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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| vehicle twice weekly | No Intervention | ||
| tacrolimus once weekly | Experimental |
| |
| tacrolimus twice weekly | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tacrolimus | Drug | 0.1% tacrolimus once-weekly application for 10 weeks |
|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Byung-Soo Kim, Ph.D. | Pusan National University Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of dermatology, Pusan National University Hospital | Busan | Busan | ASTIKRIKS012IPUSAN | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23388687 | Derived | 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. |
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| ID | Term |
|---|---|
| D012628 | Dermatitis, Seborrheic |
| ID | Term |
|---|---|
| D003872 | Dermatitis |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D012625 | Sebaceous Gland Diseases |
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| ID | Term |
|---|---|
| D016559 | Tacrolimus |
| D009824 | Ointments |
| ID | Term |
|---|---|
| D018942 | Macrolides |
| D007783 | Lactones |
| D009930 | Organic Chemicals |
| D004304 | Dosage Forms |
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| Tacrolimus | Drug | 0.1% tacrolimus twice weekly application for 10 weeks |
|
|
| D017443 |
| Skin Diseases, Eczematous |
| D017444 | Skin Diseases, Papulosquamous |
| D004364 |
| Pharmaceutical Preparations |