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

Last updated: October 22, 2024
Sponsor: Galderma R&D
Overall Status: Completed

Phase

4

Condition

Psoriasis And Psoriatic Disorders

Rash

Rosacea

Treatment

Cetaphil

Clinical Study ID

NCT06357221
GLI.04.US.SL.035
  • Ages > 18
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

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 AmericanIndian or Alaska Native, Eastern/Southeastern Asian, South Asians, Black or AfricanAmerican, Native Hawaiian or Other Pacific Islander.

  5. Any ethnicities, with effort to include minimum 10% (n = 4) of Hispanic, Latino, orSpanish 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) andcumulative Target Lesion Severity Score (TLSS) ≥ 6.

  8. Currently on or starting a plaque psoriasis prescription treatment such asbiologics, 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 durationof the study.

  11. Subject willing to replace current skincare products with study products for theduration 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 bewilling to take a urine pregnancy test (UPT) at Baseline visit. (Females ofnon-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 tothe site on the day(s) and at the time(s) scheduled for the assessments

Exclusion

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, personalcare 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, thatmight interfere with the diagnosis or evaluation of study parameters at thediscretion of the investigator.

  5. Planning on having surgeries and/or invasive medical procedures during the course ofthe study

  6. Treatment with chemotherapy, immunosuppressive agents, prescription corticosteroidsfor psoriasis, immunomodulatory therapy (e.g., monoclonal antibodies or antiviraltreatment for human immunodeficiency virus or hepatitis C)

  7. History or presence of any medical condition that, in the opinion of theInvestigator, 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'sopinion, (e.g., subjects failing baseline assessments, subjects not likely to avoidother treatments in the treated areas, subjects anticipated to be unavailable orincapable of understanding the study assessments or having unrealistic expectationsof 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 theSponsor company.

  10. Participation in any interventional clinical study within 30 days of screening orplanning to participate in another interventional clinical research study whileenrolled in this trial.

Study Design

Total Participants: 46
Treatment Group(s): 1
Primary Treatment: Cetaphil
Phase: 4
Study Start date:
April 08, 2024
Estimated Completion Date:
July 18, 2024

Study 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.

Connect with a study center

  • Southeast Dermatology Specialists, LLC

    Columbus, Georgia 31904
    United States

    Site Not Available

  • Southeast Dermatology Specialists, LLC

    Douglasville, Georgia 30135
    United States

    Site Not Available

  • Dermatology Consulting Services

    High Point, North Carolina 27262
    United States

    Site Not Available

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