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

Completed · Phase 4

Conditions studied: Plaque Psoriasis, Psoriasis

In brief

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.

Key facts

Study ID

NCT06357221

Run by

Galderma R&D

People needed

46

Starts

2024-04-08

Expected to finish

2024-07-18

Last updated by the study team

2026-06-09

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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
• 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

You may not qualify if…

• 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)
• 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.

Where it is running

• Southeast Dermatology Specialists, LLC — Columbus, Georgia, United States
• Southeast Dermatology Specialists, LLC — Douglasville, Georgia, United States
• Dermatology Consulting Services — High Point, North Carolina, United States

Full record on ClinicalTrials.gov

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