Black Tea Compresses for Facial Eczema and Perioral Dermatitis

Pilot Study of Effects and Tolerance of Black Tea Compress Treatment in Facial Eczema and Perioral Dermatitis

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.

Study Overview

• Status: Completed
• Conditions: Eczema, Dermatitis
• Intervention / Treatment: Other: Black tea compress treatment

• Study Type: Interventional
• Enrollment (Actual): 26
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Schleswig-Holstein
    • Lübeck, Schleswig-Holstein, Germany, 23538
      • Department of Dermatology, University of Lübeck

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Black tea; Black tea compress treatment	Other: Black tea compress treatment; Wet compresses with black tea applied 4-5 times daily to the face for 6 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change in Facial Eczema Activity and Severity Index (patients with facial eczema)	days 0, 3 and 6
Change in Perioral Dermatitis Severity Score (patients with perioral dermatitis)	days 0, 3 and 6
Change in Investigator´s Global Assessment Score (all patients)	days 0, 3 and 6
Change in Patient´s Self-Assessment Score (all patients)	days 0, 3 and 6
Change in Visual Analog Scale for pruritus in the face (patients with facial eczema)	days 0, 3 and 6
Change in Visual Analog Scale for tension feeling in the face (patients with perioral dermatitis)	days 0, 3 and 6

Secondary Outcome Measures

Outcome Measure	Time Frame
Side-effects	days 3 and 6

Collaborators and Investigators

• Sponsor: University of Luebeck
• Investigators: Principal Investigator: Iakov Shimanovich, MD, University of Lübeck

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: September 1, 2016
• Primary Completion (Actual): September 1, 2017
• Study Completion (Actual): September 1, 2017

Study Registration Dates

• First Submitted: October 16, 2016
• First Submitted That Met QC Criteria: October 20, 2016
• First Posted (Estimate): October 21, 2016

Study Record Updates

• Last Update Posted (Actual): November 6, 2017
• Last Update Submitted That Met QC Criteria: November 3, 2017
• Last Verified: November 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Skin Diseases, Eczematous; Facial Dermatoses; Dermatitis; Eczema; Dermatitis, Perioral
• Other Study ID Numbers: Black Tea Trial

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: It is planned to publish the study results, including anonymized clinical patient data and photographs in a scientific journal.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No