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.: PACTR202209711529835 Date of Approval: 16/09/2022
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title THE EFFICACY OF MOISTURIZERS IN RESTORING HYDRATION,SKIN pH, AND REDUCING TRANS-EPIDERMAL WATER LOSS(TEWL) IN PATIENTS WITH ATOPIC DERMATITIS
Official scientific title THE EFFICACY OF MOISTURIZERS IN RESTORING HYDRATION,SKIN pH, AND REDUCING TRANS-EPIDERMAL WATER LOSS(TEWL) IN PATIENTS WITH ATOPIC DERMATITIS
Brief summary describing the background and objectives of the trial Background: Atopic dermatitis (AD) is one of the common diseases seen at the dermatology clinic. A major complaint and clinical feature among AD patients is dryness of the skin and this has led to moisturisers being a major part of the treatment of AD. Studies of skin biophysical properties in AD patients reveal decreased hydration and increased trans epidermal water loss (TEWL). A variety of moisturisers are available, and they all claim to be effective at moisturising the skin in patients with AD. Studies documenting their proven efficacy have been carried out in temperate and non-tropical climates. The tropical climate in Nigeria differs considerably, with her hot and humid environment and temperature ranging between 25-40°C. There is a dearth of literature documenting the tolerability and effectiveness of moisturisers in this setting. Topicrem®, one of the moisturisers available for use in management of AD is a new product in the Nigerian market. The product is a fluid and non-oily emulsion with a high moisturizing and lipid-replenishing power that instantly penetrates the skin without feeling sticky, thereby conferring 24-hour hydration following daily use. It has been used and validated successfully in other climes; however, it is yet to be clinically tested in Nigeria. The aim of this study, therefore, is to compare the recovery of skin hydration and normalization of TEWL in AD patients by Topicrem®, with the use of a validated moisturising lotion. Aim: To assess the efficacy of two moisturisers in restoring hydration, skin pH and Trans Epidermal Water Loss (TEWL) of patients with Atopic Dermatitis.
Type of trial CCT
Acronym (If the trial has an acronym then please provide) EMTPHADerm Study
Disease(s) or condition(s) being studied Skin and Connective Tissue Diseases
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Supportive care
Anticipated trial start date 13/07/2022
Actual trial start date 01/08/2022
Anticipated date of last follow up 31/12/2022
Actual Last follow-up date 31/03/2023
Anticipated target sample size (number of participants) 150
Actual target sample size (number of participants)
Recruitment status Recruiting
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 Non-randomised Sealed opaque envelopes Masking/blinding used Care giver/Provider
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group EMTPHADerm Study Topical cream application daily 3 months Base-line hydration, Skin-pH and trans epidermal water loss will be measured 75 Placebo
Experimental Group EMTPHADerm Study ONCE DAILY FOR 3 MONTHS 6 weeks and 3 MONTHS BASELINE HYDRATION, SKIN pH, TRAS-EPIDERMAL WATER LOSS MEASUREMENT 75
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
All consenting patients presenting with Atopic Dermatitis as defined by the UK Working Party criteria Pregnant women Patients with AD and other co-existing inflammatory dermatoses, such as Lichen Planus or Psoriasis Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 19 Year(s) 80 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 30/03/2022 Lagos University Teaching Hospital Health Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
ROOM 107, FIRST FLOOR, LUTH ADMINISTRATIVE BLOCK. Lagos 12003 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome minimise the trans-epidermal water loss TEWL and optimise the hydration status 3 MONTHS
Secondary Outcome frequent hospital visits, poor sleep of the patients and their carers, school and work absenteeism with attendant consequences, as well as draining of financial resources relates to reduced quality of life. 3 MONTHS
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Lagos University Teaching Hospital Dermatology Clinic. Lagos University Teaching Hospital Compound Lagos 12003 Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
UNIVERSITY OF LAGOS UNIVERSITY OF LAGOS , AKOKA, LAGOS 12003 Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor University of Lagos University of Lagos, Akoka, Lagos Lagos 12003 Nigeria University
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator ERERE OTROFANOWEI ererey@yahoo.co.uk +2348033263378 Department of Medicine, College of Medicine, University of Lagos
City Postal code Country Position/Affiliation
Lagos 12003 Nigeria Senior Lecturer
Role Name Email Phone Street address
Scientific Enquiries AYESHA AKINKUGBE aakinkugbe@unilag.edu.ng +2348023120993 Department of Medicine, College of Medicine, University of Lagos
City Postal code Country Position/Affiliation
Lagos 12003 Nigeria Senior Lecturer
Role Name Email Phone Street address
Public Enquiries OLUSOLA AYANLOWO oayanlowo@unilag.edu.ng +2348033263378 Department of Medicine, College of Medicine, University of Lagos
City Postal code Country Position/Affiliation
Lagos 12003 Nigeria Associate Professor
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Data obtained through this study may be provided to qualified researchers with academic interest in trans-epidermal water loss. Data or samples shared will be coded, with no PHI included. Approval of the request and execution of all applicable agreements (i.e. a material transfer agreement) are prerequisites to the sharing of data with the requesting party. Informed Consent Form,Statistical Analysis Plan,Study Protocol Data requests can be submitted starting 10 months after article publication and the data will be made accessible for up to 24 months. Extensions will be considered on a case-by-case basis. Access to trial IPD can be requested by qualified researchers engaging in independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA)
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