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

LEO Pharma

Status and phase: Terminated; Phase 3

Conditions: Infected Atopic Dermatitis/Eczema

Treatments: Drug: Fucicort® Lipid cream; Drug: Fucicort® Lipid cream vehicle; Drug: Fucidin® cream; Drug: betamethasone (Lianbang Beisong®) cream

Study type: Interventional

Funder types: Industry

Identifiers

NCT03395132

FCF-38

Details and patient eligibility

About

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.

Enrollment: 68 patients

Sex: All

Ages: 2 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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 criteria

• 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.

  1. Systemic treatment with immunosuppressive or immunomodulating drugs(including Leigongteng) or corticosteroids within 28 days prior to randomisation
  2. Use of topical or systemic antibiotics and anti-histamines within 14 days prior to randomisation
  3. Phototherapy (e.g. PUVA, UVA or UVB therapy) within 28 days prior to randomisation
  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 7 days prior to randomisation
  6. Use of any non-prescribed systemic or cutaneous medication within 7 days prior to randomisation
  7. The use of analgesics at the discretion of the investigator is allowed before and during the trial

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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68 participants in 3 patient groups, including a placebo group

Fucicort® Lipid cream

Experimental group

Description:

Fucicort® Lipid cream is a combination of the antibiotic fusidic acid (20 mg/g) and the corticosteroid betamethasone (1 mg/g (as 17-valerate)). Twice daily for two weeks.

Treatment:

Drug: Fucicort® Lipid cream

Fucidin cream +betamethasone cream

Active Comparator group

Description:

The combination treatment with Fucidin® cream followed by betamethasone (Lianbang Beisong®) cream. Twice daily for two weeks.

Treatment:

Drug: betamethasone (Lianbang Beisong®) cream

Drug: Fucidin® cream

Vehicle cream

Placebo Comparator group

Description:

The vehicle cream, also named as Fucicort® Lipid cream vehicle, is the identical cream of Fucicort Lipid cream but without the active ingredient. Twice daily for two weeks.

Treatment:

Drug: Fucicort® Lipid cream vehicle