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Completed

NCT Number: NCT02941432

Black Tea Compresses for 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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Dermatology, University of Lübeck

Lübeck, Schleswig-Holstein, 23538, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Black tea compress treatment

Other

Wet compresses with black tea applied 4-5 times daily to the face for 6 days

Primary outcomes

  1. Change in Facial Eczema Activity and Severity Index (patients with facial eczema)

    Time frame: days 0, 3 and 6

  2. Change in Perioral Dermatitis Severity Score (patients with perioral dermatitis)

    Time frame: days 0, 3 and 6

  3. Change in Investigator´s Global Assessment Score (all patients)

    Time frame: days 0, 3 and 6

  4. Change in Patient´s Self-Assessment Score (all patients)

    Time frame: days 0, 3 and 6

  5. Change in Visual Analog Scale for pruritus in the face (patients with facial eczema)

    Time frame: days 0, 3 and 6

  6. Change in Visual Analog Scale for tension feeling in the face (patients with perioral dermatitis)

    Time frame: days 0, 3 and 6

Secondary outcomes

  1. Side-effects

    Time frame: days 3 and 6

Sponsors and collaborators

Lead sponsor

University of Luebeck

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Oct 21, 2016
Registry last updated
Nov 6, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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