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Plaque PsoriasisPhase 4NCT06357221

A Study to Assess Efficacy and Tolerability of Topical Skincare Products on Psoriasis Patients

A Phase 4 study testing Cetaphil in people with Plaque Psoriasis and Psoriasis, run by Galderma R&D at 3 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Subjects having mild-to-severe plaque psoriasis, with active target lesion plaques, and currently on or starting a prescription treatment for plaque psoriasis will apply a topical skincare regimen to one side of the body. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Plaque Psoriasis, Psoriasis
What is being tested?
Cetaphil
Could I receive a placebo?
No, everyone receives an active treatment
How many people
46 participants
Where
3 sitesUnited States
Study dates
8 Apr 2024to 18 Jul 2024
Phase
Phase 4
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Adult subjects aged 18 years and above
  • Females or males
  • Any Fitzpatrick skin types I-VI, with effort to include n = 2 for each category
  • Any races, with effort to include minimum 10% minority (n = 4) such as American Indian or Alaska Native, Eastern/Southeastern Asian, South Asians, Black or African American, Native Hawaiian or Other Pacific Islander.
  • Any ethnicities, with effort to include minimum 10% (n = 4) of Hispanic, Latino, or Spanish origin
  • Having active target lesion plaques, with minimum area of 2 cm x 2 cm
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  • Having mild-to-severe plaque psoriasis with at least 3% Body Surface Area (BSA) and cumulative Target Lesion Severity Score (TLSS) ≥ 6.
  • Currently on or starting a plaque psoriasis prescription treatment such as biologics, oral or topical therapy for psoriasis, or UV therapy.
  • Subject in general good health
  • Subject willing to stop using current topical skincare products during the duration of the study.
  • Subject willing to replace current skincare products with study products for the duration of the study.
  • For female subjects of childbearing potential, she must not be pregnant, breastfeeding or planning pregnancy during the course of the study. Subjects must be willing to take a urine pregnancy test (UPT) at Baseline visit. (Females of non-childbearing potential, e.g., post-menopausal (absence of menstrual bleeding for 1 year without any other medical reason), hysterectomy, or bilateral ovariectomy, are not required to have a UPT.)
  • Ability of giving consent for participation in the study
  • Willing to sign a photography release, with minimum 80% of total study panel
  • Agreement to adhere to the procedures and requirements of the study and to report to the site on the day(s) and at the time(s) scheduled for the assessments

Who cannot join

  • Pregnant, breastfeeding, or planning pregnancy during the course of the study.
  • Subjects with any known allergies or hypersensitivity to any cosmetics, personal care products, and/or fragrances.
  • History of cancer within the past 5 years
  • History or presence of any skin condition/disease, besides plaque psoriasis, that might interfere with the diagnosis or evaluation of study parameters at the discretion of the investigator.
  • Planning on having surgeries and/or invasive medical procedures during the course of the study
  • Treatment with chemotherapy, immunosuppressive agents, prescription corticosteroids for psoriasis, immunomodulatory therapy (e.g., monoclonal antibodies or antiviral treatment for human immunodeficiency virus or hepatitis C)
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  • History or presence of any medical condition that, in the opinion of the Investigator, would make the subject unsuitable for inclusion (e.g., a chronic, relapsing, or hereditary disease that may interfere the outcome of the study).
  • Other condition preventing the subject from entering the study in the Investigator's opinion, (e.g., subjects failing baseline assessments, subjects not likely to avoid other treatments in the treated areas, subjects anticipated to be unavailable or incapable of understanding the study assessments or having unrealistic expectations of the treatment result).
  • Study site personnel, close relatives of the study site personnel (e.g., parents, children, siblings, or spouse), or employees and close relatives of employees at the Sponsor company.
  • Participation in any interventional clinical study within 30 days of screening or planning to participate in another interventional clinical research study while enrolled in this trial.

Trial locations and contacts

3 sites in 1 country.

United States3 sites
  • Southeast Dermatology Specialists, LLC

    Columbus, Georgia, 31904

  • Southeast Dermatology Specialists, LLC

    Douglasville, Georgia, 30135

  • Dermatology Consulting Services

    High Point, North Carolina, 27262

Other trials in United States

About this study

Official title: A Multi-center, Open-label, In-use Study to Assess Efficacy and Tolerability of Topical Skincare Products on Psoriasis Patients

Subjects having mild-to-severe plaque psoriasis, with active target lesion plaques, and currently on or starting a prescription treatment for plaque psoriasis will apply a topical skincare regimen to one side of the body. Evaluations of the regimen's efficacy will be conducted at 2 weeks, 4 weeks, and 8 weeks post-baseline.

Read the detailed description

This is a multi-center, open-label, in-use study. Adult subjects having mild-to-severe plaque psoriasis, with active target lesion plaques, and currently on or starting a prescription treatment for plaque psoriasis will be recruited for participation in the study.

Subjects will report to the site at Baseline (day 0) visit, will be given an informed consent form, HIPAA form, photography release form, and medical history form to complete.

Subjects will be screened on the basis of the selection criteria for study qualification. Eligible subjects will be assessed at Baseline visit and instructed to start applying the skincare products to the assigned side of the body based on the pre-determined randomization.

Subjects to return to the site at Week 2 (± 3 days), Week 4 (± 5 days), and Week 8 (± 5 days) for follow-ups.

Being tested
Cetaphil
Medical subject headings
Psoriasis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CetaphilDrug

    Also called Topical Skincare Treatment

    Subjects will clean the skin with Cetaphil Gentle Skin Cleanser, and apply Cetaphil Moisturizing Cream to the lesion areas at least twice daily. Subjects will use Cetaphil Daily Facial Moisturizer SPF 35 as needed.

Study groups in NCT06357221
Study groupRoleWhat they receive
Skincare Product TreatmentExperimentalSubjects will use topical skincare products to assigned side of the body, per randomization.
Receives: Drug: Cetaphil

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Psoriatic Body Surface Area Compared to Baseline

    Body Surface Area is a measure of how much skin is impacted by psoriasis using the following measurement.7 One handprint is equal approximately to 1% of Body Surface Area. A decrease in scores indicated an improvement.

    Measured: Baseline, Week 2, Week 4, Week 8

  2. Change in Target Lesion Severity Compared to Baseline

    Target lesion severity was measured by the Target Lesion Severity Score. Target Lesion Severity Score assessed erythema, induration, and scaling separately on a scale of 0-8, with 0 meaning no evidence of the parameter and 8 meaning very severe presence of the parameter. Target Lesion Severity Score was calculated as cumulative total of all 3 parameters, which a maximum score of 24 (8 x 3) and minimum score of 0. Total scale range is 0-24, where higher scores are worse outcomes. A decrease in scores indicated an improvement.

    Measured: Baseline, Week 2, Week 4, Week 8

  3. Change of Physician Global Assessment Compared to Baseline

    Physician Global Assessment assessed overall severity of psoriasis on a scale of 0 to 5, with 0 meaning no presence of psoriasis and 5 meaning very severe presence of psoriasis. A decrease in scores indicated an improvement.

    Measured: Baseline, Week 2, Week 4, Week 8

  4. Change in Skin Scaliness Measured by Macroscopic Imaging

    Macroscopic imaging was performed using Visioscan® VC 20plus to take an image of the target lesion. The Visioscan software was used to calculate the analyze the images for skin scaliness (a decrease in values indicates an improvement in roughness).

    Measured: Baseline, Week 2, Week 4, Week 8

  5. Change in Skin Smoothness Measured by Macroscopic Imaging

    Macroscopic imaging was performed using Visioscan® VC 20plus to take an image of the target lesion. The Visioscan software was used to calculate the analyze the images for skin smoothness (a decrease in values indicates an improvement in skin smoothness).

    Measured: Baseline, Week 2, Week 4, Week 8

  6. Subject Treatment Satisfaction

    Subjects were asked about their perception, satisfaction, and preference with each study treatment using a self-assessment questionnaire. Questionnaires were tabulated; and the number of all response options was reported for each question and time point. Favorable responses (i.e., strongly agree and agree, yes), neutral responses (i.e., neither agree nor disagree, no difference), and unfavorable responses (i.e., strongly disagree and disagree, no) were tabulated as appropriate. Number of participants with favorable responses was provided for each question.

    Measured: Week 2

  7. Subject Treatment Satisfaction

    Subjects were asked about their perception, satisfaction, and preference with each study treatment using a self-assessment questionnaire. Questionnaires were tabulated; and the number of all response options was reported for each question and time point. Favorable responses (i.e., strongly agree and agree, yes), neutral responses (i.e., neither agree nor disagree, no difference), and unfavorable responses (i.e., strongly disagree and disagree, no) were tabulated and reported as appropriate. Number of participants with favorable responses was provided for each question.

    Measured: Week 4

  8. Subject Treatment Satisfaction

    Subjects were asked about their perception, satisfaction, and preference with each study treatment using a self-assessment questionnaire. Questionnaires were tabulated; and the number of all response options was reported for each question and time point. Favorable responses (i.e., strongly agree and agree, yes), neutral responses (i.e., neither agree nor disagree, no difference), and unfavorable responses (i.e., strongly disagree and disagree, no) were tabulated and reported as appropriate. Number of participants with favorable responses was provided for each question.

    Measured: Week 8

  9. Changes in Dryness Compared to Baseline [Tolerability Assessment]

    Tolerability assessment was performed by the Investigator (parameter: dryness) using a 4-point analog scale (with half-point scores used as necessary to better describe the clinical condition). Investigator graded the degree of irritation of target lesion areas on a scale of 0 to 3, with 0 meaning parameter is not present, and 3 meaning parameter is severely present. A decrease in scores or lack of significant increase indicated tolerability/safety of the treatment products.

    Measured: Baseline, Week 2, Week 4, Week 8

  10. Change in Burning/Stinging Compared to Baseline [Tolerability Assessment]

    Tolerability assessment was performed by subjects (parameters: burning/stinging) using a 4-point analog scale (with half-point scores used as necessary to better describe the clinical condition). subjects graded the degree of irritation of target lesion areas on a scale of 0 to 3, with 0 meaning parameter is not present, and 3 meaning parameter is severely present. A decrease in scores or lack of significant increase indicated tolerability/safety of the treatment products.

    Measured: Baseline, Week 2, Week 4, Week 8

  11. Change in Itching Compared to Baseline [Tolerability Assessment]

    Tolerability assessment was performed by subjects (parameters: itching) using a 4-point analog scale (with half-point scores used as necessary to better describe the clinical condition). Subjects graded the degree of irritation of target lesion areas on a scale of 0 to 3, with 0 meaning parameter is not present, and 3 meaning parameter is severely present. A decrease in scores or lack of significant increase indicated tolerability/safety of the treatment products.

    Measured: Baseline, Week 2, Week 4, Week 8

Secondary outcomes (1)
  1. Subject Quality of Life Satisfaction

    Subjects were asked about their life quality by completing a Quality of Life questionnaire of 10 questions. Each question is scored from 0-3, with 0 being "not at all" or "not relevant" and 3 being "very much". All scores were summed to determine the Dermatology Quality of Life Index with score range 0-30: 0-1 (no effect at all on patient's life), 2-5 (small effect), 6-10 (moderate effect), 11-20 (very large effect), 21-30 (extremely large effect). A decrease in score totals from baseline to Week 8 indicated an improvement. A higher score indicates a greater impairment of quality of life.

    Measured: Baseline, Week 8

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Apr 2024
  2. Study start8 Apr 2024
  3. Primary completion18 Jul 2024
  4. Study completion18 Jul 2024

Resources

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 4
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
46 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06357221
Sponsor's protocol ID
GLI.04.US.SL.035
Status last verified
May 2026
First submitted
20 Mar 2024
Last updated
9 Jun 2026
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Cetaphil in people with Plaque Psoriasis and Psoriasis, run by Galderma R&D at 3 sites 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 15 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 9 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites 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.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 9 Jun 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Change in Psoriatic Body Surface Area Compared to Baseline (time frame: Baseline, Week 2, Week 4, Week 8). The study lists 11 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 9 Jun 2026.

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