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Proactive Treatment of Tacrolimus Ointment for Adult Facial Seborrheic Dermatitis

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ClinicalTrials.gov Identifier: NCT01591070
Recruitment Status : Completed
First Posted : May 3, 2012
Last Update Posted : August 8, 2012
Information provided by (Responsible Party):
Pusan National University Hospital

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.

Condition or disease Intervention/treatment Phase
Seborrheic Dermatitis Drug: Tacrolimus Phase 4

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 104 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Phase 4 Study of Proactive Treatment of Tacrolimus Ointment for Adult Facial Seborrheic Dermatitis
Study Start Date : November 2010
Primary Completion Date : May 2011
Study Completion Date : May 2011

Resource links provided by the National Library of Medicine

Drug Information available for: Tacrolimus
U.S. FDA Resources

Arm Intervention/treatment
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

Primary Outcome Measures :
  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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01591070

Korea, Republic of
Department of dermatology, Pusan National University Hospital
Busan, Korea, Republic of, ASTIKRIKS012IPUSAN
Sponsors and Collaborators
Pusan National University Hospital
Study Chair: Byung-Soo Kim, Ph.D. Pusan National University Hospital

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Pusan National University Hospital
ClinicalTrials.gov Identifier: NCT01591070     History of Changes
Other Study ID Numbers: PNUHDM
First Posted: May 3, 2012    Key Record Dates
Last Update Posted: August 8, 2012
Last Verified: August 2012

Keywords provided by Pusan National University Hospital:
Facial seborrhoeic dermatitis, tacrolimus

Additional relevant MeSH terms:
Dermatitis, Seborrheic
Skin Diseases
Sebaceous Gland Diseases
Skin Diseases, Eczematous
Skin Diseases, Papulosquamous
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Calcineurin Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action