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

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

Study Overview

• Status: Completed
• Conditions: Psoriasis Vulgaris
• Intervention / Treatment: Drug: Xamiol® gel; Drug: Daivonex® scalp solution

• Study Type: Interventional
• Enrollment (Actual): 951
• Phase: Phase 4

Contacts and Locations

Study Locations

• China
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310009
      • The Second Affiliated Hospital Zhejiang University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
safety of Xamiol® gel (adverse events)	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.	28 Weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Efficacy of Xamiol® gel ( percentage of visits in which subjects had "Treatment success" according to Investigator's Global Assessment)	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.	28 Weeks

Collaborators and Investigators

• Sponsor: LEO Pharma
• Collaborators: Tigermed Consulting Co., Ltd
• Investigators: Principal Investigator: Min Zheng, MD, PHD, Second Affiliated Hospital, School of Medicine, Zhejiang University

Study record dates

Study Major Dates

• Study Start: September 1, 2015
• Primary Completion (Actual): March 6, 2018
• Study Completion (Actual): March 6, 2018

Study Registration Dates

• First Submitted: August 20, 2015
• First Submitted That Met QC Criteria: August 26, 2015
• First Posted (Estimate): August 27, 2015

Study Record Updates

• Last Update Posted (Actual): December 20, 2018
• Last Update Submitted That Met QC Criteria: December 19, 2018
• Last Verified: November 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Skin Diseases, Papulosquamous; Psoriasis; Dermatologic Agents; Calcipotriene
• Other Study ID Numbers: LP0076-1079