Clinical trial NCT06357221: A Study to Assess Efficacy and Tolerability of Topical Skincare Products on Psoriasis Patients
Official title: A Multi-center, Open-label, In-use Study to Assess Efficacy and Tolerability of Topical Skincare Products on Psoriasis Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Plaque Psoriasis
Psoriasis
Lead sponsor: Galderma R&D
Sponsor class: INDUSTRY
First posted: 2024-04-10
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in psoriatic Body Surface Area compared to baseline
timeFrame: Baseline, Week 2, Week 4, Week 8
measure: Change in target lesion severity compared to baseline
timeFrame: Baseline, Week 2, Week 4, Week 8
measure: Change of Physician Global Assessment compared to baseline
timeFrame: Baseline, Week 2, Week 4, Week 8
measure: Change in skin quality measured by macroscopic imaging
timeFrame: Baseline, Week 2, Week 4, Week 8
measure: Subject treatment satisfaction
timeFrame: Week 2, Week 4, Week 8
measure: Incidence of psoratic irritation [tolerability assessment]
timeFrame: Baseline, Week 2, Week 4, Week 8
Secondary outcomes:
measure: Subject Quality of Life Satisfaction
timeFrame: Baseline, Week 8
Other outcomes:
Locations:
city: Columbus
country: United States
facility: Southeast Dermatology Specialists, LLC
state: Georgia
city: Douglasville
country: United States
facility: Southeast Dermatology Specialists, LLC
state: Georgia
city: High Point
country: United States
facility: Dermatology Consulting Services
state: North Carolina
Study officials:
affiliation: Dermatology Consulting Services, High Point NC
name: Zoe D Draelos, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Southeast Dermatology Specialist, LLC
name: George F Hougeir, MD
role: PRINCIPAL_INVESTIGATOR
References: