Can a study comparing the effectiveness of four different moisturisers used to treat children with eczema be done?

Choice Of Moisturiser in Eczema Treatment (COMET): A feasibility study of pragmatic, single blind, randomised clinical trial to compare the clinical and cost effectiveness of leave-on emollients in treatment of infant eczema in primary care - COMET

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2013-003001-26-GB

Enrollment

160

Registered

2013-12-20

Start date

2013-12-23

Completion date

Unknown

Last updated

2017-04-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Eczema MedDRA version: 16.1 Level: LLT Classification code 10003641 Term: Atopic eczema System Organ Class: 100000004858

Interventions

Trade Name: Diprobase Cream Product Name: Diprobase Cream Product Code: Not applicable Pharmaceutical Form: Cream Trade Name: Doublebase gel Product Name: Doublebase gel Product Code: Not applicable

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Children with doctor-diagnosed eczema (aged between 1 month and 3 years of age). Adult with parental responsibility available to give consent Are the trial subjects under 18? yes Number of subjects for this age range: 160 F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range 0 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range 0

Exclusion criteria

Exclusion criteria: Known sensitivity or allergy to any of study emollients or their constituents.

Design outcomes

Primary

Measure	Time frame
Primary end point(s): The primary outcome for this feasibility study is the proportion of children approached that were randomized to a study emollient and used it for the duration of the study. The likely primary outcome for the main trial, if funded, is the Eczema Area and Severity Index (EASI).;Main Objective: The principal research question for this feasibility study: Is it possible to recruit and retain participants from primary care into a four arm randomised control trial of emollients in children with eczema aged between 1 month and 3 years? The principal research question for the main trial: "Which is the most clinically and cost effective primary emollient to use in infants with eczema?";Secondary Objective: How do biophysical (corneometry - a quick, non-invasive means of measuring the water content of the skin), objective (EASI, SASSAD and TIS, which are structured ways of clinically assessing the skin) and POEM (a validated patient-reported outcome measure) measures of eczema severity compare? What are the minimal clinically important differences (MCID, the smallest change in an outcome that a patient would identify as important) for biophysical (corneometry) and objective (EASI, SASSAD and TIS) measures of eczema severity?;Timepoint(s) of evaluation of this end point: 3 months (84 days)	—

Measure

Time frame

Primary end point(s): The primary outcome for this feasibility study is the proportion of children approached that were randomized to a study emollient and used it for the duration of the study. The likely primary outcome for the main trial, if funded, is the Eczema Area and Severity Index (EASI).;Main Objective: The principal research question for this feasibility study: Is it possible to recruit and retain participants from primary care into a four arm randomised control trial of emollients in children with eczema aged between 1 month and 3 years? The principal research question for the main trial: "Which is the most clinically and cost effective primary emollient to use in infants with eczema?";Secondary Objective: How do biophysical (corneometry - a quick, non-invasive means of measuring the water content of the skin), objective (EASI, SASSAD and TIS, which are structured ways of clinically assessing the skin) and POEM (a validated patient-reported outcome measure) measures of eczema severity compare? What are the minimal clinically important differences (MCID, the smallest change in an outcome that a patient would identify as important) for biophysical (corneometry) and objective (EASI, SASSAD and TIS) measures of eczema severity?;Timepoint(s) of evaluation of this end point: 3 months (84 days)

—

Secondary

Measure	Time frame
Secondary end point(s): • Three Item Severity (TIS) scale • Six Area, Six Sign Atopic Dermatitis (SASSAD) score • Skin hydration (corneometry) • Patient Oriented Eczema Measure (POEM);Timepoint(s) of evaluation of this end point: 1 month (28 days), 2 months (56 days) and 3 months (84 days)	—

Countries

United Kingdom

Contacts

Public ContactBirgit Whitman

University of Bristol

birgit.whitman@bristol.ac.uk01173317130

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Mar 17, 2026