Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202403515609366 Date of Approval: 05/03/2024
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Environmental risk factors for psoriasis and the effect of educational program on the severity of the disease
Official scientific title the relation between exposure to some environmental risk factors and chronic psoriasis
Brief summary describing the background and objectives of the trial Background: Psoriasis is an autoimmune, chronic, and inflammatory skin disorder. Several genetic and environmental factors were suggested to be implicated in its pathogenesis. Objectives: The main objectives of this study were to examine how exposure to selected environmental factors was associated with psoriasis and to explore the role of raising psoriatic patient awareness about possible environmental risk factors in the reduction of the severity of the disease.
Type of trial Non-Randomised
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Skin and Connective Tissue Diseases
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Education /Training
Anticipated trial start date 26/05/2020
Actual trial start date 20/07/2020
Anticipated date of last follow up 25/01/2021
Actual Last follow-up date 08/04/2021
Anticipated target sample size (number of participants) 30
Actual target sample size (number of participants) 30
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Single Group Non-randomised Allocation was determined by the holder of the sequence who is situated off site Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group psoriatic patients An educational program was performed for all cases in the study. The program was conducted for three months (one session per month). Each session lasted for 30-45 minutes. The intervention group members (30 patients) were divided into 3 groups, ten patients each. 3 month An educational program was performed for all cases in the study. The program was conducted for three months (one session per month). The educational methods included lectures and group discussions, as each lecture was followed by interactive discussions. The educational program consisted of information about the importance of decreasing exposure to environmental risk factors of psoriatic patients such as: stopping cigarette smoking or shisha smoking, decreasing exposure to ETS, reducing exposure to stress (physical, chemical, and psychological), reducing weight, wearing protective equipment during work, especially in agriculture, industry, trading and other jobs (such as sunglasses, hats, protective clothes and use sunblock), increase use of emollients especially during winter, decrease eating salty or spicy food, reduce exposure to trauma, importance of having lower crowding index, reduce exposure to high temperature, heavy metals, insecticide, fixing problems in drinking water and sewage system, trying to live away from garages, petroleum stations, public transport stops, auto repair shops, places for collecting and burning garbage, incinerators, landfill or at least reduce time spent near them. It also stressed the importance of adherence to treatment to improve the health condition. PASI scoring was measured before and after the educational program to assess the change in disease severity. 30
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
The inclusion criteria for cases were adult patients with a definitive clinical diagnosis of plaque psoriasis confirmed by a dermatologist and having chronic psoriasis for more than one year. Exclusion criteria were patients with any chronic systemic diseases affecting the metabolism (such as Hepatitis B, C, and Diabetes Mellitus). Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 60 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 29/10/2019 the Ethics Committee of the High Institute of Public Health Alexandria University
Ethics Committee Address
Street address City Postal code Country
175, El-Horeya street. Alexandria 21561. Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome psoriasis severity measured by The Psoriasis Area and Severity Index (PASI) 3 months after finishing educational program
Secondary Outcome improvement in psoriasis condition each month
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Alexandria University Azareta street, Alexandria, Alexandria Alexandria Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Mohamed Fakhry Hussein 175 El-Horeya street Alexandria Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Alexandria University 175 El-Horeya Street Alexandria Egypt University
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Mohamed Hussein hiph-mohamedfakhry@alexu.edu.eg +21271266332 175 El-Horeyaa street
City Postal code Country Position/Affiliation
Alexandria Egypt lecturer of public health high institute of public health
Role Name Email Phone Street address
Public Enquiries Yasmin Maamon yasminmaamon@gmail.com +21222596920 140 Smoha street
City Postal code Country Position/Affiliation
Alexandria Egypt fellow of Alexandria Main University Hospitals
Role Name Email Phone Street address
Scientific Enquiries Mohamed Hussein hiph-mohamedfakhry@alexu.edu.eg +21271266332 175 El-Horeya street
City Postal code Country Position/Affiliation
Alexandria Egypt lecturer of public health at high institute of public health
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Yes, IPD will be shared. Individual participant data will be available after de-identifying individual trial participant data (text, tables, figures, and appendices). A statistical analysis plan and analytic code will also be available. It will be immediately after publication for the researchers who wish to access the data to achieve the aims of the approved proposal. proposal should be directed to hiph-mohamedfakhry@alexu.edu.eg Study Protocol data will be available just after publication, with no end date all researchers who are interested in the study.
URL Results Available Results Summary Result Posting Date First Journal Publication Date
https://docs.google.com/document/d/1C80DNzeXczmdjGBDO4kHrpWJVsJQR9fs/edit?rtpof=true Yes 09/02/2024
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result - 09/02/2024
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information