ISRCTN ISRCTN15774173
DOI https://doi.org/10.1186/ISRCTN15774173
Integrated Research Application System (IRAS) 329123
Central Portfolio Management System (CPMS) 58276
Sponsor protocol number 22DE002
Sponsor Nottingham University Hospitals NHS Trust
Funder National Institute for Health and Care Research
Submission date
12/05/2026
Registration date
13/05/2026
Last edited
13/05/2026
Recruitment status
Not yet recruiting
Overall study status
Ongoing
Condition category
Skin and Connective Tissue Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

Background and study aims
This study is part of the Rapid Eczema Trials project (Eczema Bathing Study: https://www.isrctn.com/ISRCTN12016473, and
Keep Control of Eczema Study: https://www.isrctn.com/ISRCTN29214215). These studies hope to answer many questions about how to look after eczema. People with eczema are helping to design and run these studies. This means that the project will answer important questions for people with eczema.

Itch is a common symptom of eczema, and scratching is a response to feeling itchy. Over time, the response of scratching can form a habit, where people scratch even if they don’t feel itchy. Scratching can also lead to worsening of the itch and make the eczema worse. There are various ways of helping people to reduce how much they scratch in the hope of breaking this itch-scratch cycle. One of these approaches – the Scratch Less programme is being tested in this study.

Who can participate?
People aged 8 years or older who have eczema and would like to reduce their scratching can join the study. The researchers are encouraging people from all different backgrounds to take part.

What does the study involve?
People will join the study by signing up on the study website. They will answer questions about their eczema and how they currently treat it. They will then be put into one of two groups at random. One group will be asked to follow the Scratch Less 3-part online programme. The other group will be asked to follow their usual care for their eczema.

The Scratch Less programme starts by helping people to treat their eczema, and then supports people to try to reduce their scratching behaviour. This involves becoming more aware of the scratching, identifying the situations and reasons scratching is occurring, and then replacing the scratching with doing something else instead. The Scratch Less programme can be done at people’s own pace, but is designed to be completed over 3 weeks.

Everyone will be in the study for 4 months. They will be asked to complete some questions, sent to them by email/text message, each month. People will receive reminders to complete the questionnaires by email/text message/telephone call, and information may be collected over the phone if needed. People can take part from home and do not need to travel.

It is not yet known if the Scratch Less programme works, but people in the usual care group will be able to try it at the end of the study if they would like to.

Soon after the study results are known, they will be shared on the study website (https://rapideczematrials.org/).

What are the possible benefits and risks of participating?
It is hoped that this study will help people to understand how best to manage their eczema. Some people like to feel they are helping others by taking part, and some people like to try new things out for themselves.

The researchers do not think people are likely to come to any harm in this study. People can use their eczema creams and treatments to help improve their symptoms and should speak to their usual healthcare professionals if needed.

Where is the study run from?
The study is being organised by Nottingham University Hospitals NHS Trust (the Sponsor) and is coordinated by the University of Nottingham. Participants join the study online and take part from home, so they can live anywhere within the UK.

When is the study starting and how long is it expected to run for?
May 2026 to August 2027

Who is funding the study?
National Institute for Health and Care Research (NIHR), UK.

Who is the main contact?
RapidEczemaTrials@nottingham.ac.uk

Contact information

Mrs Eleanor Harrison
Public

Nottingham Clinical Trials Unit
University of Nottingham
Applied Health Research Building
University Park
Nottingham
NG7 2RD
United Kingdom

ORCiD logoORCID ID 0000-0003-0652-3980
Phone +44 (0)115 8231600
Email rapideczematrials@nottingham.ac.uk
Prof Kim Thomas
Principal investigator, Scientific

Centre of Evidence Based Dermatology
School of Medicine
University of Nottingham
Applied Health Research Building
University Park
Nottingham
NG7 2RD
United Kingdom

ORCiD logoORCID ID 0000-0001-7785-7465
Phone +44 (0)115 84 68632
Email kim.thomas@nottingham.ac.uk
Dr Laura Howells
Scientific

Centre of Evidence Based Dermatology
School of Medicine
University of Nottingham
Applied Health Research Building
University Park
Nottingham
NG7 2RD
United Kingdom

ORCiD logoORCID ID 0000-0003-4157-7394
Phone +44 (0) 115 84 68631
Email Laura.Howells1@nottingham.ac.uk

Study information

Primary study designInterventional
AllocationRandomized controlled trial
MaskingOpen (masking not used)
ControlActive
AssignmentParallel
PurposePrevention, Supportive care
Scientific titleImpact of an online intervention to address the itch-scratch cycle on eczema symptoms, quality of life, disease control and patient enablement in children and adults with eczema: two online, superiority, randomised controlled trials
Study acronymScratch Less Study
Study objectives AIM: To assess the impact of a 3-part online intervention on eczema symptoms compared with usual care over a period of 16 weeks in children and adults with eczema.

OBJECTIVES:
1. To assess the impact on eczema symptoms of an online intervention addressing the itch-scratch cycle compared with usual care alone in two populations:
1.1. Children aged 8-12 years
1.2. Adults and young people (aged 13 years and over)

2. To explore barriers and facilitators in using the online intervention and inform routes to implementation.

This study is part of the Rapid Eczema Trials project, which aims to answer many questions about how to manage eczema through the delivery of multiple online clinical trials (https://rapideczematrials.org/). An "Eczema Research Community" of people with eczema is helping to prioritise, design and run these studies. This means that the project will answer important questions for people with eczema.
Ethics approval(s)

Approved 27/04/2026, London - Surrey Research Ethics Committee (2 Redman Place, Stratford, London, E20 1JQ, United Kingdom; +44 (0)207 1048088; surrey.rec@hra.nhs.uk), ref: 23/PR/0899

Health condition(s) or problem(s) studiedEczema in people aged 8 years and older
InterventionINTERVENTION: A 3-part online programme to support management of itch and scratch for people with eczema plus usual care.

CONTROL: Usual eczema care alone.

The intervention is adapted from the ‘Kids in Control’ intervention developed by Dr Susannah Baron and team at King’s College London (https://ppopderm.org/project/kids-in-control/). Kids in Control uses a combined approach that educates on how to use eczema treatments alongside habit reversal techniques from behavioural psychology (raising awareness of scratching behaviour and replacing the behaviour). The Kids in Control intervention was designed to be delivered by a healthcare professional in an online group setting for 8-12-year-olds. Therefore, to make it suitable for evaluation in this study, we have adapted the intervention (with user testing through think-aloud interviews) to make it suitable for stand-alone self-directed online use and to create a version suitable for older children and adults aged 13+ years.

The online programme is divided into 3 parts. It is self-directed, but it is suggested that each part is completed a week apart, with activities completed between sessions to put the learning into practice:

Part 1: Individuals learn more about eczema and how to use the two main topical treatments for eczema (emollients and topical corticosteroids).

Part 2: Individuals learn about the itch-scratch cycle in eczema and how to become aware of their scratching. They are encouraged to use a scratching diary to track their scratching.

Part 3: Individuals learn a series of new activities they can try out to replace their scratching behaviour. They are encouraged to keep tracking their progress.

Randomisation will be carried out by the participant using a secure, online system. Participants will be randomised 1:1 to either the intervention group (Scratch Less programme) or control group (usual care alone) separately for the two age groups (8-12 years and 13 years and over) using a minimisation algorithm with a probabilistic element balancing on the following factors:
• Eczema severity POEM score (0-7 mild, 8-16 moderate, 17-28 severe)
• Age (13+ years group only: 13 to 15, 16 to 25, 26 to 55, > 55 years)
• Gender (male, female, other)
• Use of systemic treatments or super potent topical corticosteroids (no, yes started less than 3 months ago, yes started 3 months ago or more)

Following randomisation, participants in the intervention group will be provided with access to the online programme via an individual user account that will be created for them. Children aged 8-12 years will receive access to the ‘child version’ and use the intervention with parent/carer support. Participants aged 13 years or over will receive access to the 13+ version and use the intervention independently (unless help is required on an individual basis).

All participants can use their usual eczema treatments (e.g. emollients and flare control creams) and will remain under the care of their usual healthcare professional during the trial.

This is a decentralised clinical trial with screening, e-Consent, data collection and randomisation all taking place online.
Intervention typeBehavioural
Primary outcome measure(s)
  1. Eczema symptoms measured using the Patient Oriented Eczema Measure (POEM) (7 items scored 0 to 28) at baseline and every 4 weeks over 16 weeks
Key secondary outcome measure(s)
  1. Eczema control measured using the Recap of Atopic Eczema (RECAP) (7 items, scored 0 to 28) at baseline, week 4 and week 16
  2. Itch intensity measured using the Peak Pruritis Numerical Rating Scale (NRS) (one item, scored 0 to 10) at baseline and every 4 weeks over 16 weeks
  3. Scratching over the last week measured using a questionnaire at baseline, week 4 and week 16
  4. Skin-specific quality of life measured using the Children’s Dermatology Life Quality Index (CDLQI) or Dermatology Life Quality Index (DLQI) (10 items, scored 0 to 30) at baseline and week 16
  5. Patient enablement measured using the Patient Enablement Instrument (PEI) at baseline and week 16
  6. Adverse events: measured using a questionnaire which collects: a) Contact with healthcare professional (HCP) because of a worsening of the eczema; b) Open question to capture unexpected events, at week 16
  7. Frequency of skin bleeding due to eczema measured using the Patient Oriented Eczema Measure (POEM) (item 3) at baseline and every 4 weeks over 16 weeks
  8. Proportion of participants who achieve an improvement in POEM of ≥3 points measured using the Patient Oriented Eczema Measure (POEM) at baseline and week 16
Completion date31/08/2027

Eligibility

Participant type(s)
Age groupMixed
Lower age limit8 Years
Upper age limit120 Years
SexAll
Target sample size at registration556
Key inclusion criteria1. Aged ≥8 years with self-report of eczema (syn. atopic dermatitis, atopic eczema)
2. Able and willing to participate in the online intervention
3. Usual residence in the UK
4. Able and willing to give informed consent (or parent/legal guardian able and willing to give informed consent for children under 16 years)
Key exclusion criteria1. Diagnosis unlikely to be atopic eczema: only present on hands (likely to be hand eczema or contact dermatitis); limited to locations where skin is exposed to nickel, e.g. jewellery (likely to be contact dermatitis); eczema only around varicose veins (likely to be varicose eczema)
2. Taking part in another eczema intervention trial
3. Member of household has already agreed to take part in the Scratch Less trial
Date of first enrolment14/05/2026
Date of final enrolment30/04/2027

Locations

Countries of recruitment

  • United Kingdom
  • England

Study participating centre

All recruitment will take place online via the Rapid Eczema Trials website
https://rapideczematrials.org
Nottingham
NG7 2RD
England

Results and Publications

Individual participant data (IPD) Intention to shareYes
IPD sharing planThe datasets generated during and/or analysed during the current study will be available upon request from Nottingham Clinical Trials Unit (NCTU) (ctu@nottingham.ac.uk) in accordance with NCTU's data sharing procedure.

Access to the data will be subject to review of a data sharing and use request by a committee, including the CI and sponsor and will only be granted upon receipt of a data sharing and use agreement.

Any data shared will be de-identified.

Consent from participants to share data was obtained.

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Protocol file version 5.0 18/03/2026 13/05/2026 No No

Additional files

49525_Rapid Eczema Trials master protocol_v5.0_18Mar2026.pdf
Protocol file

Editorial Notes

13/05/2026: Study's existence confirmed by Health Research Authority (HRA) (UK).