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

• ClinicalTrials.gov Identifier: NCT01195831
• Recruitment Status: Completed
• First Posted: September 6, 2010
• Results First Posted: April 19, 2012
• Last Update Posted: April 14, 2015
• Sponsor: LEO Pharma
• Information provided by (Responsible Party): LEO Pharma

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Scalp Psoriasis	Drug: Xamiol® gel; Drug: Calcipotriol scalp solution	Phase 3

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 244 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Investigator)
• Primary Purpose: Treatment
• Official Title: Multicentre, Randomized, Investigator-Blinded, Parallel-group Study to Assess the Efficacy and Safety of Xamiol® Gel Compared to Calcipotriol Scalp Solution in Patients With Scalp Psoriasis.
• Study Start Date: September 2010
• Actual Primary Completion Date: March 2011
• Actual Study Completion Date: March 2011

Arms and Interventions

Arm	Intervention/treatment
Experimental: Xamiol® gel; Calcipotriol (as hydrate) 50mcg/g plus betamethasone 0.5mg/g (dipropionate)	Drug: Xamiol® gel; Once daily application
Active Comparator: Calcipotriol scalp solution; Calcipotriol (as hydrate) 50 mcg/ml	Drug: Calcipotriol scalp solution; Twice daily application

Outcome Measures

Primary Outcome Measures :

1. Patients With "Controlled Disease" in Terms of "Clear" or "Minimal" According to Investigator's Global Assessment of Disease Severity at Week 4. [ Time Frame: 4 weeks ]
   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.

Secondary Outcome Measures :

1. Patients With "Controlled Disease" in Terms of "Clear" or "Minimal" According to Investigator's Global Assessment of Disease Severity at Week 2 [ Time Frame: 2 weeks ]
   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 at week 2 were rated as having Controlled disease.
2. Patients With "Controlled Disease" in Terms of "Clear" or "Very Mild" According to Patient's Global Assessment of Disease Severity at Week 2. [ Time Frame: 2 weeks ]
   Patients made a global assessment of the disease severity by use of a 5-point scale (Clear, Very Mild, Mild, Moderate, Severe). Patients classifying their disease as Clear or Very Mild at week 2 were rated as having Controlled disease. This assessment was made prior to the investigator's assessments.
3. Patients With "Controlled Disease" in Term of "Clear" or "Very Mild" According to Patient's Global Assessment of Disease Severity at Week 4. [ Time Frame: 4 weeks ]
   Patients made a global assessment of the disease severity by use of a 5-point scale (Clear, Very Mild, Mild, Moderate, Severe). Patients classifying their disease as Clear or Very Mild at week 4 were rated as having Controlled disease. This assessment was made prior to the investigator's assessments.
4. Patients With Success (Total Sign Score ≤1) at Week 4 [ Time Frame: 4 weeks ]
   Investigators assessed scalp psoriasis lesions in terms of three clinical signs: redness, thickness and scaliness. For each clinical sign a single score, reflecting the average severity of all lesions on the scalp, was derived according to a 5-point scale ranging from 0 to 4 (0= best;4= worst). The sum of the three individual scores (redness, thickness and scaliness) constituted a Total Sign Score of the scalp ranging from 0 to 12 (0= best;12= worst). Patients with a Total sign score of 0 or 1 at week 4 achieved "Success".
5. For Each Clinical Sign (Redness, Thickness, Scaliness), the Percentage of Patients With Success (Clinical Score=0) at Week 4 [ Time Frame: 4 weeks ]
6. Patients With Success (Patient's Itching Score=None) at Week 4 [ Time Frame: 4 weeks ]
7. Evaluation of the Quality of Life [ Time Frame: Baseline to weeks 2 and 4 ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 65 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Known or suspected abnormality of the calcium homeostasis.

Known or suspected severe renal insufficiency or severe hepatic disorders, or severe heart disease.

Clinical signs or symptoms of Cushing's disease or Addison's disease.

Planned extensive exposure to sun (e.g. when working outdoors) during the study, which may affect scalp psoriasis.

Females who are pregnant, or of child-bearing potential and wish to become pregnant during the study, or who are breast-feeding.

Females of child-bearing potential with a positive serum or urine pregnancy test at SV2.

Any clinically significant abnormality following review of screening laboratory tests (blood and urine samples), physical examination or blood pressure/heart rate measurement performed at SV2.

Participation in any other interventional clinical trial within 4 weeks prior to randomisation.

Contacts and Locations

Locations

China

Bei Jing Hospital Affiliated Ministry of Health

Beijing, China

Peking Union Medical College Hospital

Beijing, China

Peking University First Hospital Affiliated to Peking University

Beijing, China

Southwest Hospital Affiliated to Third Military Medical University

Chongqing, China

Second Hospital Affiliated to Medical College of Zhe Jiang University

Hangzhou, China

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

Nanjing, China

Changhai Hospital Affiliated to Second Military Medical University

Shanghai, China

Huashan Hospital Affiliated to Fu Dan University

Shanghai, China

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

Xi'an, China

Sponsors and Collaborators

LEO Pharma

Investigators

• Principal Investigator: Jinhua Xu, Professor; China

More Information

• Responsible Party: LEO Pharma
• ClinicalTrials.gov Identifier: NCT01195831
• Other Study ID Numbers: MBL 0802 CN
• First Posted: September 6, 2010
• Results First Posted: April 19, 2012
• Last Update Posted: April 14, 2015
• Last Verified: March 2015

Additional relevant MeSH terms:

Psoriasis; Skin Diseases, Papulosquamous; Skin Diseases; Calcipotriene; Dermatologic Agents