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Black Tea Compresses for Facial Eczema and Perioral Dermatitis

Primary Purpose

Eczema, Dermatitis

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Black tea compress treatment
Sponsored by
University of Luebeck
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Eczema, Dermatitis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • clinical diagnosis of facial eczema or perioral dermatitis
  • minimum age of 18 years
  • patient is capable of granting informed consent
  • patient is expected to comply with the trial treatment protocol
  • for outpatients: close place of residence

Exclusion Criteria:

  • initiation or increase of systemic immunosuppressive or antibiotic treatment necessary
  • psychiatric disease or other factors making poor patient compliance probable
  • participation in another clinical trial within the past 6 months

Sites / Locations

  • Department of Dermatology, University of Lübeck

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Black tea

Arm Description

Black tea compress treatment

Outcomes

Primary Outcome Measures

Change in Facial Eczema Activity and Severity Index (patients with facial eczema)
Change in Perioral Dermatitis Severity Score (patients with perioral dermatitis)
Change in Investigator´s Global Assessment Score (all patients)
Change in Patient´s Self-Assessment Score (all patients)
Change in Visual Analog Scale for pruritus in the face (patients with facial eczema)
Change in Visual Analog Scale for tension feeling in the face (patients with perioral dermatitis)

Secondary Outcome Measures

Side-effects

Full Information

First Posted
October 16, 2016
Last Updated
November 3, 2017
Sponsor
University of Luebeck
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1. Study Identification

Unique Protocol Identification Number
NCT02941432
Brief Title
Black Tea Compresses for Facial Eczema and Perioral Dermatitis
Official Title
Pilot Study of Effects and Tolerance of Black Tea Compress Treatment in Facial Eczema and Perioral Dermatitis
Study Type
Interventional

2. Study Status

Record Verification Date
November 2017
Overall Recruitment Status
Completed
Study Start Date
September 1, 2016 (undefined)
Primary Completion Date
September 1, 2017 (Actual)
Study Completion Date
September 1, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Luebeck

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Facial eczema and perioral dermatitis are clinical entities that develop exclusively in the face and present a special therapeutic challenge. Topical corticosteroids that are commonly applied to treat eczema/dermatitis at other body sites are best avoided in the face, as they may result in rapid atrophy of facial skin and in the long term rather aggravate facial dermatoses. Black tea compresses have been successfully used by German-speaking dermatologists to treat facial eczema/dermatitis for decades. The precise mechanism of action is unknown but is presumably based on astringent properties of tannins in the black tea and on the antiinflammatory action of a wet compress as such. This therapy is cheap, universally available and practically free of side-effects. Despite these perceived advantages the effects and tolerance of black tea compresses have not been formally studied to date. Therefore, the investigators plan to treat 25 patients with facial eczema/perioral dermatitis over a period of 6 days each within the current trial. The disease activity will be assessed before, during and after completion of treatment using several clinical scores. In addition, side-effects, if any, will be documented.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Eczema, Dermatitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
26 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Black tea
Arm Type
Other
Arm Description
Black tea compress treatment
Intervention Type
Other
Intervention Name(s)
Black tea compress treatment
Intervention Description
Wet compresses with black tea applied 4-5 times daily to the face for 6 days
Primary Outcome Measure Information:
Title
Change in Facial Eczema Activity and Severity Index (patients with facial eczema)
Time Frame
days 0, 3 and 6
Title
Change in Perioral Dermatitis Severity Score (patients with perioral dermatitis)
Time Frame
days 0, 3 and 6
Title
Change in Investigator´s Global Assessment Score (all patients)
Time Frame
days 0, 3 and 6
Title
Change in Patient´s Self-Assessment Score (all patients)
Time Frame
days 0, 3 and 6
Title
Change in Visual Analog Scale for pruritus in the face (patients with facial eczema)
Time Frame
days 0, 3 and 6
Title
Change in Visual Analog Scale for tension feeling in the face (patients with perioral dermatitis)
Time Frame
days 0, 3 and 6
Secondary Outcome Measure Information:
Title
Side-effects
Time Frame
days 3 and 6

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: clinical diagnosis of facial eczema or perioral dermatitis minimum age of 18 years patient is capable of granting informed consent patient is expected to comply with the trial treatment protocol for outpatients: close place of residence Exclusion Criteria: initiation or increase of systemic immunosuppressive or antibiotic treatment necessary psychiatric disease or other factors making poor patient compliance probable participation in another clinical trial within the past 6 months
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Iakov Shimanovich, MD
Organizational Affiliation
University of Lübeck
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Dermatology, University of Lübeck
City
Lübeck
State/Province
Schleswig-Holstein
ZIP/Postal Code
23538
Country
Germany

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
It is planned to publish the study results, including anonymized clinical patient data and photographs in a scientific journal.
Citations:
PubMed Identifier
30668184
Citation
Witte M, Krause L, Zillikens D, Shimanovich I. Black tea dressings - a rapidly effective treatment for facial dermatitis. J Dermatolog Treat. 2019 Dec;30(8):785-789. doi: 10.1080/09546634.2019.1573306. Epub 2019 Feb 3.
Results Reference
derived

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Black Tea Compresses for Facial Eczema and Perioral Dermatitis

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