Clinical trial NCT01591070: Proactive Treatment of Tacrolimus Ointment for Adult Facial Seborrheic Dermatitis
Official title: Phase 4 Study of Proactive Treatment of Tacrolimus Ointment for Adult Facial Seborrheic Dermatitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Seborrheic Dermatitis
Keywords: Facial seborrhoeic dermatitis, tacrolimus
Lead sponsor: Pusan National University Hospital
Sponsor class: OTHER
First posted: 2012-05-03
Enrollment: 104
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Clinical assessments of erythema, scaling, and pruritus
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Busan
country: Korea, Republic of
facility: Department of dermatology, Pusan National University Hospital
Study officials:
affiliation: Pusan National University Hospital
name: Byung-Soo Kim, Ph.D.
role: STUDY_CHAIR
References:
citation: 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.