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Trial record 52 of 272 for:    Betamethasone

LEO 80185 Gel (Calcipotriol Hydrate Plus Betamethasone Dipropionate) in Japanese Subjects With Psoriasis

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ClinicalTrials.gov Identifier: NCT02668692
Recruitment Status : Completed
First Posted : January 29, 2016
Last Update Posted : May 3, 2017
Sponsor:
Collaborator:
CMIC Co, Ltd. Japan
Information provided by (Responsible Party):
LEO Pharma

Brief Summary:
To compare the efficacy and safety of LEO 80185 gel with Dovobet® ointment in the treatment of psoriasis in Japanese subjects.

Condition or disease Intervention/treatment Phase
Psoriasis Vulgaris Drug: LEO 80185 gel Drug: Dovobet ® ointment Phase 3

Detailed Description:
A phase 3, national, multi-centre, 4-week, prospective, randomised, controlled, parallel-group, open trial of LEO 80185 gel versus Dovobet® ointment in Japanese subjects with psoriasis vulgaris.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 210 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Efficacy and Safety of LEO 80185 Gel (Calcipotriol Hydrate Plus Betamethasone Dipropionate) in Japanese Subjects With Psoriasis Vulgaris
Study Start Date : February 2016
Actual Primary Completion Date : June 2016
Actual Study Completion Date : June 2016


Arm Intervention/treatment
Experimental: LEO 80185 gel Drug: LEO 80185 gel
calcipotriol hydrate 52.2 µg/g [equivalent to 50.0 µg/g calcipotriol] plus betamethasone dipropionate 0.643 mg/g, applied once daily to psoriasis lesions

Active Comparator: Dovobet ® ointment Drug: Dovobet ® ointment
calcipotriol hydrate 52.2 µg/g [equivalent to 50.0 µg/g calcipotriol] plus betamethasone dipropionate 0.643 mg/g, applied once daily to psoriasis lesions




Primary Outcome Measures :
  1. 'overall improvement' for the target lesion on the scalp, defined as 'substantial resolution' of clinical signs and/or at least 'moderately improved' in the general change in the lesion [ Time Frame: end of week 4 ]
    'Substantial resolution' is defined as a clinical score for thickness and scaliness of 0 and a clinical score for redness of 1 or less in the severity of clinical signs of the lesion


Secondary Outcome Measures :
  1. 'overall improvement' for the target lesion on the non-scalp area, defined as 'substantial resolution' of clinical signs and/or at least 'moderately improved' in the general change in the lesion [ Time Frame: end of week 4 ]
    'Substantial resolution' is defined as a clinical score for thickness and scaliness of 0 and a clinical score for redness of 1 or less in the severity of clinical signs of the lesion.

  2. The change in the sum of the scores (total sign score) for the severity of the three clinical signs (thickness, scaliness, redness) from baseline for each target lesion. [ Time Frame: end of week 4 ]


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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 1. Informed consent has been obtained.
  • 2. Japanese subjects
  • 3. Aged 20 years or above
  • 4. Clinical diagnosis of psoriasis vulgaris amenable to topical treatment of less than or equal to 30% BSA
  • 5. A target psoriasis lesion on the scalp and on the non-scalp area of the body, each lesion of a minimum size of 10 cm2 and scoring at least 2 (mild) for each of the clinical signs (redness, thickness and scaliness).
  • 6. Females of childbearing potential must have a negative result for a urine pregnancy test at Day 1 (Visit 1) and must agree to use an adequate method of birth control.
  • 7. Able to communicate with the (sub)investigator and understand and comply with the requirements of the trial.

Exclusion Criteria:

  • 1. Systemic use of biological treatments with a potential effect on psoriasis vulgaris
  • 2. Systemic treatments with all therapies other than biological treatments with a potential effect on psoriasis vulgaris
  • 3. PUVA therapy, UVB therapy or UVA therapy
  • 4. Topical treatment of psoriasis on the areas to be treated with trial medication
  • 5. Topical treatment of psoriasis on the face, genitals or skin folds with vitamin D analogues, potent or very potent corticosteroids or immunosuppressants
  • 6. Topical treatment of conditions other than psoriasis with vitamin D analogues, potent or very potent corticosteroids or immunosuppressants
  • 7. Planned initiation of, or changes in, concomitant medication that may affect psoriasis vulgaris
  • 8. Patients with any of the following disorders (a) or symptoms (b) present on the areas to be treated with trial medication: (a) viral (e.g., herpes or varicella) lesions of the skin, fungal, spirochetal or bacterial skin infections, parasitic infections, skin manifestations in relation to syphilis or tuberculosis, rosacea, acne vulgaris, atrophic skin, striae atrophicae, ichthyosis, acne rosacea, ulcers, burns, frostbite, wounds, animal skin disease (scabies, crabs, lice, etc.) or (b) fragility of skin veins.
  • 9. Other inflammatory skin diseases that may confound the evaluation of psoriasis vulgaris.
  • 10. Erythrodermic, exfoliative or pustular psoriasis
  • 11. Planned excessive exposure of areas to be treated with trial medication to either natural or artificial sunlight
  • 12. Known or suspected disorders of calcium metabolism associated with hypercalcaemia, or albumin-corrected serum calcium above the reference range
  • 13. Known or suspected severe renal insufficiency, severe hepatic disorders or severe heart disease.
  • 14. Known or suspected hypersensitivity to any components of the investigational products.
  • 15. Clinical signs or symptoms of Cushing's disease or Addison's disease
  • 16. Treatment with any non-marketed drug substance
  • 17. Current participation in any other interventional clinical trial
  • 18. Previously randomised in this trial
  • 19. Females who are pregnant, wishing to become pregnant or are breast-feeding

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02668692


Locations
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Japan
Medical Corporation Bikyukai Kokubu Dermatology
Kitami-shi, Hokkaido, Japan, 090-0832
Sponsors and Collaborators
LEO Pharma
CMIC Co, Ltd. Japan
Investigators
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Principal Investigator: Hidemi Nakagawa, MD Department of Dermatology, Jikei University School of Medicine, Tokyo, Japan

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Responsible Party: LEO Pharma
ClinicalTrials.gov Identifier: NCT02668692     History of Changes
Other Study ID Numbers: LP0076-1128
First Posted: January 29, 2016    Key Record Dates
Last Update Posted: May 3, 2017
Last Verified: May 2017
Keywords provided by LEO Pharma:
LEO 80185 gel, calcipotriol, betamethasone
Additional relevant MeSH terms:
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Betamethasone
Betamethasone Valerate
Betamethasone-17,21-dipropionate
Betamethasone benzoate
Betamethasone sodium phosphate
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
Calcitriol
Calcipotriene
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Dermatologic Agents
Calcium-Regulating Hormones and Agents
Calcium Channel Agonists
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Vasoconstrictor Agents
Vitamins
Micronutrients
Nutrients
Growth Substances
Bone Density Conservation Agents