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Proactive Treatment of Tacrolimus Ointment for Adult Facial Seborrheic Dermatitis

Sponsor
Pusan National University Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT01591070
Collaborator
(none)
104
Enrollment
1
Location
3
Arms
5.9
Duration (Months)
17.5
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
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 Design

Study Type:
Interventional
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 :
Nov 1, 2010
Actual Primary Completion Date :
May 1, 2011
Actual Study Completion Date :
May 1, 2011

Arms and Interventions

Arm Intervention/Treatment
No Intervention: vehicle twice weekly
Experimental: tacrolimus once weekly

Drug: Tacrolimus
0.1% tacrolimus once-weekly application for 10 weeks
Other Names:
  • protopic 0.1% ointment

    		•
    Experimental: tacrolimus twice weekly

    Drug: Tacrolimus
    0.1% tacrolimus twice weekly application for 10 weeks
    Other Names:
  • protopic 0.1% ointment

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Clinical assessments of erythema, scaling, and pruritus [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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Pusan National University Hospital
    ClinicalTrials.gov Identifier:
    NCT01591070
    Other Study ID Numbers:
    • PNUHDM
    First Posted:
    May 3, 2012
    Last Update Posted:
    Aug 8, 2012
    Last Verified:
    Aug 1, 2012
    Keywords provided by Pusan National University Hospital
    Facial seborrhoeic dermatitis, tacrolimus
    Additional relevant MeSH terms:
    Dermatitis
    Dermatitis, Seborrheic
    Tacrolimus

    Study Results

    No Results Posted as of Aug 8, 2012