23 questions and rate as: Disagree completely, disagree somewhat, neither agree nor disagree, agree somewhat and agree completely.

Trial Locations

Locations (1)

KGL Skin Study Center, LLC; 🇺🇸 West Chester, Pennsylvania, United States