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.: PACTR201810815694251 Date of Approval: 24/10/2018
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title A Randomised Controlled Trial Comparing Topical Glycerol versus Narrow Band Ultraviolet Light B in Atopic Dermatitis: A Clinical and Bacteriological Evaluation
Official scientific title A Randomised Controlled Trial Comparing Topical Glycerol versus Narrow Band Ultraviolet Light B in Atopic Dermatitis: A Clinical and Bacteriological Evaluation
Brief summary describing the background and objectives of the trial Background: Atopic dermatitis (AD) is a chronic allergic disorder whose treatment is still a challenge. The staphylococcal skin load has been previously shown to aggravate AD. Narrow band ultraviolet B (NB-UVB) and glycerol in low concentration (20-40%) are established therapies for AD. Narrow band-UVB has been clinically proven to have antimicrobial actions and high concentration glycerol (85-100%) has been proven in vitro to have similar effects but hasn’t been clinically tested. Objectives: To evaluate the efficacy and tolerability of glycerol (85%) compared to NB-UVB in patients with atopic dermatitis, as assessed by clinical improvement and reduction of staphylococcal colonization of the skin.
Type of trial RCT
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 Treatment: Other
Anticipated trial start date 30/10/2018
Actual trial start date
Anticipated date of last follow up 30/01/2019
Actual Last follow-up date
Anticipated target sample size (number of participants) 30
Actual target sample size (number of participants)
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
Parallel: different groups receive different interventions at same time during study Randomised Permuted block randomization Sealed opaque envelopes Masking/blinding used Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Glycerol An extemporaneous preparation of 85% glycerol in water to be applied once daily to lesional skin. 4 weeks 85% concentration was selected as our main aim is to test the antimicrobial effect in vivo to confirm in vitro studies on its efficacy (Saegeman et al., 2007). It will be prepared according to pharmacist’s advice, by adding 175ml distilled water to 1000g 99.5% glycerine (El-Gomhouria For Trading Chemicals and Medical Appliances (GOMAC), Egypt) and mixing well without heating till homogeneity is achieved. No additives or preservatives will be added. The preparation will be dispensed in 100ml rations in inert containers. 15
Control Group Narrow band ultraviolet B 3 sessions weekly. Initial dosage will start at 70% of the minimal erythema dose and subsequent increments will be adjusted according to erythema response. 4 weeks including a total of 12 sessions. NB-UVB is used as a gold standard for comparison as it is an established treatment for AD (Eichenfield et al., 2014), that also has proven antimicrobial effects (Jekler et al., 1992; Yoshimura et al. 1996; Silva et al. 2006; Dotterud et al. 2008). It will be delivered 3 sessions weekly by a UV cabin (Waldmann GmbH, Germany) equipped with an integrated UV photometer, having 16 TL-01/ 100W fluorescent lamps producing NB-UVB with a peak emission at 311 nm. The lamps are calibrated every 3 months. Initial dosage will start at 70% of the minimal erythema dose and subsequent increments will be adjusted according to erythema response. In case of faint erythema, the dose will be fixed. In case of mild erythema, the dose will be decreased to the previous dose. In case of moderate erythema, the sessions will be halted till it resolves and then resumed at 50% of the previous dose. If the moderate erythema is localized, the patient will be instructed to cover it using a cloth during the following session, then gradually expose it for half the exposure time in ensuing sessions. All children will be closely monitored by their guardians beside the cabin. All patients will be instructed to cover their genitalia and eyes during the sessions using appropriate gear, as per phototherapy unit safety regulations. Patients who miss 1 or 2 sessions will be allowed to resume at their last dose and the skipped sessions will be recouped so that all patients complete 12 sessions in total. 15 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Patients with mild to moderate atopic dermatitis, defined according to Hanifin and Rajka criteria by the presence of 3 major and 3 minor criteria, and by scoring less than 50 points in SCORAD. Both genders. Age more than 6 years old, as children less than 6 are not allowed to be treated by whole cabinet NB-UVB as per phototherapy unit regulations. Severe AD: SCORAD>50 (Oranje, 2011). Erythrodermic patients and those indicated for more aggressive systemic immune suppressive therapy. Patients receiving systemic treatment within one month or topical treatment within 2 weeks before enrollment into the study. Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year,Child: 6 Year-12 Year,Middle Aged: 45 Year(s)-64 Year(s) 6 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 25/06/2018 Research Ethics Committee of Cairo University Faculty of Medicine
Ethics Committee Address
Street address City Postal code Country
1 Al-Saraya street, Manial, Cairo Cairo 11553 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Clinical effectiveness as assessed by reduction of SCORAD and/or of pruritus by at least 50%(SCORAD50 and ITCH50 respectively). 4 weeks
Primary Outcome Reduction of staphylococcal load on the skin of treated patients, as assessed quantitatively by log Colony Forming Units (CFU). 4 weeks
Primary Outcome Impact of staphylococcal colonization and initial severity on treatment response. 4 weeks
Secondary Outcome Prevention of flares or exacerbations that need topical or systemic therapy in the 4 week follow-up period after cessation of treatment. 8 weeks
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Kasr AlAiny Hospital 1 Al-Saraya Street, Manial Cairo 11553 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Self funded by investigator 1 Al-Saraya Street, Manial Cairo 11553 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Cairo University 1 Gamaa Street, Giza Cairo 12613 Egypt University
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Randa Youssef randayoussef@kasralainy.edu.eg 00201223712288 1 Al-Saraya Street, Manial
City Postal code Country Position/Affiliation
Cairo 11553 Egypt Professor of Dermatology Cairo University
Role Name Email Phone Street address
Public Enquiries Ahmed Mourad ahmedhm@gmail.com 00201112727687 1 Al-Saraya Street, Manial
City Postal code Country Position/Affiliation
Cairo 11553 Egypt Resident of dermatology Kasr AlAiny Hospital
Role Name Email Phone Street address
Scientific Enquiries Ahmed Mourad ahmedhm@gmail.com 00201112727687 1 Al-Saraya Street, Manial
City Postal code Country Position/Affiliation
Cairo 11553 Egypt Resident of dermatology Kasr AlAiny Hospital
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Undecided
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information