Proactive Treatment of Tacrolimus Ointment for Adult Facial Seborrheic Dermatitis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pusan National University Hospital
ClinicalTrials.gov Identifier:
NCT01591070
First received: April 25, 2012
Last updated: August 7, 2012
Last verified: August 2012
  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

Resource links provided by NLM:


Further study details as provided by Pusan National University Hospital:

Primary Outcome Measures:
  • 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
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01591070

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

No publications provided by Pusan National University Hospital

Additional 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
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 September 18, 2014