Efficacy and Safety of Xamiol® Gel Compared to Calcipotriol Scalp Solution in Patients With Scalp Psoriasis

NCT01195831 | Completed Phase 3 Results

• 1 other identifier: MBL 0802 CN
• Study Type: interventional
• Target: 244
• Locations: 1 country
• Sites: 9

Brief Summary

The purpose of this study is to compare the clinical efficacy of once daily treatment for 4 weeks with Xamiol® gel (calcipotriol plus betamethasone) with twice daily treatment for 4 weeks with Calcipotriol Scalp Solution in patients with scalp psoriasis.

Conditions

Scalp Psoriasis

Outcome Measures

Primary Outcomes (1)

• Patients With "Controlled Disease" in Terms of "Clear" or "Minimal" According to Investigator's Global Assessment of Disease Severity at Week 4.

  Investigators made a global assessment of the disease severity by use of a 6-point scale (Clear, Minimal, Mild, Moderate, Severe and Very Severe). Patients with disease severity classified as Clear or Minimal disease after the treatment period (week 4) were rated as having Controlled disease.

  4 weeks

Secondary Outcomes (7)

• Patients With "Controlled Disease" in Terms of "Clear" or "Minimal" According to Investigator's Global Assessment of Disease Severity at Week 2

  2 weeks

• Patients With "Controlled Disease" in Terms of "Clear" or "Very Mild" According to Patient's Global Assessment of Disease Severity at Week 2.

  2 weeks

• Patients With "Controlled Disease" in Term of "Clear" or "Very Mild" According to Patient's Global Assessment of Disease Severity at Week 4.

  4 weeks

• Patients With Success (Total Sign Score ≤1) at Week 4

  4 weeks

• For Each Clinical Sign (Redness, Thickness, Scaliness), the Percentage of Patients With Success (Clinical Score=0) at Week 4

  4 weeks

Study Arms (2)

Xamiol® gel

EXPERIMENTAL

Calcipotriol (as hydrate) 50mcg/g plus betamethasone 0.5mg/g (dipropionate)

Drug: Xamiol® gel

Calcipotriol scalp solution

ACTIVE COMPARATOR

Calcipotriol (as hydrate) 50 mcg/ml

Drug: Calcipotriol scalp solution

Interventions

Xamiol® gel DRUG

Once daily application

Xamiol® gel

Calcipotriol scalp solution DRUG

Twice daily application

Calcipotriol scalp solution

Eligibility Criteria

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

You may qualify if:

• Patients of either gender between 18 and 65 years of age.
• A clinical diagnosis of scalp psoriasis which is:
• of an investigator's assessment of clinical signs of the scalp 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 moderate severity according the investigator's global assessment.
• Clinical signs of psoriasis vulgaris on trunk and/or limbs, or earlier diagnosed with psoriasis vulgaris on trunk and/or limbs.
• The patient must provide signed and dated informed consent before any study related activity is carried out.

You may not qualify if:

• Current diagnosis of guttate, erythrodermic, exfoliative or pustular psoriasis.
• Patients 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 vilgaris, acne rosacea, atrophic skin, striae atrophicae, fragility of skin veins, ichthyosis, ulcers and wounds.
• Any other inflammatory skin diseases that may confound the evaluation of scalp psoriasis
• Systemic treatment with biological therapies (marketed or not marketed), with a possible effect on scalp psoriasis (e.g., alefacept, efalizumab, etanercept, infliximab) within 3 months prior to visit 1 and during the study.
• Systemic treatment with all other therapies than biologicals, with a possible effect on scalp psoriasis (e.g., corticosteroids, vitamin D analogues, retinoids, immunosuppressants) within 4 weeks prior to SV2 or during the study.
• PUVA therapy within 4 weeks prior to randomisation (visit 1) or during the study.
• UVB therapy wthin 2 weeks prior to randomisation (visit 1) or during the study.
• Therapies within 2 weeks prior to SV2 and during the study.
• Topical treatment of psoriasis on non scalp psoriasis lesions with potent or very potent (WHO group III-IV) corticosteroids,
• Topical treatment of Immunomodulator, e.g. Tacrolimus,
• Vitamin D analogues (e.g, calcipotriol, tacalcitol, calcitriol),
• Any topical treatment of the scalp (except for non-steroid medicated shampoos and emollients,
• Other types of psoriasis treatment, e.g. Chinese medicine, processed Chinese medicine, or hot spring, etc.
• Planned initiation of, or changes to concomitant medication that could affect scalp psoriasis (e.g., beta blockers, anti-malaria drugs, lithium) during the study.
• Known or suspected hypersensitivity to component(s) of the Investigational Products.

Sponsors & Collaborators

• LEO Pharma: lead

Study Sites (9)

Bei Jing Hospital Affiliated Ministry of Health

Beijing, China

Location

Peking Union Medical College Hospital

Beijing, China

Location

Peking University First Hospital Affiliated to Peking University

Beijing, China

Location

Southwest Hospital Affiliated to Third Military Medical University

Chongqing, China

Location

Second Hospital Affiliated to Medical College of Zhe Jiang University

Hangzhou, China

Location

Chinese Academy of Medical Sciences & Peking Union Medical College, Institute of Dermatology, Nanjing

Nanjing, China

Location

Changhai Hospital Affiliated to Second Military Medical University

Shanghai, China

Location

Huashan Hospital Affiliated to Fu Dan University

Shanghai, China

Location

Xi Jing Hospital Affiliated to Fourth Military Medical University Xi Jing Hospital

Xi'an, China

Location

Related Links

• Clinical Trials at LEO Pharma

Results Point of Contact

• Title: Malin Jaernkrants
• Organization: Leo Pharma

malin.jaernkrants@leo-pharma.com

+4544945888

Study Officials

• Jinhua Xu, Professor

  China

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 3, 2010
• First Posted: September 6, 2010
• Study Start: September 1, 2010
• Primary Completion: March 1, 2011
• Study Completion: March 1, 2011
• Last Updated: March 12, 2025
• Results First Posted: April 19, 2012

Record last verified: 2015-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (9)