Efficacy and Safety of Fucicort® Lipid Cream Compared to Combination Treatment With Fucidin® Cream Followed by Betamethasone (Lianbang Beisong®) Cream and Fucicort® Lipid Cream Vehicle in Clinically Infected Atopic Dermatitis/Eczema

Last updated: February 21, 2025
Sponsor: LEO Pharma
Overall Status: Terminated

Phase

3

Condition

Allergy

Atopic Dermatitis

Scalp Disorders

Treatment

Fucicort® Lipid cream

Fucicort® Lipid cream vehicle

betamethasone (Lianbang Beisong®) cream

Clinical Study ID

NCT03395132
FCF-38
  • Ages 2-65
  • All Genders

Study Summary

The trial is designed to compare the efficacy and safety of Fucicort® Lipid cream with the combination treatment of Fucidin® cream followed by betamethasone (Lianbang Beisong®) cream, or Fucicort® Lipid cream vehicle, when applied twice daily for two weeks. The trial is designed to demonstrate that treatment with Fucicort® Lipid cream is not inferior to the combination treatment with the mono component drugs, Fucidin® cream followed by betamethasone (Lianbang Beisong®) cream and that treatment with Fucicort® Lipid cream is superior to the treatment with Fucicort® Lipid cream vehicle. This is a 3-arm, parallel group, active- and vehicle-controlled trial comparing the efficacy and safety after 14 days treatment of Fucicort® Lipid cream, to Fucidin® cream followed by betamethasone (Lianbang Beisong®) cream, or Fucicort® Lipid cream vehicle, in subjects with clinically infected AD/eczema.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Diagnosis of AD/eczema as defined by Williams's criteria with clinical signs ofinfected AD/eczema on trunk and/or extremities such as fluid drainage, blisteredskin, white or yellow pus, severe itchiness and new burning sensation

  • A minimum score of 1 for each of the signs in the m-EASI score in at least one ofthe pre-defined body areas (trunk and/or extremities)

  • Subjects between 2 and 65 years of age

Exclusion

Exclusion Criteria:

  • History of concurrent diseases that could interfere with trial assessments or pose asafety concern

  • Subjects with other skin lesions, e.g. scarring, tattoos, or hyperpigmentation onthe treatment area that could interfere with assessments

  • Clinical findings such as severe heart, liver, kidney and lung deficiency, whichwill be impacted by the trial procedures at the investigator's discretion

  • Subjects who have received treatment with any non-marketed drug substance (i.e. anagent which has not yet been made available for clinical use following registration)within the last 4 weeks prior to randomisation at investigator's discretion

  • Use of prohibited medication, i.e.

  1. Systemic treatment with immunosuppressive or immunomodulating drugs(includingLeigongteng) or corticosteroids within 28 days prior to randomisation

  2. Use of topical or systemic antibiotics and anti-histamines within 14 days priorto randomisation

  3. Phototherapy (e.g. PUVA, UVA or UVB therapy) within 28 days prior torandomisation

  4. Topical treatment with immunomodulators (e.g. pimecrolimus, tacrolimus) within 14 days prior to randomisation

  5. Topical treatment with corticosteroids or any other topical treatment within 7days prior to randomisation

  6. Use of any non-prescribed systemic or cutaneous medication within 7 days priorto randomisation

  7. The use of analgesics at the discretion of the investigator is allowed beforeand during the trial

Study Design

Total Participants: 68
Treatment Group(s): 4
Primary Treatment: Fucicort® Lipid cream
Phase: 3
Study Start date:
July 31, 2018
Estimated Completion Date:
May 09, 2019

Connect with a study center

  • Beijing Children's Hospital, Capital Medical University

    Beijing, Beijing 100045
    China

    Site Not Available

  • Peking Union Medical College Hospital

    Beijing, Beijing 100730
    China

    Site Not Available

  • Guangdong General Hospital

    Guangzhou, Guangzhou 510080
    China

    Site Not Available

  • Tongji Hospital of Tongji Medical College of Huazhong Univ. of Science & Technology

    Wuhan, Hubei 430030
    China

    Site Not Available

  • Dermatology Hospital, China Academy of Medicine and Science

    Nanjing, Jiangsu 210042
    China

    Site Not Available

  • The First Affiliated Hospital of Soochow University

    Suzhou, Jiangsu 215006
    China

    Site Not Available

  • The First Hospital of Dalian Medical University

    Dalian, Liaoning 116011
    China

    Site Not Available

  • The Second Hospital of Dalian Medical University

    Dalian, Liaoning 116023
    China

    Site Not Available

  • The Chinese People's Liberation Army General Hospital Of Northern Theater

    Shenyang, Liaoning 110000
    China

    Site Not Available

  • The People's Hospital of Liaoning Province

    Shenyang, Liaoning 110016
    China

    Site Not Available

  • The Affiliated Hospital of Qingdao University

    Qingdao, Shandong 266000
    China

    Site Not Available

  • Children's Hospital of Shanghai

    Shanghai, Shanghai 200062
    China

    Site Not Available

  • Shanghai Huashan Hospital

    Shanghai, Shanghai 200040
    China

    Site Not Available

  • Tangdu Hospital

    Xi'an, Shanxi 710038
    China

    Site Not Available

  • Children's Hospital, Capital Institute of Pediatrics

    Beijing, 100020
    China

    Site Not Available

  • The First Affiliated Hospital of Chongqing Medical University

    Chongqing,
    China

    Site Not Available

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