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

Information source: LEO Pharma
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Scalp Psoriasis

Intervention: Xamiol® gel (Drug); Calcipotriol scalp solution (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: LEO Pharma

Official(s) and/or principal investigator(s):
Jinhua Xu, Professor, Principal Investigator, Affiliation: China

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.

Clinical Details

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 design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

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

Secondary outcome:

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

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

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

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

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

Patients With Success (Patient's Itching Score=None) at Week 4

Evaluation of the Quality of Life

Eligibility

Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.

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.

Locations and Contacts

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

Additional Information

Clinical Trials at LEO Pharma

Starting date: September 2010
Last updated: March 25, 2015

Page last updated: August 20, 2015

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