Skip to main content
OpenTrials
Completed

NCT Number: NCT01591070

Proactive Treatment of Tacrolimus Ointment for Adult Facial Seborrheic Dermatitis

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Department of dermatology, Pusan National University Hospital

Busan, ASTIKRIKS012IPUSAN, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Tacrolimus

Drug

0.1% tacrolimus once-weekly application for 10 weeks

Other names: protopic 0.1% ointment

Primary outcomes

  1. Clinical assessments of erythema, scaling, and pruritus

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Pusan National University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
May 3, 2012
Registry last updated
Aug 8, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.