Efficacy and Safety of LEO 90100 Foam in Japanese Subjects With Psoriasis Vulgaris

Last updated: February 21, 2025
Sponsor: LEO Pharma
Overall Status: Completed

Phase

3

Condition

Warts

Psoriasis And Psoriatic Disorders

Skin Wounds

Treatment

Dovobet® ointment

LEO 90100 foam

Clinical Study ID

NCT03806790
LP0053-1422
  • Ages > 20
  • All Genders

Study Summary

Comparison of the efficacy of LEO 90100 foam with Dovobet® ointment in the treatment of psoriasis in Japanese subjects.

Eligibility Criteria

Inclusion

Key Inclusion Criteria:

  1. Signed and dated informed consent obtained

  2. Japanese subjects

  3. Aged 20 years or above

  4. Clinical diagnosis of psoriasis vulgaris amenable to topical treatment of less thanor equal to 30% BSA (excluding psoriasis on the face/genitals/skin folds).

  5. A target psoriasis lesion of at least mild severity on the body of a minimum size of 10 cm2 and scoring at least 2 (mild) for each of the clinical signs). The lesionmust not be on the scalp, face, genitals or skin folds.

  6. Women of childbearing potential must have a negative pregnancy test at Day 1 andagree to use an adequate methods of birth control during the trial.

  7. Able to communicate with the (sub)investigator and understand and comply with therequirements of the trial.

Exclusion

Key Exclusion Criteria:

  1. Systemic use of biological treatments with a potential effect on psoriasis vulgariswithin the specified time periods prior to randomisation (depending on treatment)

  2. Systemic treatments with all therapies other than biological treatments with apotential effect on psoriasis vulgaris within 4 weeks prior to randomisation

  3. PUVA therapy, UVB therapy or UVA therapy on the full body or on the target lesionwithin 4 weeks prior to randomisation

  4. Topical treatment of psoriasis on the areas to be treated with trial medicationwithin 2 weeks prior to randomisation

  5. Topical treatment of psoriasis on the face, genitals or skin folds with vitamin D3analogues, potent corticosteroids or immunosuppressants within 2 weeks prior torandomisation

  6. Topical treatment of conditions other than psoriasis with vitamin D3 analogues,potent corticosteroids or immunosuppressants within 2 weeks prior to randomisation

  7. Initiation or changes of medication that may affect psoriasis vulgaris during thetrial

  8. Patients with certain disorders or symptoms present on the areas to be treated withtrial medication: viral lesions of the skin, infections, skin manifestations, orfragility of skin veins

  9. Other inflammatory skin diseases that may confound the evaluation of psoriasisvulgaris

  10. Erythrodermic, exfoliative or pustular psoriasis on the areas to be treated withtrial medication

  11. Planned excessive exposure of areas to be treated with trial medication to eithernatural or artificial sunlight during the trial.

  12. Disorders of calcium metabolism

  13. Severe renal insufficiency, severe hepatic disorders or severe heart disease

  14. Hypersensitivity to any components of the investigational medicinal products.

  15. Cushing's disease or Addison's disease

  16. Subjects who have received treatment with any non-marketed drug substance within the 4 weeks prior to randomisation, or longer if for certain biological treatments

  17. History of cancer within the last 5 years (except completely cured skin cancer)

  18. Current participation in any other interventional clinical trial

  19. Previously randomised in this trial

  20. Women who are pregnant, wishing to become pregnant or are breast-feeding

  21. Chronic alcohol or drug abuse within 12 months prior to screening, or any conditionassociated with poor compliance

  22. Employees of the trial site or any other individuals directly involved with theplanning or conduct of the trial, or immediate family members of such individuals

Study Design

Total Participants: 182
Treatment Group(s): 2
Primary Treatment: Dovobet® ointment
Phase: 3
Study Start date:
January 24, 2019
Estimated Completion Date:
June 10, 2019

Study Description

A phase 3, national, multi-centre, 4-week, prospective, randomised, controlled, parallel-group, open trial of LEO 90100 foam versus Dovobet® ointment (both treatments containing calcipotriol hydrate plus betamethasone dipropionate) in Japanese subjects with psoriasis vulgaris.

Connect with a study center

  • Leo Pharma Investigational Site

    Fukutsu, Fukuoka 811-3217
    Japan

    Site Not Available

  • Leo Pharma Investigational Site

    Obihiro, Hokkaido 080-0013
    Japan

    Site Not Available

  • Leo Pharma Investigational Site

    Sapporo, Hokkaido 006-0814
    Japan

    Site Not Available

  • Leo Pharma Investigational Site

    Nonoichi, Ishikawa 921-8801
    Japan

    Site Not Available

  • Leo Pharma Investigational Site

    Kawasaki, Kanagawa 213-0001
    Japan

    Site Not Available

  • Leo Pharma Investigational Site

    Yokohama, Kanagawa 220-6208
    Japan

    Site Not Available

  • Leo Pharma Investigational Site

    Sendai, Miyagi 981-3133
    Japan

    Site Not Available

  • Leo Pharma Investigational Site

    Saitama-shi, Saitama 330-0854
    Japan

    Site Not Available

  • Leo Pharma Investigational Site

    Chiyoda-ku, Tokyo 101-0021
    Japan

    Site Not Available

  • Leo Pharma Investigational Site

    Itabashi-ku, Tokyo 173-8605
    Japan

    Site Not Available

  • Leo Pharma Investigational Site

    Kita-ku, Tokyo 115-0045
    Japan

    Site Not Available

  • Leo Pharma Investigational Site

    Koto-Ku, Tokyo 136-0074
    Japan

    Site Not Available

  • Leo Pharma Investigational Site

    Minato-Ku, Tokyo 108-0014
    Japan

    Site Not Available

  • Leo Pharma Investigational Site

    Setagaya, Tokyo 158-0094
    Japan

    Site Not Available

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.