Status:
TERMINATED
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
Lead Sponsor:
LEO Pharma
Conditions:
Infected Atopic Dermatitis/Eczema
Eligibility:
All Genders
2-65 years
Phase:
PHASE3
Brief 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® Lip...
Eligibility Criteria
Inclusion
- Diagnosis of AD/eczema as defined by Williams's criteria with clinical signs of infected AD/eczema on trunk and/or extremities such as fluid drainage, blistered skin, 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 of the pre-defined body areas (trunk and/or extremities)
- Subjects between 2 and 65 years of age
Exclusion
- History of concurrent diseases that could interfere with trial assessments or pose a safety concern
- Subjects with other skin lesions, e.g. scarring, tattoos, or hyperpigmentation on the treatment area that could interfere with assessments
- Clinical findings such as severe heart, liver, kidney and lung deficiency, which will be impacted by the trial procedures at the investigator's discretion
- Subjects who have received treatment with any non-marketed drug substance (i.e. an agent 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.
- Systemic treatment with immunosuppressive or immunomodulating drugs(including Leigongteng) or corticosteroids within 28 days prior to randomisation
- Use of topical or systemic antibiotics and anti-histamines within 14 days prior to randomisation
- Phototherapy (e.g. PUVA, UVA or UVB therapy) within 28 days prior to randomisation
- Topical treatment with immunomodulators (e.g. pimecrolimus, tacrolimus) within 14 days prior to randomisation
- Topical treatment with corticosteroids or any other topical treatment within 7 days prior to randomisation
- Use of any non-prescribed systemic or cutaneous medication within 7 days prior to randomisation
- The use of analgesics at the discretion of the investigator is allowed before and during the trial
Key Trial Info
Start Date :
July 31 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 9 2019
Estimated Enrollment :
68 Patients enrolled
Trial Details
Trial ID
NCT03395132
Start Date
July 31 2018
End Date
May 9 2019
Last Update
February 24 2025
Active Locations (15)
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1
Beijing Children's Hospital, Capital Medical University
Beijing, Beijing Municipality, China, 100045
2
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China, 100730
3
Guangdong General Hospital
Guangzhou, Guangzhou, China, 510080
4
Tongji Hospital of Tongji Medical College of Huazhong Univ. of Science & Technology
Wuhan, Hubei, China, 430030