Plaque Psoriasis, Psoriasis
Conditions
Brief 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.
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.
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.
Sponsors
Galderma R&D
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Psoriatic Body Surface Area Compared to Baseline | Baseline, Week 2, Week 4, Week 8 | 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. |
| Change in Target Lesion Severity Compared to Baseline | Baseline, Week 2, Week 4, Week 8 | 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. |
| Change of Physician Global Assessment Compared to Baseline | Baseline, Week 2, Week 4, Week 8 | 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. |
| Change in Skin Scaliness Measured by Macroscopic Imaging | Baseline, Week 2, Week 4, Week 8 | 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). |
| Change in Skin Smoothness Measured by Macroscopic Imaging | Baseline, Week 2, Week 4, Week 8 | 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). |
| Subject Treatment Satisfaction | Week 2 | 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. |
| Changes in Dryness Compared to Baseline [Tolerability Assessment] | Baseline, Week 2, Week 4, Week 8 | 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. |
| Change in Burning/Stinging Compared to Baseline [Tolerability Assessment] | Baseline, Week 2, Week 4, Week 8 | 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. |
| Change in Itching Compared to Baseline [Tolerability Assessment] | Baseline, Week 2, Week 4, Week 8 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Subject Quality of Life Satisfaction | Baseline, Week 8 | 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORZoe D Draelos, MD
Dermatology Consulting Services, High Point NC
PRINCIPAL_INVESTIGATORGeorge F Hougeir, MD
Southeast Dermatology Specialist, LLC
Participant flow
Pre-assignment details
46 subjects met the inclusion and exclusion criteria, and were enrolled in the study.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 57.2 Years STANDARD_DEVIATION 15.9 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 5 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 41 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 16 Participants |
| Race (NIH/OMB) More than one race | 5 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 24 Participants |
| Region of Enrollment United States | 46 Participants |
| Sex: Female, Male Female | 24 Participants |
| Sex: Female, Male Male | 22 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 46 |
| other Total, other adverse events | 4 / 46 |
| serious Total, serious adverse events | 0 / 46 |
Outcome results
None listed