Additional effect of topical coal tar in adults with atopic dermatitis.

A randomized controlled trial evaluating the additional effect of topical coal tar to a topical corticosteroid regimen in patients aged >16 years of age with moderate-severe atopic dermatitis.

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2016-004687-19-NL

Enrollment

Registered

2017-01-25

Start date

2018-04-23

Completion date

Unknown

Last updated

2021-10-08

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

Conditions

Atopic Dermatitis (AD) MedDRA version: 19.1 Level: LLT Classification code 10003639 Term: Atopic dermatitis System Organ Class: 100000004858

Interventions

Trade Name: Betnelan ointment (betamethason valerate 1mg/g ointment) Product Name: Betnelan ointment (betamethason valerate 1mg/g ointment) Pharmaceutical Form: Ointment Trade Name: Hydrocortison ace

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Male or female patients aged >16 years of age - Diagnosis of AD based on the criteria of Hanifin and Rajka - Moderate to severe AD based on EASI score >7.1 Are the trial subjects under 18? yes Number of subjects for this age range: 5 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 46 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 5

Exclusion criteria

Exclusion criteria: - Hypersensitivity and/or intolerance to topical corticosteroids or topical coal tar - Indication for systemic therapy or a medical need to use a higher level of topical corticosteroids than potent topical corticosteroids

Design outcomes

Primary

Measure	Time frame
Main Objective: To evaluate the additional effect of coal tar treatment to a corticosteroid regimen in adults (aged >16 years of age) with moderate to severe atopic dermatitis, based on the percentage change in Eczema Area and Severity Index (EASI) at week 2. ;Secondary Objective: Secondary outcomes: percentage change in EASI at week 4, the proportion of patients with EASI-75 at week 2 and week 4, decrease in NRS score for pruritus, changes in patient-reported outcome (POEM and Patient PGA), changes in quality of life (DLQI), and tolerability of both treatments. In addition, we aim to investigate a possible association between a filaggrin (FLG) genotype and efficacy of topical coal tar and/or topical corticosteroids, and to evaluate changes in Natural Moisturizing Factor (NMF) levels in the stratum corneum and the skin microbiota between patients treated with topical coal tar and/or topical corticosteroids.;Primary end point(s): The primary outcome is the percentage change in EASI score at week 2. ;Timepoint(s) of evaluation of this end point: Baseline, week 2, week 4	—

Measure

Time frame

Main Objective: To evaluate the additional effect of coal tar treatment to a corticosteroid regimen in adults (aged >16 years of age) with moderate to severe atopic dermatitis, based on the percentage change in Eczema Area and Severity Index (EASI) at week 2. ;Secondary Objective: Secondary outcomes: percentage change in EASI at week 4, the proportion of patients with EASI-75 at week 2 and week 4, decrease in NRS score for pruritus, changes in patient-reported outcome (POEM and Patient PGA), changes in quality of life (DLQI), and tolerability of both treatments. In addition, we aim to investigate a possible association between a filaggrin (FLG) genotype and efficacy of topical coal tar and/or topical corticosteroids, and to evaluate changes in Natural Moisturizing Factor (NMF) levels in the stratum corneum and the skin microbiota between patients treated with topical coal tar and/or topical corticosteroids.;Primary end point(s): The primary outcome is the percentage change in EASI score at week 2. ;Timepoint(s) of evaluation of this end point: Baseline, week 2, week 4

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Secondary

Measure	Time frame
Secondary end point(s): percentage change in EASI score at week 4, EASI-75 at week 2 and week 4, Pruritus NRS, Patient Oriented Eczema Measure (POEM), Patient Global Assessment of Disease Severity (PGA), Health-related Quality of Life (DLQI), number of (treatment-related) adverse events, FLG mutation status, NMF amount in stratum corneum and skin microbiota composition.;Timepoint(s) of evaluation of this end point: Baseline, week 2, week 4	—

Measure

Time frame

Secondary end point(s): percentage change in EASI score at week 4, EASI-75 at week 2 and week 4, Pruritus NRS, Patient Oriented Eczema Measure (POEM), Patient Global Assessment of Disease Severity (PGA), Health-related Quality of Life (DLQI), number of (treatment-related) adverse events, FLG mutation status, NMF amount in stratum corneum and skin microbiota composition.;Timepoint(s) of evaluation of this end point: Baseline, week 2, week 4

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Countries

Netherlands

Contacts

Public ContactMarijke Kamsteeg

Radboud University Medical Center

Marijke.Kamsteeg@radboudumc.nl+31243092670

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026