Clinical trial NCT06852742: A Study to Evaluate and Compare the Efficacy of Two Facial Creams on Moderately to Severely Photodamaged Skin
Official title: A Randomized, Evaluator-Blind, Twelve-Week Usage Study to Evaluate and Compare the Efficacy of Two Facial Creams on Moderately to Severely Photodamaged Skin
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Photodamaged Skin
Lead sponsor: Johnson & Johnson Consumer and Personal Products Worldwide
Sponsor class: INDUSTRY
First posted: 2025-02-28
Enrollment: 70
Sex: FEMALE
Minimum age (years): 35
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.


Eligibility criteria: 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

Primary outcomes:
measure: Clinical Efficacy Assessment
timeFrame: Visit 5 (Day 84 ± 3)
measure: Cutaneous Tolerance Assessment
timeFrame: Visit 3 (Day 28 ± 3)
Secondary outcomes:
measure: Clinical Efficacy Assessment
timeFrame: Visit 3 (Day 28 ± 3); Visit 4 (Day 56± 3);
measure: Clinical Efficacy Assessment
timeFrame: Visit 3 (Day 28 ± 3); Visit 4 (Day 56± 3); Visit 5 (Day 84 ± 3)
measure: Cutaneous Tolerance Assessment
timeFrame: Visit 3 (Day 28 ± 3); Visit 4 (Day 56± 3); Visit 5 (Day 84 ± 3)
measure: Cutaneous Tolerance Assessment
timeFrame: Visit 4 (Day 56± 3); Visit 5 (Day 84 ± 3)
measure: Self-Assessment
timeFrame: Visit 3 (Day 28 ± 3); Visit 4 (Day 56± 3); Visit 5 (Day 84 ± 3)
measure: Product Assessment
timeFrame: Visit 3 (Day 28 ± 3); Visit 4 (Day 56± 3); Visit 5(Day 84 ± 3)
Other outcomes:
Locations:
city: West Chester
country: United States
facility: KGL Skin Study Center, LLC
state: Pennsylvania
Study officials:
References: