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Proactive Treatment of Tacrolimus Ointment for Adult Facial Seborrheic Dermatitis

Primary Purpose

Seborrheic Dermatitis

Status
Completed
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Tacrolimus
Tacrolimus
Sponsored by
Pusan National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Seborrheic Dermatitis focused on measuring Facial seborrhoeic dermatitis, tacrolimus

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Department of dermatology, Pusan National University Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

Experimental

Experimental

Arm Label

vehicle twice weekly

tacrolimus once weekly

tacrolimus twice weekly

Arm Description

Outcomes

Primary Outcome Measures

Clinical assessments of erythema, scaling, and pruritus
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.

Secondary Outcome Measures

Full Information

First Posted
April 25, 2012
Last Updated
August 7, 2012
Sponsor
Pusan National University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01591070
Brief Title
Proactive Treatment of Tacrolimus Ointment for Adult Facial Seborrheic Dermatitis
Official Title
Phase 4 Study of Proactive Treatment of Tacrolimus Ointment for Adult Facial Seborrheic Dermatitis
Study Type
Interventional

2. Study Status

Record Verification Date
August 2012
Overall Recruitment Status
Completed
Study Start Date
November 2010 (undefined)
Primary Completion Date
May 2011 (Actual)
Study Completion Date
May 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pusan National University Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Seborrheic Dermatitis
Keywords
Facial seborrhoeic dermatitis, tacrolimus

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
104 (Actual)

8. Arms, Groups, and Interventions

Arm Title
vehicle twice weekly
Arm Type
No Intervention
Arm Title
tacrolimus once weekly
Arm Type
Experimental
Arm Title
tacrolimus twice weekly
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Tacrolimus
Other Intervention Name(s)
protopic 0.1% ointment
Intervention Description
0.1% tacrolimus once-weekly application for 10 weeks
Intervention Type
Drug
Intervention Name(s)
Tacrolimus
Other Intervention Name(s)
protopic 0.1% ointment
Intervention Description
0.1% tacrolimus twice weekly application for 10 weeks
Primary Outcome Measure Information:
Title
Clinical assessments of erythema, scaling, and pruritus
Description
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.
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Byung-Soo Kim, Ph.D.
Organizational Affiliation
Pusan National University Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Department of dermatology, Pusan National University Hospital
City
Busan
ZIP/Postal Code
ASTIKRIKS012IPUSAN
Country
Korea, Republic of

12. IPD Sharing Statement

Citations:
PubMed Identifier
23388687
Citation
Kim TW, Mun JH, Jwa SW, Song M, Kim HS, Ko HC, Kim MB, Song KH, Lee SK, Seo JK, Lee D, Kim BS. Proactive treatment of adult facial seborrhoeic dermatitis with 0.1% tacrolimus ointment: randomized, double-blind, vehicle-controlled, multi-centre trial. Acta Derm Venereol. 2013 Sep 4;93(5):557-61. doi: 10.2340/00015555-1532.
Results Reference
derived

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Proactive Treatment of Tacrolimus Ointment for Adult Facial Seborrheic Dermatitis

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