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CompletedNCT06357221Updated Jun 9, 2026Results posted

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

A Phase 4 interventional study of Cetaphil in Plaque Psoriasis and Psoriasis, sponsored by Galderma R&D. Completed at 3 sites in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-06-09.

Sponsored by Galderma R&D · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
46
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Plaque Psoriasis
  • Psoriasis

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03

In context

Psoriasis

1,899 studies on the registry are indexed under Psoriasis; 233 are open to participants now.

This study's enrollment of 46 is below the median of 70 across 1,447 interventional studies indexed under Psoriasis.

Browse Psoriasis studies →

Lead sponsor

Galderma R&D is the lead sponsor of 280 studies on the registry; 9 are open to participants now.

Of its 59 completed or terminated interventional studies of FDA-regulated products, 55 (93%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  1. Adult subjects aged 18 years and above
  2. Females or males
  3. Any Fitzpatrick skin types I-VI, with effort to include n = 2 for each category
  4. 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.
  5. Any ethnicities, with effort to include minimum 10% (n = 4) of Hispanic, Latino, or Spanish origin
  6. Having active target lesion plaques, with minimum area of 2 cm x 2 cm
  7. Having mild-to-severe plaque psoriasis with at least 3% Body Surface Area (BSA) and cumulative Target Lesion Severity Score (TLSS) ≥ 6.
  8. Currently on or starting a plaque psoriasis prescription treatment such as biologics, oral or topical therapy for psoriasis, or UV therapy.
  9. Subject in general good health
  10. Subject willing to stop using current topical skincare products during the duration of the study.
  11. Subject willing to replace current skincare products with study products for the duration of the study.
  12. 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.)
  13. Ability of giving consent for participation in the study
  14. Willing to sign a photography release, with minimum 80% of total study panel
  15. 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

Exclusion criteria

Exclusion Criteria:

  1. Pregnant, breastfeeding, or planning pregnancy during the course of the study.
  2. Subjects with any known allergies or hypersensitivity to any cosmetics, personal care products, and/or fragrances.
  3. History of cancer within the past 5 years
  4. 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.
  5. Planning on having surgeries and/or invasive medical procedures during the course of the study
  6. 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)
  7. 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).
  8. 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).
  9. 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.
  10. 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.
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
46 participants (actual)

Study arms

  • Experimental
    Skincare Product Treatment

    Subjects will use topical skincare products to assigned side of the body, per randomization.

    Drug: Cetaphil

Interventions

  • DrugCetaphil

    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.

    Also known as: Topical Skincare Treatment

06

What researchers measure

Primary outcomes

  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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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).

    Time frame: 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).

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: Baseline, Week 2, Week 4, Week 8

Secondary outcomes

  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.

    Time frame: Baseline, Week 8

07

Results

Posted Jun 9, 2026

Participant flow

Participant flow — Overall Study
MilestoneSkincare Product Treatment
Started46
Completed41
Not completed5

Outcome measures

PrimaryChange 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.

Time frame:
Baseline, Week 2, Week 4, Week 8
Reported as:
Mean · BSA %
Change in Psoriatic Body Surface Area Compared to Baseline
BSA %Skincare Product Treatment
Baseline9.3 ± 10.1
Week 27.55 ± 6.89
Week 47.49 ± 11.34
Week 85.1 ± 5.55
PrimaryChange 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.

Time frame:
Baseline, Week 2, Week 4, Week 8
Reported as:
Mean · Score on a scale
Change in Target Lesion Severity Compared to Baseline
Score on a scaleSkincare Product Treatment
Baseline10.85 ± 3.67
Week 27.24 ± 3.59
Week 45.34 ± 4.07
Week 83.51 ± 3
PrimaryChange 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.

Time frame:
Baseline, Week 2, Week 4, Week 8
Reported as:
Mean · Score on a scale
Change of Physician Global Assessment Compared to Baseline
Score on a scaleSkincare Product Treatment
Baseline2.67 ± 0.7
Week 22.36 ± 0.79
Week 41.73 ± 0.87
Week 81.37 ± 0.83
PrimaryChange 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).

Time frame:
Baseline, Week 2, Week 4, Week 8
Reported as:
Mean · Pixels
Change in Skin Scaliness Measured by Macroscopic Imaging
PixelsSkincare Product Treatment
Baseline10.77 ± 4.92
Week 26.78 ± 3.63
Week 45.52 ± 4.26
Week 85.71 ± 4.36
PrimaryChange 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).

Time frame:
Baseline, Week 2, Week 4, Week 8
Reported as:
Mean · Pixels
Change in Skin Smoothness Measured by Macroscopic Imaging
PixelsSkincare Product Treatment
Baseline596.43 ± 192.39
Week 2394.49 ± 169.99
Week 4376.72 ± 205.51
Week 8353.95 ± 192.12
PrimarySubject 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.

Time frame:
Week 2
Reported as:
Number · Participants with favorable responses
Subject Treatment Satisfaction
Participants with favorable responsesSkincare Product Treatment
Subjects reported the cleanser left their skin feeling clean39
Subjects reported the cleanser didn't irritate their skin38
Subjects report this cleanser didn't dry their skin out40
Subjects reported their skin felt nourished after using the regimen39
Subjects reported it was easy to incorporate this skincare regimen into daily prescription routine40
Subjects reported this moisturizer had helped the lesions feel softer40
Subjects reported the skin lesions felt smoother since starting this moisturizer36
Subjects reported their skin looked healthier since starting this moisturizer33
Subjects reported the moisturizer kept their skin feeling hydrated throughout the day38
SecondarySubject 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.

Time frame:
Baseline, Week 8
Reported as:
Mean · Score on a scale
Subject Quality of Life Satisfaction
Score on a scaleSkincare Product Treatment
Baseline9.24 ± 6.77
Week 82.85 ± 3.17
PrimarySubject 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.

Time frame:
Week 4
Reported as:
Number · Participants with favorable responses
Subject Treatment Satisfaction
Participants with favorable responsesSkincare Product Treatment
Subjects reported their skin was less dry and cracked36
Subjects reported they worried less about their skin since starting the regimen34
Subjects reported the products worked well with their prescription treatment as a complete regimen37
Subjects reported this moisturizer helped smooth out their skin's rough texture39
Subjects reported their skin appeared healthier-looking since starting this moisturizer38
Subjects reported the skin lesions felt much softer since starting this moisturizer39
Subjects reported this moisturizer had helped the lesions feel more hydrated40
Subjects reported the skin lesions looked less flaky since starting this moisturizer39
PrimarySubject 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.

Time frame:
Week 8
Reported as:
Number · Participants with favorable responses
Subject Treatment Satisfaction
Participants with favorable responsesSkincare Product Treatment
Subjects reported the cleanser was gentle for daily use on their psoriasis skin41
Subjects reported the skin felt the least irritated since starting this skincare regimen34
Subjects report their skin hadn't felt this great in a long time37
Subjects reported this was thei favorite skincare regimen34
Subjects reported this skincare regimen was the perfect choice as part of prescription regimen36
Subjects reported their skin was at the healthiest-looking state since using this moisturizer37
Subjects reported this moisturizer helped sooth my sensitive skin41
Subjects reported they loved how soft their skin felt39
Subjects reported the skin lesions had been consistently hydrated since using this moisturizer39
Subjects reported this moisturizer helped smoothen out the rough, scaly lesions40
PrimaryChanges 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.

Time frame:
Baseline, Week 2, Week 4, Week 8
Reported as:
Mean · Score on a scale
Changes in Dryness Compared to Baseline [Tolerability Assessment]
Score on a scaleSkincare Product Treatment
Baseline2.09 ± 0.72
Week 21.38 ± 0.70
Week 41.07 ± 0.98
Week 80.71 ± 0.81
PrimaryChange 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.

Time frame:
Baseline, Week 2, Week 4, Week 8
Reported as:
Mean · Score on a scale
Change in Burning/Stinging Compared to Baseline [Tolerability Assessment]
Score on a scaleSkincare Product Treatment
Baseline1.15 ± 1.05
Week 20.67 ± 0.93
Week 40.27 ± 0.67
Week 80.12 ± 0.51
PrimaryChange 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.

Time frame:
Baseline, Week 2, Week 4, Week 8
Reported as:
Mean · Score on a scale
Change in Itching Compared to Baseline [Tolerability Assessment]
Score on a scaleSkincare Product Treatment
Baseline2.04 ± 0.97
Week 20.98 ± 0.98
Week 40.68 ± 0.93
Week 80.29 ± 0.64

Adverse events

Collected over 8 weeks (i.e., from the study start to the study completion).. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Skincare Product Treatment0/46 (0%)0/46 (0%)4/46 (8.7%)
Most frequent other events
Most frequent other events
EventSkincare Product Treatment
Burning/StingingSkin and subcutaneous tissue disorders3/46
ItchySkin and subcutaneous tissue disorders1/46

Baseline characteristics

Age, Continuous
Age, Continuous(Years)Skincare Product Treatment
Mean57.2 ± 15.9
Sex: Female, Male
Sex: Female, Male(Participants)Skincare Product Treatment
Female24
Male22
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Skincare Product Treatment
American Indian or Alaska Native0
Asian1
Native Hawaiian or Other Pacific Islander0
Black or African American16
White24
More than one race5
Unknown or Not Reported0
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Skincare Product Treatment
Hispanic or Latino5
Not Hispanic or Latino41
Unknown or Not Reported0
Region of Enrollment
Region of Enrollment(Participants)Skincare Product Treatment
United States46
08

Study locations

3 sites
  • Southeast Dermatology Specialists, LLC
    Columbus, Georgia 31904, United States
  • Southeast Dermatology Specialists, LLC
    Douglasville, Georgia 30135, United States
  • Dermatology Consulting Services
    High Point, North Carolina 27262, United States
09

References and documents

Study documents

  • Protocol and statistical analysis plan · Jan 29, 2024

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 9, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT06357221
Lead sponsor
Galderma R&D
Responsible party
Sponsor
First posted
Apr 10, 2024
Start date
Apr 8, 2024
Primary completion
Jul 18, 2024
Completion
Jul 18, 2024
Results posted
Jun 9, 2026
Last update
Jun 9, 2026

Study contacts

Zoe D Draelos, MD
principal investigator · Dermatology Consulting Services, High Point NC
George F Hougeir, MD
principal investigator · Southeast Dermatology Specialist, LLC

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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