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Black Tea Compresses for Facial Eczema and Perioral Dermatitis

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ClinicalTrials.gov Identifier: NCT02941432
Recruitment Status : Completed
First Posted : October 21, 2016
Last Update Posted : November 6, 2017
Sponsor:
Information provided by (Responsible Party):
Iakov Shimanovich, MD, University of Luebeck

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.

Condition or disease Intervention/treatment Phase
Eczema, Dermatitis Other: Black tea compress treatment Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 26 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pilot Study of Effects and Tolerance of Black Tea Compress Treatment in Facial Eczema and Perioral Dermatitis
Study Start Date : September 1, 2016
Actual Primary Completion Date : September 1, 2017
Actual Study Completion Date : September 1, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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




Primary Outcome Measures :
  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 Outcome Measures :
  1. Side-effects [ Time Frame: days 3 and 6 ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02941432


Locations
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Germany
Department of Dermatology, University of Lübeck
Lübeck, Schleswig-Holstein, Germany, 23538
Sponsors and Collaborators
University of Luebeck
Investigators
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Principal Investigator: Iakov Shimanovich, MD University of Lübeck

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Iakov Shimanovich, MD, Attending Dermatologist, University of Luebeck
ClinicalTrials.gov Identifier: NCT02941432     History of Changes
Other Study ID Numbers: Black Tea Trial
First Posted: October 21, 2016    Key Record Dates
Last Update Posted: November 6, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: It is planned to publish the study results, including anonymized clinical patient data and photographs in a scientific journal.

Additional relevant MeSH terms:
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Dermatitis
Eczema
Dermatitis, Perioral
Skin Diseases
Skin Diseases, Eczematous
Facial Dermatoses