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

NCT02533973 | Completed Phase 4

• 1 other identifier: LP0076-1079
• Study Type: interventional
• Target: 951
• Locations: 1 country
• Sites: 1

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

Conditions

Psoriasis Vulgaris

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Efficacy of Xamiol® gel ( percentage of visits in which subjects had "Treatment success" according to Investigator's Global Assessment)

  28 Weeks

Study Arms (2)

Xamiol® gel

ACTIVE COMPARATOR

calcipotriol 50mcg/g plus betamethasone 0.5 mg/g (as diproprionate) once daily as required, for up to 28 weeks

Drug: Xamiol® gel

. Daivonex® scalp solution

ACTIVE COMPARATOR

calcipotriol 50mcg/g twice daily as required, for up to 28 weeks

Drug: Daivonex® scalp solution

Interventions

Xamiol® gel DRUG

Xamiol® gel

Daivonex® scalp solution DRUG

. Daivonex® scalp solution

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed and dated informed consent has been obtained.
• Subjects of either gender 18 years of age or above.
• 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
• Clinical signs of psoriasis vulgaris on trunk and/or limbs, or subject earlier diagnosed with psoriasis vulgaris on trunk and/or limbs.
• 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).

You may not qualify if:

• Current diagnosis of guttate, erythrodermic, exfoliative, or pustular psoriasis.
• 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.
• 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
• 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.
• PUVA therapy within 4 weeks prior to randomisation or during the trial.
• UVB therapy within 2 weeks prior to randomisation or during the trial.
• 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)
• Known or suspected renal insufficiency or hepatic disorders or severe heart disease.
• Clinical signs or symptoms of Cushing's disease or Addison's disease.

Sponsors & Collaborators

• LEO Pharma: lead
• Tigermed Consulting Co., Ltd: collaborator

Study Sites (1)

The Second Affiliated hospital Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310009, China

Location

Study Officials

• Min Zheng, MD, PHD

  Second Affiliated Hospital, School of Medicine, Zhejiang University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 20, 2015
• First Posted: August 27, 2015
• Study Start: September 1, 2015
• Primary Completion: March 6, 2018
• Study Completion: March 6, 2018
• Last Updated: February 24, 2025

Record last verified: 2018-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)