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Long-term Treatment of Scalp Psoriasis With Xamiol® Gel in a Large Adult Chinese Population

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02533973
Recruitment Status : Completed
First Posted : August 27, 2015
Last Update Posted : December 20, 2018
Sponsor:
Collaborator:
Tigermed Consulting Co., Ltd
Information provided by (Responsible Party):
LEO Pharma

Brief Summary:
A phase 4 trial comparing the safety and efficacy of treatment with Xamiol® gel (calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate)) once daily (as required) with Daivonex® scalp solution (calcipotriol 50 mcg/g) twice daily (as required) in Chinese subjects with scalp psoriasis

Condition or disease Intervention/treatment Phase
Psoriasis Vulgaris Drug: Xamiol® gel Drug: Daivonex® scalp solution Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 951 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Study Start Date : September 2015
Actual Primary Completion Date : March 6, 2018
Actual Study Completion Date : March 6, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis

Arm Intervention/treatment
Active Comparator: Xamiol® gel
calcipotriol 50mcg/g plus betamethasone 0.5 mg/g (as diproprionate) once daily as required, for up to 28 weeks
Drug: Xamiol® gel
Active Comparator: . Daivonex® scalp solution
calcipotriol 50mcg/g twice daily as required, for up to 28 weeks
Drug: Daivonex® scalp solution



Primary Outcome Measures :
  1. safety of Xamiol® gel (adverse events) [ Time Frame: 28 Weeks ]
    To establish the safety of Xamiol® gel over a long period for up to 28 weeks of treatment in Chinese subjects. Incidence of adverse drug reactions of any type and Incidence of adverse events of concern associated with long-term corticosteroid use on the scalp.


Secondary Outcome Measures :
  1. Efficacy of Xamiol® gel ( percentage of visits in which subjects had "Treatment success" according to Investigator's Global Assessment) [ Time Frame: 28 Weeks ]
    To establish the efficacy of Xamiol® gel over a long period for up to 28 weeks of treatment in Chinese subjects. The percentage of visits in which subjects had "Treatment success" according to Investigator's Global Assessment of disease severity during the treatment. The percentage of visits in which subjects had "Treatment success" according to subject's global assessment of disease severity during the treatment.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Signed and dated informed consent has been obtained.
  2. Subjects of either gender 18 years of age or above.
  3. At visit 1, a clinical diagnosis of scalp psoriasis which is:

    • of an investigator's assessment of clinical signs of the scalp of at least ≥ 2 in one of the clinical signs, redness, thickness, and scaliness, and at least 1 in each of the other two clinical signs, and total score ≥ 4
    • of an extent of 10% or more of the total scalp area
    • of at least mild severity according the investigator's global assessment
  4. Clinical signs of psoriasis vulgaris on trunk and/or limbs, or subject earlier diagnosed with psoriasis vulgaris on trunk and/or limbs.
  5. Female of childbearing potential using a reliable method of contraception for at least 1 month before the trial start and during the course of the trial (e.g., oral contraceptive pill, intrauterine device, contraceptive patches, implantable contraception, condoms) or females of non-childbearing potential (i.e. postmenopausal (absence of menstrual bleeding for 2 years), hysterectomy, bilateral ovariectomy, or tubal section/ligation).

Exclusion Criteria:

  1. Current diagnosis of guttate, erythrodermic, exfoliative, or pustular psoriasis.
  2. Subjects with any of the following conditions present on the scalp area: viral lesions, fungal and bacterial skin infections, parasitic infections, skin manifestations in relation to syphilis or tuberculosis, rosacea, acne vulgaris, acne rosacea, atrophic skin, striae atrophicae, fragility of skin veins, ichthyosis, ulcers, and wounds.
  3. Systemic treatment with biological therapies, whether marketed or not, with a possible effect on psoriasis vulgaris within the following time periods prior to randomisation and during the trial:

    • etanercept (Yisaipu) - within 4 weeks prior to randomisation
    • infliximab (Remicade) - within 2 months prior to randomisation
    • other products: within 4 weeks/5 half-lives (whichever is longer) prior to randomisation
  4. Systemic treatment with all other therapies with a possible effect on psoriasis vulgaris (e.g., corticosteroids, retinoids, methotrexate, ciclosporin and other immunosuppressant's, TCM [(traditional Chinese Medicine)]) within 4 weeks prior to randomisation or during the trial.
  5. PUVA therapy within 4 weeks prior to randomisation or during the trial.
  6. UVB therapy within 2 weeks prior to randomisation or during the trial.
  7. Therapies within 2 weeks prior to randomisation and during the trial:

    • Topical treatment of body psoriasis with very potent (WHO group IV) corticosteroids
    • Topical treatment of face psoriasis with potent or very potent (WHO group III and IV) corticosteroids
    • Any topical treatment of the scalp (except for non-steroid medicated shampoos and emollients)
  8. Known or suspected renal insufficiency or hepatic disorders or severe heart disease.
  9. Clinical signs or symptoms of Cushing's disease or Addison's disease.
  10. Known or suspected hypersensitivity to component(s) of IMPs
  11. Current participation in any other interventional clinical trial
  12. Subjects who have received treatment with any non-marketed drug substance (i.e. an agent which has not yet been made available for clinical use following registration) within 4 weeks/5 half-lives (whichever is longer) prior to randomisation.
  13. Previously participated in a clinical trial within 4 weeks prior to randomisation.
  14. In the opinion of the (sub) investigator, the subject is unlikely to comply with the clinical trial protocol (e.g. due to alcoholism, drug addiction or psychotic state).
  15. Females who are pregnant, or of child-bearing potential and wish to become pregnant during the trial, or who are breast-feeding.
  16. Females of child-bearing potential with a positive urine pregnancy test at visit 1.

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): NCT02533973


Locations
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China, Zhejiang
The Second Affiliated hospital Zhejiang University School of Medicine
Hangzhou, Zhejiang, China, 310009
Sponsors and Collaborators
LEO Pharma
Tigermed Consulting Co., Ltd
Investigators
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Principal Investigator: Min Zheng, MD, PHD Second Affiliated Hospital, School of Medicine, Zhejiang University

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Responsible Party: LEO Pharma
ClinicalTrials.gov Identifier: NCT02533973    
Other Study ID Numbers: LP0076-1079
First Posted: August 27, 2015    Key Record Dates
Last Update Posted: December 20, 2018
Last Verified: November 2018
Additional relevant MeSH terms:
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Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
Calcipotriene
Dermatologic Agents