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Proactive Treatment of Tacrolimus Ointment for Adult Facial Seborrheic Dermatitis

P

Pusan National University

Status and phase

Completed
Phase 4

Conditions

Seborrheic Dermatitis

Treatments

Drug: Tacrolimus

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

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.

Full 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.

Enrollment

104 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Double Blind

104 participants in 3 patient groups

vehicle twice weekly
No Intervention group
tacrolimus once weekly
Experimental group
Treatment:
Drug: Tacrolimus
Drug: Tacrolimus
tacrolimus twice weekly
Experimental group
Treatment:
Drug: Tacrolimus
Drug: Tacrolimus

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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