Seborrheic Dermatitis
Conditions
Keywords
Facial seborrhoeic dermatitis, tacrolimus
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.
Interventions
DRUGTacrolimus
0.1% tacrolimus once-weekly application for 10 weeks
Sponsors
Pusan National University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical assessments of erythema, scaling, and pruritus | 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. |
Countries
South Korea
Outcome results
None listed