Proactive Treatment of Tacrolimus Ointment for Adult Facial Seborrheic Dermatitis

Phase 4

Completed

• Conditions: Seborrheic Dermatitis
• Interventions: Drug: Tacrolimus

• Registration Number: NCT01591070
• Lead Sponsor: Pusan National University Hospital

Brief Summary

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

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2010-11
• Primary Completion: 2011-05
• Study Completion: 2011-05
• Study First Submitted: 2012-04-25
• Study First Submitted QC: 2012-05-02
• Study First Posted: 2012-05-03
• Status Verified: 2012-08
• Last Update Submitted: 2012-08-07
• Last Update Posted: 2012-08-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 104

Inclusion Criteria

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
tacrolimus once weekly	Tacrolimus	-
tacrolimus twice weekly	Tacrolimus	-

Primary Outcome Measures

Name	Time	Method
Clinical assessments of erythema, scaling, and pruritus	12 weeks	The clinical assessments of erythema, scaling, and pruritus will be evaluated by investigator using 4-point scale: 0 (absent), 1 (mild), 2 (moderate), or 3 (severe).; Maintenance of stabilised facial Seborroheic dermatitis will be considered those patients who showed significant improvement of clinical assessment in erythema, scaling, and pruritus compared with the baseline values.

Trial Locations

Locations (1)

Department of dermatology, Pusan National University Hospital; 🇰🇷 Busan, Korea, Republic of