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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Skincare Product Treatment | Experimental | Subjects will use topical skincare products to assigned side of the body, per randomization. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cetaphil | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline, Week 2, Week 4, Week 8 |
| 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. | Baseline, Week 2, Week 4, Week 8 |
| 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. | Baseline, Week 2, Week 4, Week 8 |
| 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). | Baseline, Week 2, Week 4, Week 8 |
| 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Zoe D Draelos, MD | Dermatology Consulting Services, High Point NC | Principal Investigator |
| George F Hougeir, MD | Southeast Dermatology Specialist, LLC | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Southeast Dermatology Specialists, LLC | Columbus | Georgia | 31904 | United States | ||
| Southeast Dermatology Specialists, LLC |
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46 subjects met the inclusion and exclusion criteria, and were enrolled in the study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Skincare Product Treatment | Subjects applied the study products to the area of active lesion twice daily. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Skincare Product Treatment | Subjects applied study products to the area of active lesions twice daily. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Intention to treat population was used for primary outcome. | Posted | Mean | Standard Deviation | BSA % | Baseline, Week 2, Week 4, Week 8 |
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8 weeks (i.e., from the study start to the study completion).
Throughout the course of the study, all adverse events were monitored and reported on an adverse event CRF/eCRF without omitting any requested and known information.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Skincare Product Treatment | Subjects applied the study products to the area of active lesions twice daily. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Itchy | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Thu Q. Nguyen, PhD | Galderma | 8179615495 | thu.nguyen@galderma.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 29, 2024 | Apr 20, 2026 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D011565 | Psoriasis |
| ID | Term |
|---|---|
| D017444 | Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| C011189 | cetyl alcohol, propylene glycol, sodium lauryl sulfate non-lipid cleansing lotion |
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| Baseline, Week 2, Week 4, Week 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 as appropriate. Number of participants with favorable responses was provided for each question. | Week 2 |
| 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. | Week 4 |
| 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. | Week 8 |
| 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. | Baseline, Week 2, Week 4, Week 8 |
| 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. | Baseline, Week 2, Week 4, Week 8 |
| 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. | Baseline, Week 2, Week 4, Week 8 |
| Baseline, Week 8 |
| Douglasville |
| Georgia |
| 30135 |
| United States |
| Dermatology Consulting Services | High Point | North Carolina | 27262 | United States |
| Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | Participants |
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| Primary | 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. | Intention to treat population is used for primary outcome. | Posted | Mean | Standard Deviation | Score on a scale | Baseline, Week 2, Week 4, Week 8 |
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| Primary | 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. | Intention to treat population was used for primary outcome. | Posted | Mean | Standard Deviation | Score on a scale | Baseline, Week 2, Week 4, Week 8 |
|
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| Primary | 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). | This outcome measure was only performed at one study site only; therefore, the number of participants was representative of the selected study site and less than the total study participant number. Intention to treat population was used for primary outcome. | Posted | Mean | Standard Deviation | Pixels | Baseline, Week 2, Week 4, Week 8 |
|
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| Primary | 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). | This outcome measure was only performed at one study site only; therefore, the number of participants was representative of the selected study site and less than the total study participant number. Intention to treat population was used for primary outcome. | Posted | Mean | Standard Deviation | Pixels | Baseline, Week 2, Week 4, Week 8 |
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| Primary | 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. | Posted | Number | Participants with favorable responses | No | Week 2 |
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| Secondary | 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. | Intention to treat population was used for secondary outcome. | Posted | Mean | Standard Deviation | Score on a scale | Baseline, Week 8 |
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| Primary | 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. | Posted | Number | Participants with favorable responses | No | Week 4 |
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| Primary | 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. | Posted | Number | Participants with favorable responses | No | Week 8 |
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| Primary | 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. | Intention to treat population was used for primary outcome. | Posted | Mean | Standard Deviation | Score on a scale | Baseline, Week 2, Week 4, Week 8 |
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| Primary | 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. | Intention to treat population was used for primary outcome. | Posted | Mean | Standard Deviation | Score on a scale | Baseline, Week 2, Week 4, Week 8 |
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| Primary | 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. | Intention to treat population was used for primary outcome. | Posted | Mean | Standard Deviation | Score on a scale | Baseline, Week 2, Week 4, Week 8 |
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| 0 |
| 46 |
| 0 |
| 46 |
| 4 |
| 46 |
| Burning/Stinging | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Subjects reported their skin felt nourished after using the regimen |
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| Subjects reported it was easy to incorporate this skincare regimen into daily prescription routine |
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| Subjects reported this moisturizer had helped the lesions feel softer |
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| Subjects reported the skin lesions felt smoother since starting this moisturizer |
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| Subjects reported their skin looked healthier since starting this moisturizer |
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| Subjects reported the moisturizer kept their skin feeling hydrated throughout the day |
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| Subjects reported this moisturizer helped smooth out their skin's rough texture |
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| Subjects reported their skin appeared healthier-looking since starting this moisturizer |
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| Subjects reported the skin lesions felt much softer since starting this moisturizer |
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| Subjects reported this moisturizer had helped the lesions feel more hydrated |
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| Subjects reported the skin lesions looked less flaky since starting this moisturizer |
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| Subjects reported this was thei favorite skincare regimen |
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| Subjects reported this skincare regimen was the perfect choice as part of prescription regimen |
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| Subjects reported their skin was at the healthiest-looking state since using this moisturizer |
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| Subjects reported this moisturizer helped sooth my sensitive skin |
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| Subjects reported they loved how soft their skin felt |
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| Subjects reported the skin lesions had been consistently hydrated since using this moisturizer |
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| Subjects reported this moisturizer helped smoothen out the rough, scaly lesions |
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