Condition category
Skin and Connective Tissue Diseases
Date applied
27/06/2017
Date assigned
19/07/2017
Last edited
17/07/2017
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Emollients are moisturisers that are applied directly to the skin to reduce water loss and cover it with a protective film. They are the recommended first treatment for patients with dry skin and eczema in children under 12. A number of studies have shown emollients, in particular colloidal emollients, to be safe and effective for the treatment of dry skin and inflammatory skin conditions such as eczema. However, it is suspected that adherence with this recommendation is generally poor. This can be for a number of reasons, including emollients not being offered or prescribed, failure to prescribe adequate quantities and patients not using them as frequently as necessary for optimal benefit. There is limited evidence on the impact of the use of emollients in terms of cost avoidance and reduction in the use of topical corticosteroids (TCS). Topical corticosteroids are most commonly prescribed for eczema topically (applied directly to the skin). They have many functions but among other things they are very effective at temporarily controlling inflammation. Very strong or potent TCS should not be used for prolonged periods of time over large areas of eczematous skin, due to concerns about potential side effects. Whereas most TCS are not expensive, some TCS can be relatively costly. The aim of this study is to examine prescribing patterns in the UK and outcomes based on those prescriptions. In addition, the study looks at whether patients treated with emollients as their first treatment had similar or lower needs for TCS and/or antibiotics.

Who can participate?
Patients with dry skin and/or eczema

What does the study involve?
The patients’ use of healthcare is analysed, including frequency of GP visits, prescriptions for dry skin and eczema, and the percentage of patients treated with TCS, antimicrobials and antibiotics. The costs to the NHS (cost of visits and medication) are also calculated.

What are the possible benefits and risks of participating?
The results of this study will be used to further assess the effectiveness and cost-effectiveness of emollients. This is a database analysis with no involvement from the patient’s perspective so there are no risks or benefits of participating in the study.

Where is the study run from?
Johnson & Johnson Consumer Ltd (UK)

When is the study starting and how long is it expected to run for?
January 2007 to December 2014

Who is funding the study?
Johnson and Johnson

Who is the main contact?
Dr Gill Nelson

Trial website

Contact information

Type

Scientific

Primary contact

Dr Gill Nelson

ORCID ID

Contact details

Foundation Park
Roxborough Way
Maidenhead
SL6 3UG
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

16_198R

Study information

Scientific title

Eczema and dry skin – observational analysis of patients prescription patterns and healthcare utilization: a retrospective observational cohort study

Acronym

Study hypothesis

Prescribing emollients for patients with dry skin and/or eczema is associated with lower use of steroid-containing ointments and of antibiotics (versus non-prescribing of emollients as first line therapy), and lower overall cost of care. Differences in outcomes and costs between emollient brands or types exist.

Ethics approval

Independent Scientific Advisory Committee (ISAC) provided by Clinical Practice Research Datalink (CPRD), 12/01/2017, ref: 16_198R

Study design

Retrospective observational cohort study

Primary study design

Observational

Secondary study design

Cohort study

Trial setting

Other

Trial type

Treatment

Patient information sheet

No participant information sheet available as this is a database analysis

Condition

Dry skin and/or eczema

Intervention

All patients with dry skin and/or eczema in 2008 and 2012 will be identified. Of those, patients with at least 2 distinct emollient prescriptions within 6 months of index will be identified and included in the “Exposed” cohort. Patients with 2 healthcare exposures (visits or prescriptions) for dry skin and/or eczema in 6 months but no emollient prescriptions at any time will be included in the “Control” cohort. The observational period before the dry skin and/or eczema diagnosis will be assessed and only patients with continuous ≥ 12 months of medical history prior to diagnosis (“washout period”), and ≥ 24 months post dry skin and/or eczema diagnosis will be included. The index date will be the date of dry skin and/or eczema diagnosis in those patients with at least 12 months washout period (i.e., first diagnosis in at least 12 months – this constitutes the “clean” period).

The trialists analysed the costs to the NHS associated with skin-related prescriptions and utilisation of the primary care healthcare system over for 2 years following time of first diagnosis of dry skin and/or eczema. They investigated whether the act of prescribing emollients or a specific branded emollient would negatively impact the NHS budget. There was no follow-up period.

Outcomes were measured over 2 years, post-index date. Visits were estimated using the Personal Social Services Research Unit (PSSRU) Costs of Health and Social Care 2015. Prescription costs were estimated using publicly-available cost per drug for 2015. The net ingredient cost (NIC) was obtained for all prescriptions and linked to all prescriptions within CPRD. The total cost per prescription was obtained by taking into consideration the amounts prescribed multiplied by the NIC per Quantity, as reported in the public documents. The perspective of this analysis is strictly that of the NHS – no other societal or otherwise related costs than the estimated cost for visits as per PSSRU and prescription costs using the NIC information were included in the total cost of care.

Intervention type

Mixed

Phase

Drug names

Primary outcome measures

Measured using CPRD database over a two year period from initial diagnosis (post-index):
1. Health care utilisation:
1.1 Frequency of GP visits
1.2. Prescriptions for dry skin and eczema

Secondary outcome measures

Measured using CPRD database over a two year period from initial diagnosis (post-index):
1. Percentage of patients treated with potent or very potent topical corticosteroids
2. Percentage of patients treated with antimicrobials and/or antibiotics

Overall trial start date

01/01/2007

Overall trial end date

31/12/2014

Reason abandoned

Eligibility

Participant inclusion criteria

1. Patients with dry skin and/or eczema in 2008 and 2012
2. Exposed cohort: patients with at least 2 distinct emollient prescriptions within 6 months of index
3. Control cohort: patients with 2 healthcare exposures (visits or prescriptions) for dry skin and/or eczema in 6 months but no emollient prescriptions at any time
4. Continuous ≥ 12 months of medical history prior to diagnosis (washout period) and ≥ 24 months post dry skin and/or eczema diagnosis. The index date will be the date of dry skin and/or eczema diagnosis in those patients with at least 12 months washout period (i.e., first diagnosis in at least 12 months – this constitutes the “clean” period)

Participant type

Patient

Age group

All

Gender

Both

Target number of participants

1,570

Participant exclusion criteria

1. Patients with concurrent skin diseases that are typically treated with topical corticosteroids (TCS) such as bullous pemphigoid, lupus, lichen planus, granuloma annulare, lichen sclerosis, alopecia areata and vitiligo
2. Patients with low-quality records or non-continuous data coverage
3. A diagnosis of dry skin-eczema during the washout period (12 months period prior to index diagnosis)

Recruitment start date

01/01/2008

Recruitment end date

31/12/2012

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Johnson & Johnson Consumer Ltd
SL6 3UG

Sponsor information

Organisation

Johnson & Johnson Ltd

Sponsor details

Foundation Park
Roxborough Way
Maidenhead
SL6 3UG
United Kingdom

Sponsor type

Industry

Website

Funders

Funder type

Industry

Funder name

Johnson and Johnson

Alternative name(s)

Johnson & Johnson, JNJ

Funding Body Type

private sector organisation

Funding Body Subtype

corporate

Location

United States of America

Results and Publications

Publication and dissemination plan

The study will be conducted according to the International Committee of Medical Journal Editors (ICMJE) guidelines. For methodological issues, the STROBE checklist will be followed. This study is expected to inform cost-effectiveness analyses and will be published in a dermatology journal.

IPD sharing statement
The datasets generated during and/or analysed during the current study are/will be available upon request from Rachel Weinstein (rweinst1@its.jnj.com).

Intention to publish date

31/07/2017

Participant level data

Available on request

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes