Acne VulgarisNCT07224633
A Clinical In-Use Evaluation to Assess the Tolerability and Efficacy of a Moisturizer on Acne Prone Skin
A study testing Use of Barrier Building Moisturizer in people with Acne Vulgaris, run by Kenvue Brands LLC at 1 site in United States.
Trial summary
The objective of this study is to evaluate the tolerance and efficacy of a facial moisturizer in subjects with mild to moderate acne vulgaris over a 4-week treatment period. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Acne Vulgaris
- What is being tested?
- Use of Barrier Building Moisturizer
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 47 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Oct 2025to 16 Dec 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 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Fitzpatrick Skin Type of I to VI, targeting the following:
- Skin types I, II, III, or IV: 60-70% of enrolled subjects
- Skin types V or VI: 30-40% of enrolled subjects
- Has acne as determined by PI and is undergoing current stable, daily treatment of acne for at least one month prior to study initiation.
- Treatments may include but are not limited to, either prescription or over-the counter products, such as: Benzoyl Peroxide, Retinoids (Adapalene, Tretinoin, Tazarotene), Topical Antibiotics and oral antibiotics (if used at least 30 days prior to Visit 1), Topical Dapsone, and Epiduo. Note: use of oral isotretinoin (Accutane) is prohibited. Targeting up to 20 subjects currently using a prescription treatment.
- Willing to continue his/her normal course of treatment (used at least 30 days prior to Visit 1), for their skin condition with no changes during the study.
Show all 10Show fewer
- Generally, in good health based on medical history reported by the subject.
- Able to read, write, speak, and understand English
- Individuals have signed the ICD including the photo release and Health Insurance Portability and Accountability Act (HIPAA) disclosure
- Intends to complete the study and is willing and able to follow the subject responsibilities.
Who cannot join
- Has severely sensitive skin and/or has known allergies or adverse reactions to common topical skincare products or to ingredients in the IP or has demonstrated a previous hypersensitivity reaction to any of the ingredients in the IP.
- Has a clinically significant, unstable medical disorder(s)
- Is unwilling or unable to comply with the requirements of the protocol.
- Has a history of a psychological illness or condition that would interfere with their ability to understand and follow the requirements of the study.
- Has any surgery and/or invasive medical procedure planned during the course of the study.
- Has started a hormone replacement therapy (HRT) or hormonal birth control less than 3 months prior to Visit 1 or plans on starting, stopping, or changing doses of HRT or hormonal birth control during the study
Show all 21Show fewer
- Presents with 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, rashes, skin cancer, many and/or severe excoriations, observable suntan, scars, nevi, tattoo, excessive hair, etc.)
- Has self-reported Type 1 or Type 2 diabetes or is taking insulin or another anti-diabetic medication.
- Is taking/using medications or a product that would mask an adverse event (AE) or influence the study results, including:
- Steroidal drugs within 2 months before Visit 1
- Non-steroidal anti-inflammatory drugs within 5 days before Visit 1
- Antihistamines within 2 weeks before Visit 1
- Oral isotretinoin (Accutane) within 6 months to Visit 1
- Anticancer and immunosuppressive treatments/medications (e.g., azathioprine, belimumab, cyclophosphamide, Enbrel, Imuran, Humira, mycophenolate mofetil, methotrexate, Remicade, Stelara) currently or within 3 months before Visit 1
- Radiation currently or within 1 week before Visit 1
- Has a history of or a concurrent health 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 history of immunosuppression/immune deficiency disorders (including HIV infection or AIDS).
- Is participating in or planning to receive any professional or aesthetic facial spa procedures during the study.
- Is simultaneously participating in any other product-use study or has participated in any clinical study on the face in the past 4 weeks.
- Is an employee/contractor or immediate family member of the PI, Study Site, or Sponsor.
- Is self-reported to be pregnant, breastfeeding, or planning to become pregnant during the study or within 30 days of study completion.
Trial locations and contacts
1 site in 1 country.
United States1 site
TKL Research Inc. - Fair Lawn
Fair Lawn, New Jersey, 07410
About this study
The objective of this study is to evaluate the tolerance and efficacy of a facial moisturizer in subjects with mild to moderate acne vulgaris over a 4-week treatment period.
- Conditions
- Acne Vulgaris
- Being tested
- Use of Barrier Building Moisturizer
- Medical subject headings
- Acne Vulgaris
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Use of Barrier Building MoisturizerOther
Subjects will use the facial moisturizer for 4 weeks according to the following: Apply evenly to your face and neck once daily (or twice daily, if desired) after washing your face with your regularly used facial cleanser for the duration of the study. Record all product applications in the daily diary.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group: Moisturizer Use | Experimental | Not described Receives: Other: Use of Barrier Building Moisturizer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Investigator's assessment of efficacy
The Investigator or the expert grader observed efficacy parameters like Visual Dryness, Tactile Surface Roughness, Lack of Radiance/Brightness, Global Fine Lines, Overall Appearance of Pores, Overall Skin Appearance, Skin Blotchiness, Uneven Skin Tone, Lack of Skin Clarity using a 10-point ordinal scale (0=none, 1-3 = mild, 4-6 = moderate, 7-9 = severe).
A decrease in score compared to baseline indicates an improvement in the efficacy parameter.
Measured: Visit 1 (Screening/Baseline: pre-product use), Visit 2 (Week 1) and Visit 3 (Week 4)
Acne Quality of Life Index (AQOLI) 3 Domains and Group Total Scores
Subjects will complete an Acne Quality of Life Index [Acne-QOLI] using a 1 to 7 scale (1 = extremely, 4 = some, 7 = not at all).
A decrease in scores indicates improvement.
Measured: Visit 1 (Screening/Baseline: pre-product use) and Visit 3 (Week 4)
VISIA Imaging
Full-face digital images will be taken using the site provided VISIA-CR 5 photographic imaging system.
Measured: Visit 1 (Screening/Baseline: pre-product use) and Visit 3 (Week 4)
Investigator's assessment of tolerability
The Investigator will perform a clinical evaluation of each subject's neck and facial skin of Erythema, Edema, Dryness/Scaling, Rash/Irritation using a 4-point ordinal scale (0=none; 1=Mild; 2=Moderate; 3=Severe).
A decrease in score compared to baseline indicates an improvement in the efficacy parameter.
Measured: Visit 1 (Screening/Baseline: pre-product use),Visit 2(Week 1) and Visit 3 (Week 4)
Subjects' assessment of tolerability
The Investigator will question each subject for the parameters below regarding the subject's neck and facial skin of Burning, Stinging, Tightness/Dry Feeling , Itching , Peeling/Flaking, Overall sensitivity. Assessments will be scored on a 4-point ordinal scale (0=none; 1=Mild; 2=Moderate; 3=Severe).
A decrease in score compared to baseline indicates an improvement in the efficacy parameter.
Measured: Visit 1 (Screening/Baseline: pre-product use), Visit 2 (Week 1), and Visit 3 (Week 4)
Subjective assessment of efficacy Part A
Self-assessment regarding the current condition (Appearance of redness associated with pimples, Oiliness of skin, Shininess of skin, Dryness of skin, Flakiness of skin, Skin smoothness, Appearance of pores, Redness of skin, Overall appearance of skin) of facial skin using a 1-10 scale.
A decrease in score indicates an improvement in the efficacy parameter.
Measured: Visit 1 (Screening/Baseline: pre-product use), Visit 2 (Week 1) and Visit 3 (Week 4)
Subjective assessment of efficacy Part B
Self-assessment on efficacy at post product use timepoint. Frequency and percentage of all answers for all questions, and a binomial test (sign test) p-value will be provided for applicable questions.
A higher percentage of favorable responses with a significant p-value indicates positive subject perceptions of the IP.
Measured: Visit 1 (Post product use), Visit 2 (Week 1) and Visit 3 (Week 4)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2025
- Study start7 Oct 2025
- Primary completion16 Dec 2025
- Study completion16 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acne VulgarisStudies 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
- Not applicable
- Intervention model
- Single group
- Model description
- This is a single-center, monadic clinical study. This study is not randomized or blinded. All subjects will be testing the same IP.
- Masking
- None (open label)
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kenvue Brands LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07224633
- Sponsor's protocol ID
- CS2025SK100252
- Status last verified
- 4 Aug 2026
- First submitted
- 1 Nov 2025
- Last updated
- 19 Aug 2026
- 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 19 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical In-Use Evaluation to Assess the Tolerability and Efficacy of a Moisturizer on Acne Prone Skin
- ClinicalTrials.gov ID
- NCT07224633
- Acronym / sponsor ID
- CS2025SK100252
- Conditions
- Acne Vulgaris
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- Kenvue Brands LLCIndustry (pharma, biotech, devices)
- Study start
- 7 Oct 2025 (actual)
- Primary completion
- 16 Dec 2025 (actual)
- Study completion
- 16 Dec 2025 (actual)
- First posted
- 5 Nov 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 tolerance and efficacy of a facial moisturizer in subjects with mild to moderate acne vulgaris over a 4-week treatment period.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is a single-center, monadic clinical study. This study is not randomized or blinded. All subjects will be testing the same IP.
| Arm | Type | Receives |
|---|---|---|
| Experimental group: Moisturizer Use | Experimental | Other: Use of Barrier Building Moisturizer |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- Fitzpatrick Skin Type of I to VI, targeting the following:
- Has acne as determined by PI and is undergoing current stable, daily treatment of acne for at least one month prior to study initiation.
- Willing to continue his/her normal course of treatment (used at least 30 days prior to Visit 1), for their skin condition with no changes during the study.
- Generally, in good health based on medical history reported by the subject.
- Able to read, write, speak, and understand English
Key exclusion criteria (21 listed)
- Has severely sensitive skin and/or has known allergies or adverse reactions to common topical skincare products or to ingredients in the IP or has demonstrated a previous hypersensitivity reaction to any of the ingredients in the IP.
- Has a clinically significant, unstable medical disorder(s)
- Is unwilling or unable to comply with the requirements of the protocol.
- Has a history of a psychological illness or condition that would interfere with their ability to understand and follow the requirements of the study.
- Has any surgery and/or invasive medical procedure planned during the course of the study.
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 |
|---|---|---|
| Use of Barrier Building MoisturizerSubjects will use the facial moisturizer for 4 weeks according to the following: Apply evenly to your face and neck once daily (or twice daily, if desired) after washing your face with your regularly used facial cleanser for the duration of the study. Record all product applications in the daily diary. | Other | Experimental group: Moisturizer Use |
Primary outcome
Investigator's assessment of efficacy
Time frame: Visit 1 (Screening/Baseline: pre-product use), Visit 2 (Week 1) and Visit 3 (Week 4)
The Investigator or the expert grader observed efficacy parameters like Visual Dryness, Tactile Surface Roughness, Lack of Radiance/Brightness, Global Fine Lines, Overall Appearance of Pores, Overall Skin Appearance, Skin Blotchiness, Uneven Skin Tone, Lack of Skin Clarity using a 10-point ordinal scale (0=none, 1-3 = mild, 4-6 = moderate, 7-9 = severe). A decrease in score compared to baseline indicates an improvement in the efficacy parameter.
Acne Quality of Life Index (AQOLI) 3 Domains and Group Total Scores
Time frame: Visit 1 (Screening/Baseline: pre-product use) and Visit 3 (Week 4)
Subjects will complete an Acne Quality of Life Index [Acne-QOLI] using a 1 to 7 scale (1 = extremely, 4 = some, 7 = not at all). A decrease in scores indicates improvement.
VISIA Imaging
Time frame: Visit 1 (Screening/Baseline: pre-product use) and Visit 3 (Week 4)
Full-face digital images will be taken using the site provided VISIA-CR 5 photographic imaging system.
Investigator's assessment of tolerability
Time frame: Visit 1 (Screening/Baseline: pre-product use),Visit 2(Week 1) and Visit 3 (Week 4)
The Investigator will perform a clinical evaluation of each subject's neck and facial skin of Erythema, Edema, Dryness/Scaling, Rash/Irritation using a 4-point ordinal scale (0=none; 1=Mild; 2=Moderate; 3=Severe). A decrease in score compared to baseline indicates an improvement in the efficacy parameter.
Subjects' assessment of tolerability
Time frame: Visit 1 (Screening/Baseline: pre-product use), Visit 2 (Week 1), and Visit 3 (Week 4)
The Investigator will question each subject for the parameters below regarding the subject's neck and facial skin of Burning, Stinging, Tightness/Dry Feeling , Itching , Peeling/Flaking, Overall sensitivity. Assessments will be scored on a 4-point ordinal scale (0=none; 1=Mild; 2=Moderate; 3=Severe). A decrease in score compared to baseline indicates an improvement in the efficacy parameter.
Subjective assessment of efficacy Part A
Time frame: Visit 1 (Screening/Baseline: pre-product use), Visit 2 (Week 1) and Visit 3 (Week 4)
Self-assessment regarding the current condition (Appearance of redness associated with pimples, Oiliness of skin, Shininess of skin, Dryness of skin, Flakiness of skin, Skin smoothness, Appearance of pores, Redness of skin, Overall appearance of skin) of facial skin using a 1-10 scale. A decrease in score indicates an improvement in the efficacy parameter.
Subjective assessment of efficacy Part B
Time frame: Visit 1 (Post product use), Visit 2 (Week 1) and Visit 3 (Week 4)
Self-assessment on efficacy at post product use timepoint. Frequency and percentage of all answers for all questions, and a binomial test (sign test) p-value will be provided for applicable questions. A higher percentage of favorable responses with a significant p-value indicates positive subject perceptions of the IP.
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 19 Aug 2026.
- Individual participant dataSharing planned: No
Related trials for Acne Vulgaris
Not yet recruitingPhase 3
Evaluation of the Efficacy and Safety of Fractional CO₂ Laser With and Without Intradermal Botulinum Toxin A in the Treatment of Inflammatory Facial Acne Vulgaris.
Acne, Acne Papulopustulosa
RecruitingPhase 4
Safety, Tolerability, and Clinical Effectiveness of Adapalene/Clindamycin Phosphate Gel (Klenzit®-C) in Vietnamese Patients With Mild to Moderate Acne Vulgaris
Acne
RecruitingPhase 3
Phase 3 Study of Denifanstat in Participants With Moderate to Severe Acne (AURORA)
Acne Vulgaris
RecruitingPhase 4
Comparing Nadifloxacin Plus Tretinoin Versus Clindamycin Plus Tretinoin Creams for Mild-to-Moderate Acne
Acne Vulgaris
Active, not recruiting
Clinical Study to Evaluate the Safety and Efficacy of Candela Technology
Hair Reduction, Tattoo Removal
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 Use of Barrier Building Moisturizer in people with Acne Vulgaris, run by Kenvue Brands LLC 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 10 inclusion and 21 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 19 Aug 2026. 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?
Investigator's assessment of efficacy (time frame: Visit 1 (Screening/Baseline: pre-product use), Visit 2 (Week 1) and Visit 3 (Week 4)). The study lists 7 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 19 Aug 2026.