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

Psoriasis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06357221
• Other study ID #: GLI.04.US.SL.035
• Status: Recruiting
• Phase: Phase 4
• Start date: April 8, 2024
• Est. completion date: July 31, 2024

Study information

• Verified date: March 2024
• Source: Galderma R&D
• Contact: Sindhu Garimella
• Phone: 2146909747
• Email: sindhu.garimella[@]galderma.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: July 31, 2024
• Est. primary completion date: July 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Plaque Psoriasis
• Psoriasis

Intervention

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.

Locations

Country	Name	City	State
United States	Southeast Dermatology Specialists, LLC	Columbus	Georgia
United States	Southeast Dermatology Specialists, LLC	Douglasville	Georgia
United States	Dermatology Consulting Services	High Point	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Galderma R&D

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in psoriatic Body Surface Area compared to baseline	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 indicates an improvement.	Baseline, Week 2, Week 4, Week 8
Primary	Change in target lesion severity compared to baseline	Target lesion severity will be measured by the Target Lesion Severity Score. Target Lesion Severity Score assesses 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 is calculated as cumulative total of all 3 parameters, which a maximum score of 24 (8 x 3). A decrease in scores indicates an improvement.	Baseline, Week 2, Week 4, Week 8
Primary	Change of Physician Global Assessment compared to baseline	Physician Global Assessment assesses 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 indicates an improvement.	Baseline, Week 2, Week 4, Week 8
Primary	Change in skin quality measured by macroscopic imaging	Macroscopic imaging will be performed using Visioscan® VC 20plus to take an image of the target lesion. The Visioscan software will be used to calculate the analyze the images for skin roughness (SEr, an increase in values indicates an improvement in roughness) and smoothness (SEsm, a decrease in values indicates an improvement in skin smoothness).	Baseline, Week 2, Week 4, Week 8
Primary	Subject treatment satisfaction	Subjects will be asked about their perception, satisfaction, and preference with each study treatment using a self-assessment questionnaire. Questionnaires will be tabulated; and the frequency and percentage of all response options will be 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) will be tabulated and reported as appropriate. Percentage of favorable and unfavorable responses will be provided for each question.	Week 2, Week 4, Week 8
Primary	Incidence of psoratic irritation [tolerability assessment]	Tolerability assessment will be performed by the Investigator (parameter: dryness) and by subjects (parameters: burning/stinging and itching) using a 4-point analog scale (with half-point scores used as necessary to better describe the clinical condition). Investigator and subjects will grade 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 indicates tolerability/safety of the treatment products.	Baseline, Week 2, Week 4, Week 8
Secondary	Subject Quality of Life Satisfaction	Subjects will be asked about their life quality by completing a Quality of Life questionnaire. Each response will be assigned a numerical score, and all scores will be summed to determine the Dermatology Quality of Life Index. A decrease in score totals from baseline to Week 8 indicates an improvement.	Baseline, Week 8