Photodamaged SkinNCT06852742
A Study to Evaluate and Compare the Efficacy of Two Facial Creams on Moderately to Severely Photodamaged Skin
A study testing Facial Cream A and Facial Cream B in people with Photodamaged Skin, run by Johnson & Johnson Consumer Inc. (J&JCI) at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 35 to 60 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Photodamaged Skin
- What is being tested?
- Facial Cream A and Facial Cream B
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 69 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Jan 2025to 1 May 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 60 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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:
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
KGL Skin Study Center, LLC
West Chester, Pennsylvania, 19073
About this study
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
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
- Being tested
- Facial Cream A, Facial Cream B
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Facial Cream AOther
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.
Facial Cream BOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Facial Cream B |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Visit 3 (Day 28 ± 3)
Secondary outcomes (6)
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.
Measured: Visit 3 (Day 28 ± 3); Visit 4 (Day 56± 3);
Clinical Efficacy Assessment
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.
Measured: Visit 3 (Day 28 ± 3); Visit 4 (Day 56± 3); Visit 5 (Day 84 ± 3)
Cutaneous Tolerance Assessment
Change from baseline on edema and itching. 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.
Measured: Visit 3 (Day 28 ± 3); Visit 4 (Day 56± 3); 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.
Measured: Visit 4 (Day 56± 3); Visit 5 (Day 84 ± 3)
Self-Assessment
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.
Measured: Visit 3 (Day 28 ± 3); Visit 4 (Day 56± 3); Visit 5 (Day 84 ± 3)
Product Assessment
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.
Measured: Visit 3 (Day 28 ± 3); Visit 4 (Day 56± 3); Visit 5(Day 84 ± 3)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2025
- Study start20 Jan 2025
- Primary completion1 May 2025
- Study completion1 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Photodamaged SkinStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 69 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johnson & Johnson Consumer Inc. (J&JCI)
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06852742
- Sponsor's protocol ID
- CS2024SK100190
- Status last verified
- Jul 2025
- First submitted
- 28 Jan 2025
- Last updated
- 4 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06852742
- Acronym / sponsor ID
- CS2024SK100190
- Conditions
- Photodamaged Skin
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 69 participants (actual)
- Lead sponsor
- Johnson & Johnson Consumer Inc. (J&JCI)Industry (pharma, biotech, devices)
- Study start
- 20 Jan 2025 (actual)
- Primary completion
- 1 May 2025 (actual)
- Study completion
- 1 May 2025 (actual)
- First posted
- 28 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1: Facial Cream A (Cell A) | Experimental | Other: Facial Cream AEach subject will be provided with the assigned IP (Facial Cream A) and the APs to use for 12 weeks. |
| Arm 2: Facial Cream B (Cell B) | Experimental | Other: Facial Cream BEach subject will be provided with the assigned IP (Facial Cream B) and the APs to use for 12 weeks. |
Who may qualify
- Ages
- 35 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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:
- Generally in good health
- Able to read, write, speak, and understand English
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Facial Cream AThe 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. | Other | Arm 1: Facial Cream A (Cell A) |
| Facial Cream BThe 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. | Other | Arm 2: Facial Cream B (Cell B) |
Primary outcome
Clinical Efficacy Assessment
Time frame: 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
Time frame: 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.
6 secondary outcomes
Clinical Efficacy Assessment
Time frame: Visit 3 (Day 28 ± 3); Visit 4 (Day 56± 3);
Clinical Efficacy Assessment
Time frame: Visit 3 (Day 28 ± 3); Visit 4 (Day 56± 3); Visit 5 (Day 84 ± 3)
Cutaneous Tolerance Assessment
Time frame: Visit 3 (Day 28 ± 3); Visit 4 (Day 56± 3); Visit 5 (Day 84 ± 3)
Cutaneous Tolerance Assessment
Time frame: Visit 4 (Day 56± 3); Visit 5 (Day 84 ± 3)
Self-Assessment
Time frame: Visit 3 (Day 28 ± 3); Visit 4 (Day 56± 3); Visit 5 (Day 84 ± 3)
Product Assessment
Time frame: Visit 3 (Day 28 ± 3); Visit 4 (Day 56± 3); Visit 5(Day 84 ± 3)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jul 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Facial Cream A and Facial Cream B in people with Photodamaged Skin, run by Johnson & Johnson Consumer Inc. (J&JCI) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical Efficacy Assessment (time frame: Visit 5 (Day 84 ± 3)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jul 2025.