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

NCT ID: NCT06357221

Last Updated: 2024-10-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 46 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-04-08
• Study Completion Date: 2024-07-18

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.

Conditions

Plaque Psoriasis; Psoriasis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Skincare Product Treatment

Subjects will use topical skincare products to assigned side of the body, per randomization.

Group Type: EXPERIMENTAL

Cetaphil

Intervention Type: 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.

Interventions

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.

Intervention Type: DRUG

Other Intervention Names

Topical Skincare Treatment

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Galderma R&D

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Zoe D Draelos, MD

Role: PRINCIPAL_INVESTIGATOR

Dermatology Consulting Services, High Point NC

George F Hougeir, MD

Role: PRINCIPAL_INVESTIGATOR

Southeast Dermatology Specialist, LLC

Locations

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

Countries

United States

Other Identifiers

GLI.04.US.SL.035

Identifier Type: -

Identifier Source: org_study_id