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

NCT06852742 | Completed

• 1 other identifier: CS2024SK100190
• Study Type: interventional
• Target: 69
• Locations: 1 country
• Sites: 1

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.

Conditions

Photodamaged Skin

Outcome Measures

Primary Outcomes (2)

• Clinical Efficacy Assessment

  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.

  Visit 5 (Day 84 ± 3)

• Cutaneous Tolerance Assessment

  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.

  Visit 3 (Day 28 ± 3)

Secondary Outcomes (6)

• Clinical Efficacy Assessment

  Visit 3 (Day 28 ± 3); Visit 4 (Day 56± 3);

• Clinical Efficacy Assessment

  Visit 3 (Day 28 ± 3); Visit 4 (Day 56± 3); Visit 5 (Day 84 ± 3)

• Cutaneous Tolerance Assessment

  Visit 3 (Day 28 ± 3); Visit 4 (Day 56± 3); Visit 5 (Day 84 ± 3)

• Cutaneous Tolerance Assessment

  Visit 4 (Day 56± 3); Visit 5 (Day 84 ± 3)

• Self-Assessment

  Visit 3 (Day 28 ± 3); Visit 4 (Day 56± 3); Visit 5 (Day 84 ± 3)

Study Arms (2)

Arm 1: Facial Cream A (Cell A)

EXPERIMENTAL

Each subject will be provided with the assigned IP (Facial Cream A) and the APs to use for 12 weeks.

Other: Facial Cream A

Arm 2: Facial Cream B (Cell B)

EXPERIMENTAL

Each subject will be provided with the assigned IP (Facial Cream B) and the APs to use for 12 weeks.

Other: Facial Cream B

Interventions

Facial Cream A OTHER

The participants will use the Facial Cleanser twice daily (morning and evening). The Facial Cream A will be applied topically evenly over the entire face after cleansing and drying face in the morning and in the evening. The Sunscreen will be applied evenly over the entire face after Facial Cream A in the morning and re-applied after 80 minutes of swimming or sweating, immediately after towel drying, and at least every 2 hours during sun exposure.

Arm 1: Facial Cream A (Cell A)

Facial Cream B OTHER

The participants will use the Facial Cleanser twice daily (morning and evening).The Sunscreen will be applied evenly over the entire face after cleansing in the morning and re-applied after 80 minutes of swimming or sweating, immediately after towel drying, and at least every 2 hours during sun exposure. The Facial Cream B will be applied in the evening after washing and drying face.

Arm 2: Facial Cream B (Cell B)

Eligibility Criteria

• Age: 35 Years - 60 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Johnson & Johnson Consumer Inc. (J&JCI): lead

Study Sites (1)

KGL Skin Study Center, LLC

West Chester, Pennsylvania, 19073, United States

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 28, 2025
• First Posted: February 28, 2025
• Study Start: January 20, 2025
• Primary Completion: May 1, 2025
• Study Completion: May 1, 2025
• Last Updated: July 4, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)