Clinical Trial: Black Tea Compresses for Facial Eczema and Perioral Dermatitis

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

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

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.

Detailed Summary:
Sponsor: University of Luebeck

Current Primary Outcome:

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


Original Primary Outcome: Same as current

Current Secondary Outcome: Side-effects [ Time Frame: days 3 and 6 ]

Original Secondary Outcome: Same as current

Information By: University of Luebeck

Dates:
Date Received: October 16, 2016
Date Started: September 2016
Date Completion: September 2018
Last Updated: October 20, 2016
Last Verified: October 2016