Effect of coal tar ointment in the skin barrier repair mechanisms.

Pilot study on the effect of prophylactic versus therapeutic treatment with coal tar and vaseline lanette ointment on the skin barrier repair mechanisms in absence of a chronic inflammatory component.

Status

Not yet recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2017-002223-25-NL

Enrollment

Registered

2018-04-05

Start date

2018-05-25

Completion date

Unknown

Last updated

2018-06-05

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

Conditions

Atopic dermatits MedDRA version: 20.0 Level: LLT Classification code 10003639 Term: Atopic dermatitis System Organ Class: 100000004858 MedDRA version: 20.0 Level: LLT Classification code 10003640 Term: Atopic dermatitis and related conditions System Organ Class: 100000004858

Interventions

Trade Name: Pix lihantracis 5% in cremor vaselini lanette FNA Product Name: Pix lihantracis 5% in cremor vaselini lanette FNA Pharmaceutical Form: Cream

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Males and females in the age of 18-35 years - Fitzpatrick skin type 1-3 - Caucasian race Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 20 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: - Presence of inflammatory skin disease - Fitzpatrick skin type 4-6 - Hypersensitivity and/or intolerance to topical coal tar

Design outcomes

Primary

Measure	Time frame
Main Objective: To study if the induction of skin barrier proteins, like FLG, by coal tar leads to an improved skin barrier repair and function in the absence of a chronic inflammatory component. ;Secondary Objective: Not applicable. ;Primary end point(s): Average difference in transepidermal water loss (TEWL) and 'natural moisturizing factors' (NMF) after prophylactic and therapeutic treatment with coal tar ointment or the vehicle during two to four days after skin barrier disruption by tapestripping of the skin. ;Timepoint(s) of evaluation of this end point: Day 2 (48 hours) and day 4 (96 hours)	—

Measure

Time frame

Main Objective: To study if the induction of skin barrier proteins, like FLG, by coal tar leads to an improved skin barrier repair and function in the absence of a chronic inflammatory component. ;Secondary Objective: Not applicable. ;Primary end point(s): Average difference in transepidermal water loss (TEWL) and 'natural moisturizing factors' (NMF) after prophylactic and therapeutic treatment with coal tar ointment or the vehicle during two to four days after skin barrier disruption by tapestripping of the skin. ;Timepoint(s) of evaluation of this end point: Day 2 (48 hours) and day 4 (96 hours)

—

Secondary

Measure	Time frame
Secondary end point(s): 1. Epidermal thickness and stratum corneum thickness due to coal tar and vehicle treatment 2. Expression of skin barrier genes and proteins due to coal tar and vehicle treatment 3. Non-invasive analysis of stratum corneum hydration due to coal tar and vehicle treatment 4. Non-invasive analysis of stratum corneum cohesion due to coal tar and vehicle treatment 5. Non-invasive analysis of corneocyte morphology due to coal tar and vehicle treatment 6. Macroscopic analysis of the tapestripped skin after coal tar and vehicle treatment 7. Non-invasive analysis of cytokines in the stratum corneum after coal tar and vehicle treatment;Timepoint(s) of evaluation of this end point: Day 2 (48 hours) and day 4 (96 hours)	—

Measure

Time frame

Secondary end point(s): 1. Epidermal thickness and stratum corneum thickness due to coal tar and vehicle treatment 2. Expression of skin barrier genes and proteins due to coal tar and vehicle treatment 3. Non-invasive analysis of stratum corneum hydration due to coal tar and vehicle treatment 4. Non-invasive analysis of stratum corneum cohesion due to coal tar and vehicle treatment 5. Non-invasive analysis of corneocyte morphology due to coal tar and vehicle treatment 6. Macroscopic analysis of the tapestripped skin after coal tar and vehicle treatment 7. Non-invasive analysis of cytokines in the stratum corneum after coal tar and vehicle treatment;Timepoint(s) of evaluation of this end point: Day 2 (48 hours) and day 4 (96 hours)

—

Countries

Netherlands

Contacts

Public ContactTessa Kouwenhoven

Radboud University Medical Center

Tessa.Kouwenhoven@radboudumc.nl+31243610265

Outcome results

None listed

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