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Proactive Treatment of Tacrolimus Ointment for Adult Facial Seborrheic Dermatitis

NCT ID: NCT01591070

Last Updated: 2012-08-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

104 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-11-30

Study Completion Date

2011-05-31

Brief Summary

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The purpose of this study is to determine whether proactive use of 0.1% tacrolimus ointment once or twice weekly can keep adult facial SD in remission and reduce the incidence of exacerbation.

Detailed Description

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Seborrhoeic dermatitis (SD) is a common chronic papulosquamous dermatosis, affecting 2% to 10% of the adult population, mainly those between the ages of 20 and 50 years with a male bias. The affected skin appears erythematous and oedematous, covered with yellow-brown scales, and is often accompanied by pruritus. It typically affects areas containing sebaceous glands, particularly the scalp, ears, face, chest, and intertriginous areas. SD has a chronic course, and relapse is common. Therefore, therapy is directed toward reducing the symptoms or aggravating factors of SD, such as loosening and removal of scales and crusts, inhibition of yeast colonization, control of secondary infection, and reduction of erythema and pruritus. Standard topical treatments for SD include corticosteroids and anti-mycotic medications. However, the chronic use of topical corticosteroids particularly on the face could result in undesirable outcomes, such as telangiectasia, atrophy, striae, peri-oral dermatitis, or tachyphylaxis, and early relapse after discontinuation of treatment. SD relapse prevention strategies have not yet been established, so the investigators suspected that intermittent use of tacrolimus ointment can be effective in preventing SD relapse.

Conditions

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Seborrheic Dermatitis

Keywords

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Facial seborrhoeic dermatitis, tacrolimus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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vehicle twice weekly

Group Type NO_INTERVENTION

No interventions assigned to this group

tacrolimus once weekly

Group Type EXPERIMENTAL

Tacrolimus

Intervention Type DRUG

0.1% tacrolimus once-weekly application for 10 weeks

tacrolimus twice weekly

Group Type EXPERIMENTAL

Tacrolimus

Intervention Type DRUG

0.1% tacrolimus twice weekly application for 10 weeks

Interventions

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Tacrolimus

0.1% tacrolimus once-weekly application for 10 weeks

Intervention Type DRUG

Tacrolimus

0.1% tacrolimus twice weekly application for 10 weeks

Intervention Type DRUG

Other Intervention Names

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protopic 0.1% ointment protopic 0.1% ointment

Eligibility Criteria

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Inclusion Criteria

* at least 18 years of age with a diagnosis of facial seborrhoeic dermatitis

Exclusion Criteria

* taking other systemic or topical treatments for facial seborrhoeic dermatitis within the previous 4 weeks
* a known allergy to the components of tacrolimus ointment
* malignant neoplasm; immunologic abnormality
* active infection
* other definitive cutaneous findings such as erythroderma, acne, and psoriasis
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pusan National University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Byung-Soo Kim, Ph.D.

Role: STUDY_CHAIR

Pusan National University Hospital

Locations

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Department of dermatology, Pusan National University Hospital

Busan, Busan, South Korea

Site Status

Countries

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South Korea

References

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Kim TW, Mun JH, Jwa SW, Song M, Kim HS, Ko HC, Kim MB, Song KH, Lee SK, Seo JK, Lee D, Kim BS. Proactive treatment of adult facial seborrhoeic dermatitis with 0.1% tacrolimus ointment: randomized, double-blind, vehicle-controlled, multi-centre trial. Acta Derm Venereol. 2013 Sep 4;93(5):557-61. doi: 10.2340/00015555-1532.

Reference Type DERIVED
PMID: 23388687 (View on PubMed)

Other Identifiers

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PNUHDM

Identifier Type: -

Identifier Source: org_study_id