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Proactive Treatment of Tacrolimus Ointment for Adult Facial Seborrheic Dermatitis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01591070
Recruitment Status : Completed
First Posted : May 3, 2012
Last Update Posted : August 8, 2012
Sponsor:
Information provided by (Responsible Party):
Pusan National University Hospital

Tracking Information
First Submitted Date  ICMJE April 25, 2012
First Posted Date  ICMJE May 3, 2012
Last Update Posted Date August 8, 2012
Study Start Date  ICMJE November 2010
Actual Primary Completion Date May 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 2, 2012)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01591070 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Proactive Treatment of Tacrolimus Ointment for Adult Facial Seborrheic Dermatitis
Official Title  ICMJE Phase 4 Study of Proactive Treatment of Tacrolimus Ointment for Adult Facial Seborrheic Dermatitis
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Seborrheic Dermatitis
Intervention  ICMJE
  • Drug: Tacrolimus
    0.1% tacrolimus once-weekly application for 10 weeks
    Other Name: protopic 0.1% ointment
  • Drug: Tacrolimus
    0.1% tacrolimus twice weekly application for 10 weeks
    Other Name: protopic 0.1% ointment
Study Arms  ICMJE
  • No Intervention: vehicle twice weekly
  • Experimental: tacrolimus once weekly
    Intervention: Drug: Tacrolimus
  • Experimental: tacrolimus twice weekly
    Intervention: Drug: Tacrolimus
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 2, 2012)
104
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE May 2011
Actual Primary Completion Date May 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01591070
Other Study ID Numbers  ICMJE PNUHDM
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pusan National University Hospital
Study Sponsor  ICMJE Pusan National University Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Byung-Soo Kim, Ph.D. Pusan National University Hospital
PRS Account Pusan National University Hospital
Verification Date August 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP