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Efficacy and Safety of Xamiol® Gel Compared to Calcipotriol Scalp Solution in Patients With Scalp Psoriasis | Clinical Trials | Clareo Health

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

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.

NCT01195831•LEO Pharma

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - 65 years

Sex

ALL

Healthy Volunteers

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,
+13 more criteria

Locations (9)

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

Key Dates

Start Date

September 1, 2010

Primary Completion Date

March 1, 2011

Completion Date

March 1, 2011

Last Updated

March 12, 2025

Enrollment

244

ACTUAL participants

Conditions

Scalp Psoriasis

Interventions

Xamiol® gel

DRUG

Calcipotriol scalp solution

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 12, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

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