NCT06357221

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

A Multi-center, Open-label, In-use Study to Assess Efficacy and Tolerability of Topical Skincare Products on Psoriasis Patients

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 46 (actual)
• Sponsor: Galderma R&D · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Plaque Psoriasis
• Psoriasis

Interventions

Type	Name	Description
DRUG	Cetaphil	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.

Timeline

• Start date: 2024-04-08
• Primary completion: 2024-07-18
• Completion: 2024-07-18
• First posted: 2024-04-10
• Last updated: 2024-10-24

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study