Proactive Treatment of Tacrolimus Ointment for Adult Facial Seborrheic Dermatitis

Last updated: August 7, 2012
Sponsor: Pusan National University Hospital
Overall Status: Completed

Phase

4

Condition

Eczema (Atopic Dermatitis - Pediatric)

Allergy

Rash

Treatment

N/A

Clinical Study ID

NCT01591070
PNUHDM
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

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

Exclusion

Exclusion Criteria:

  • taking other systemic or topical treatments for facial seborrhoeic dermatitis withinthe 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

Study Design

Total Participants: 104
Study Start date:
November 01, 2010
Estimated Completion Date:
May 31, 2011

Study 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.

Connect with a study center

  • Department of dermatology, Pusan National University Hospital

    Busan, ASTIKRIKS012IPUSAN
    Korea, Republic of

    Site Not Available

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