Eczema, DermatitisNCT02941432
Black Tea Compresses for Facial Eczema and Perioral Dermatitis
A study testing Black tea compress treatment in people with Eczema, Dermatitis, run by University of Luebeck at 1 site in Germany.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Eczema, Dermatitis
- What is being tested?
- Black tea compress treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteGermany
- Study dates
- 1 Sep 2016to 1 Sep 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Germany1 site
Department of Dermatology, University of Lübeck
Lübeck, Schleswig-Holstein, 23538
About this study
Official title: 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.
- Conditions
- Eczema, Dermatitis
- Being tested
- Black tea compress treatment
- Medical subject headings
- Eczema, Dermatitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Black tea compress treatmentOther
Wet compresses with black tea applied 4-5 times daily to the face for 6 days
| Study group | Role | What they receive |
|---|---|---|
| Black tea | Other | Black tea compress treatment Receives: Other: Black tea compress treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Facial Eczema Activity and Severity Index (patients with facial eczema)
Measured: days 0, 3 and 6
Change in Perioral Dermatitis Severity Score (patients with perioral dermatitis)
Measured: days 0, 3 and 6
Change in Investigator´s Global Assessment Score (all patients)
Measured: days 0, 3 and 6
Change in Patient´s Self-Assessment Score (all patients)
Measured: days 0, 3 and 6
Change in Visual Analog Scale for pruritus in the face (patients with facial eczema)
Measured: days 0, 3 and 6
Change in Visual Analog Scale for tension feeling in the face (patients with perioral dermatitis)
Measured: days 0, 3 and 6
Secondary outcomes (1)
Side-effects
Measured: days 3 and 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2016 (estimated)
- Study start1 Sep 2016
- Primary completion1 Sep 2017
- Study completion1 Sep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Eczema, DermatitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Luebeck
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Iakov Shimanovich, MD, University of Luebeck
- Investigators
- Iakov Shimanovich, MD, Principal investigator, University of Lübeck
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02941432
- Sponsor's protocol ID
- Black Tea Trial
- Status last verified
- Nov 2017
- First submitted
- 16 Oct 2016
- Last updated
- 6 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: It is planned to publish the study results, including anonymized clinical patient data and photographs in a scientific journal.
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.
PubMed 30668184
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of Effects and Tolerance of Black Tea Compress Treatment in Facial Eczema and Perioral Dermatitis
- ClinicalTrials.gov ID
- NCT02941432
- Acronym / sponsor ID
- Black Tea Trial
- Conditions
- Eczema, Dermatitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- University of LuebeckUniversity, hospital or other
- Study start
- 1 Sep 2016
- Primary completion
- 1 Sep 2017 (actual)
- Study completion
- 1 Sep 2017 (actual)
- First posted
- 21 Oct 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Black tea | Other | Other: Black tea compress treatmentBlack tea compress treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Black tea compress treatmentWet compresses with black tea applied 4-5 times daily to the face for 6 days | Other | Black tea |
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
1 secondary outcome
Side-effects
Time frame: days 3 and 6
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2017.
- Derived from this study: PubMed 30668184Witte 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.
- Individual participant dataSharing planned: Yes. It is planned to publish the study results, including anonymized clinical patient data and photographs in a scientific journal.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Iakov Shimanovich, MD principal investigator
University of Lübeck
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Black tea compress treatment in people with Eczema, Dermatitis, run by University of Luebeck at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Facial Eczema Activity and Severity Index (patients with facial eczema) (time frame: days 0, 3 and 6). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02941432, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2017.