Efficacy of topical coal tar in children with atopic dermatitis

A randomized controlled pilot study comparing the efficacy of topical coal tar to topical corticosteroids in children aged 1 to < 16 years with moderate-severe atopic dermatitis.

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2016-004542-28-NL

Enrollment

Registered

2017-01-25

Start date

2017-09-14

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

Interventions

Trade Name: Eumovate Ointment (clobetasone butyrate 0.05%) Product Name: Emovate ointment (clobetasone butyrate 0.05%) Pharmaceutical Form: Ointment Trade Name: Hydrocortisone acetate 1% ointment Pro

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Male or female patients aged between 1 and 7.1 Are the trial subjects under 18? yes Number of subjects for this age range: 80 F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

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 moderate potency topical corticosteroids

Design outcomes

Primary

Measure	Time frame
Main Objective: To evaluate efficacy of topical treatment with coal tar compared to topical treatment with corticosteroids in children aged 1 to <16 years with moderate to severe AD, based on the percentage change in Eczema Area and Severity Index (EASI) at week 2. ;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;Secondary Objective: Percentage change in EASI at week 4, the proportion of patients with EASI-75 at week 2 and week 4, decrease in VAS score for pruritus, changes in patient-reported outcome (POEM and Patient PGA), changes in quality of life (CDLQI), changes in family impact (DFI) 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 to evaluate changes in Natural Moisturizing Factors (NMF) in the stratum corneum and changes in skin microbiota between patients treated with topical coal tar and topical corticosteroids.	—

Measure

Time frame

Main Objective: To evaluate efficacy of topical treatment with coal tar compared to topical treatment with corticosteroids in children aged 1 to <16 years with moderate to severe AD, based on the percentage change in Eczema Area and Severity Index (EASI) at week 2. ;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;Secondary Objective: Percentage change in EASI at week 4, the proportion of patients with EASI-75 at week 2 and week 4, decrease in VAS score for pruritus, changes in patient-reported outcome (POEM and Patient PGA), changes in quality of life (CDLQI), changes in family impact (DFI) 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 to evaluate changes in Natural Moisturizing Factors (NMF) in the stratum corneum and changes in skin microbiota between patients treated with topical coal tar and topical corticosteroids.

—

Secondary

Measure	Time frame
Secondary end point(s): Secondary outcomes: percentage change in EASI score at week 4, EASI-75 at week 2 and week 4, Pruritus VAS, Patient Oriented Eczema Measure (POEM), Patient Global Assessment of Disease Severity (PGA), Health-related Quality of Life (CDLQI), Family impact of childhood Atopic Dermatitis (DFI), 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): Secondary outcomes: percentage change in EASI score at week 4, EASI-75 at week 2 and week 4, Pruritus VAS, Patient Oriented Eczema Measure (POEM), Patient Global Assessment of Disease Severity (PGA), Health-related Quality of Life (CDLQI), Family impact of childhood Atopic Dermatitis (DFI), 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

—

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