Proactive Treatment of Tacrolimus Ointment for Adult Facial Seborrheic Dermatitis
Phase 4 Study of Proactive Treatment of Tacrolimus Ointment for Adult Facial Seborrheic Dermatitis
1 other identifier
interventional
104
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Nov 2010
Shorter than P25 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2011
CompletedFirst Submitted
Initial submission to the registry
April 25, 2012
CompletedFirst Posted
Study publicly available on registry
May 3, 2012
CompletedAugust 8, 2012
August 1, 2012
6 months
April 25, 2012
August 7, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
12 weeks
Study Arms (3)
vehicle twice weekly
NO INTERVENTIONtacrolimus once weekly
EXPERIMENTALtacrolimus twice weekly
EXPERIMENTALInterventions
0.1% tacrolimus once-weekly application for 10 weeks
Eligibility Criteria
You may qualify if:
- at least 18 years of age with a diagnosis of facial seborrhoeic dermatitis
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of dermatology, Pusan National University Hospital
Busan, Busan, ASTIKRIKS012IPUSAN, South Korea
Related Publications (1)
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.
PMID: 23388687DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Byung-Soo Kim, Ph.D.
Pusan National University Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 25, 2012
First Posted
May 3, 2012
Study Start
November 1, 2010
Primary Completion
May 1, 2011
Study Completion
May 1, 2011
Last Updated
August 8, 2012
Record last verified: 2012-08