Body PSOriasis: Long-term Relapse CONTROL

Psoriasis Vulgaris Clinical Trial

— PSO-CONTROL  

Official title:

Body PSOriasis: Long-term Relapse Control in Patients With Psoriasis Vulgaris in Daily Clinical Practice of Russian Dermatologists.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03402828
• Other study ID #: NIS-PSORIASIS-1379
• Status: Completed
• Start date: June 11, 2018
• Est. completion date: May 15, 2020

Study information

• Verified date: December 2019
• Source: LEO Pharma
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This non-interventional study of real-life clinical practice strategies for long-term relapse control in patients with psoriasis vulgaris is planned to enroll 650 adult patients from 60-100 Russian dermatology sites and follow the patients for up to 52 weeks. The study will map actual strategies and focus on patients' and dermatologists' experience with the different topicals used, including unspecified products with and without active drugs.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 764
• Est. completion date: May 15, 2020
• Est. primary completion date: May 15, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients planned to receive topical treatment of any kind to prevent relapse of symptoms
• Written informed consent

Exclusion Criteria:

• Contraindications to selected treatment
• Ongoing systemic treatment of psoriasis with steroids, anti-inflammatory drugs or phototherapy

Related Conditions & MeSH terms

• Psoriasis
• Psoriasis Vulgaris

Intervention

Drug:
• Any topical drug treatment
Any treatment strategy used to prevent relapse of psoriasis symptoms

Locations

Country	Name	City	State
Russian Federation	The State Autonomous Foundation of Public Health "Republic Clinical Dermatovenereological Dispensary" of the Republic of Tatarstan	Kazan	Tatarstan

Sponsors (1)

Lead Sponsor	Collaborator
LEO Pharma

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time of relapse	Length of relapse free period after start of maintenance strategy	Up to 52 weeks
Secondary	Dermatology Life Quality Index	Standard QoL measure within dermatology	Up to 52 weeks
Secondary	PGA (physician's global assessment of symptoms)	5-point verbal rating scale	Up to 52 weeks
Secondary	PsGA (patient's global assessment of symptoms)	5-point verbal rating scale	Up to 52 weeks