Proactive Treatment of Tacrolimus Ointment for Adult Facial Seborrheic Dermatitis
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Seborrheic Dermatitis |
Drug: Tacrolimus |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| Official Title: | Phase 4 Study of Proactive Treatment of Tacrolimus Ointment for Adult Facial Seborrheic Dermatitis |
- Clinical assessments of erythema, scaling, and pruritus [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
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.
| Enrollment: | 104 |
| Study Start Date: | November 2010 |
| Study Completion Date: | May 2011 |
| Primary Completion Date: | May 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| No Intervention: vehicle twice weekly | |
| Experimental: tacrolimus once weekly |
Drug: Tacrolimus
0.1% tacrolimus once-weekly application for 10 weeks
Other Name: protopic 0.1% ointment
|
| Experimental: tacrolimus twice weekly |
Drug: Tacrolimus
0.1% tacrolimus twice weekly application for 10 weeks
Other Name: protopic 0.1% ointment
|
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| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts 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
Contacts and Locations| Korea, Republic of | |
| Department of dermatology, Pusan National University Hospital | |
| Busan, Korea, Republic of, ASTIKRIKS012IPUSAN | |
| Study Chair: | Byung-Soo Kim, Ph.D. | Pusan National University Hospital |
More Information
No publications provided
| Responsible Party: | Pusan National University Hospital |
| ClinicalTrials.gov Identifier: | NCT01591070 History of Changes |
| Other Study ID Numbers: | PNUHDM |
| Study First Received: | April 25, 2012 |
| Last Updated: | August 7, 2012 |
| Health Authority: | Korea: Institutional Review Board |
Keywords provided by Pusan National University Hospital:
|
Facial seborrhoeic dermatitis, tacrolimus |
Additional relevant MeSH terms:
|
Dermatitis Dermatitis, Seborrheic Skin Diseases Sebaceous Gland Diseases Skin Diseases, Eczematous Skin Diseases, Papulosquamous |
Tacrolimus Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 19, 2013