Proactive Treatment of Tacrolimus Ointment for Adult Facial Seborrheic Dermatitis

Study Overview
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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.

Official Title
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Phase 4 Study of Proactive Treatment of Tacrolimus Ointment for Adult Facial Seborrheic Dermatitis

Conditions
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Seborrheic Dermatitis

Intervention / Treatment
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* Drug: Tacrolimus
* Drug: Tacrolimus


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: vehicle twice weekly<br> | |
| Experimental: tacrolimus once weekly<br> | Drug: Tacrolimus<br>* 0.1% tacrolimus once-weekly application for 10 weeks<br>* Other names: protopic 0.1% ointment;|
| Experimental: tacrolimus twice weekly<br> | Drug: Tacrolimus<br>* 0.1% tacrolimus twice weekly application for 10 weeks<br>* Other names: protopic 0.1% ointment;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical assessments of erythema, scaling, and pruritus | 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. | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Facial seborrhoeic dermatitis, tacrolimus