Infected Atopic Dermatitis/EczemaPhase 3NCT03395132
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
A Phase 3 study testing Fucicort® Lipid cream, Fucidin® cream and betamethasone (Lianbang Beisong®) cream in people with Infected Atopic Dermatitis/Eczema, run by LEO Pharma at 15 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 2 to 65 years
- Conditions the study is for
- Infected Atopic Dermatitis/Eczema
- What is being tested?
- Fucicort® Lipid cream, Fucidin® cream and betamethasone (Lianbang Beisong®) cream
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 68 participants
- Where
- 15 sitesChina
- Study dates
- 31 Jul 2018to 9 May 2019
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
China15 sites
Beijing Children's Hospital, Capital Medical University
Beijing, Beijing Municipality, 100045
Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100730
Children's Hospital, Capital Institute of Pediatrics
Beijing, 100020
The First Hospital of Dalian Medical University
Dalian, Liaoning, 116011
The Second Hospital of Dalian Medical University
Dalian, Liaoning, 116023
Guangdong General Hospital
Guangzhou, Guangzhou, 510080
Dermatology Hospital, China Academy of Medicine and Science
Nanjing, Jiangsu, 210042
The Affiliated Hospital of Qingdao University
Qingdao, Shandong, 266000
Shanghai Huashan Hospital
Shanghai, Shanghai Municipality, 200040
Children's Hospital of Shanghai
Shanghai, Shanghai Municipality, 200062
The Chinese People's Liberation Army General Hospital Of Northern Theater
Shenyang, Liaoning, 110000
The People's Hospital of Liaoning Province
Shenyang, Liaoning, 110016
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, 215006
Tongji Hospital of Tongji Medical College of Huazhong Univ. of Science & Technology
Wuhan, Hubei, 430030
Tangdu Hospital
Xi'an, Shan'xi, 710038
About this study
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.
- Conditions
- Infected Atopic Dermatitis/Eczema
- Being tested
- Fucicort® Lipid cream, Fucidin® cream, Fucicort® Lipid cream vehicle, betamethasone (Lianbang Beisong®) cream
- Medical subject headings
- Eczema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fucicort® Lipid creamDrug
The active ingredient of Fucicort® Lipid cream are Fusidic acid and betamethasone. The pack size of Fucicort® Lipid cream is 15g.
Fucidin® creamDrug
The active ingredient of Fucidin® cream is Fusidic acid. The pack size of Fucidin® cream is 15g.
Fucicort® Lipid cream vehicleDrug
The active ingredient of Fucicort® Lipid cream vehicle is the identical cream of Fucicort® Lipid cream but without the active ingredient. The pack size of Fucicort® Lipid cream vehicle is 15g.
betamethasone (Lianbang Beisong®) creamDrug
The active ingredient of betamethasone (Lianbang Beisong®) cream is Betamethasone hydrate. The pack size of betamethasone (Lianbang Beisong®) cream is 15g.
| Study group | Role | What they receive |
|---|---|---|
| Fucicort® Lipid cream | Experimental | 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. Receives: Drug: Fucicort® Lipid cream |
| Fucidin cream +betamethasone cream | Active comparator | The combination treatment with Fucidin® cream followed by betamethasone (Lianbang Beisong®) cream. Twice daily for two weeks. Receives: Drug: Fucidin® cream; Drug: betamethasone (Lianbang Beisong®) cream |
| Vehicle cream | Placebo comparator | 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. Receives: Drug: Fucicort® Lipid cream vehicle |
What is being measured
The primary outcome is the main question the study is designed to answer.
The percentage change in modified Eczema Area and Severity Index (m-EASI) on trunk and extremities at Day 15
The percentage change in modified Eczema Area and Severity Index (m-EASI) on trunk and extremities from baseline to Day 15. The m-EASI is a composite score evaluating the severity of 4 clinical signs (erythema, oedema/induration/papulation, excoriation, and lichenification) and the extent of the disease on each of 3 body regions (upper limbs, trunk, and lower limbs) by use of standard scales. The maximum total score is 64.8, with higher values indicating more severe and/or more extensive condition.
Measured: from baseline to Day 15
Secondary outcomes (4)
Investigator's Global Assessment (IGA) at Day 15
The IGA of disease severity on the body (trunk and extremities, excluding the hands, head, and neck) will be assessed based on a visual evaluation by use of definitions of severity ranging from 0 (clear) to 5 (very severe).
Measured: at Day 15
Controlled disease according to IGA
Controlled disease according to IGA at Day 15, defined as subjects having at least 'moderate' disease at baseline achieving 'clear' or 'almost clear' disease severity or subjects having 'mild' disease at baseline achieving 'clear' according to IGA.
Measured: at Day 15
Proportion of patients with successful bacteriological response
Proportion of patients with successful bacteriological response, defined as pathogens present on target lesion at baseline and either: a) no pathogen present on target lesion at Day 15 ('confirmed eradication') or b) no swab taken at Day 15 as no lesion was evident ('presumptive eradication').
Measured: at Day 15
Adverse event (AE)/serious adverse event (SAE) frequency
Adverse event (AE)/serious adverse event (SAE) frequency by preferred term. Ongoing (serious or non-serious) AE with a possible, probable, or non-assessable relationship to the IMP at the last visit in the treatment phase. The investigator should follow up on the outcome for 14±2 days or until the final outcome is determined. This follow-up visit can be made either as a phone call or as a regular visit according to the investigator's discretion.
Measured: baseline to Day 15 and 14±2 days follow up or until the final outcome is determined
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2018
- Study start31 Jul 2018
- Primary completion9 May 2019
- Study completion9 May 2019
Why it stopped: Due to business strategic reasons, LEO Pharma has decided to close down the FCF-38 trial.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infected Atopic Dermatitis/EczemaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- LEO Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Study Director, Study director, LEO Pharma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03395132
- Sponsor's protocol ID
- FCF-38
- Status last verified
- May 2019
- First submitted
- 3 Jan 2018
- Last updated
- 24 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT03395132
- Acronym / sponsor ID
- FCF-38
- Conditions
- Infected Atopic Dermatitis/Eczema
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Due to business strategic reasons, LEO Pharma has decided to close down the FCF-38 trial.
- Enrolment
- 68 participants (actual)
- Lead sponsor
- LEO PharmaIndustry (pharma, biotech, devices)
- Study start
- 31 Jul 2018 (actual)
- Primary completion
- 9 May 2019 (actual)
- Study completion
- 9 May 2019 (actual)
- First posted
- 10 Jan 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Fucicort® Lipid cream | Experimental | Drug: Fucicort® Lipid creamFucicort® 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. |
| Fucidin cream +betamethasone cream | Active comparator | Drug: Fucidin® cream, Drug: betamethasone (Lianbang Beisong®) creamThe combination treatment with Fucidin® cream followed by betamethasone (Lianbang Beisong®) cream. Twice daily for two weeks. |
| Vehicle cream | Placebo comparator | Drug: Fucicort® Lipid cream vehicleThe 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. |
Who may qualify
- Ages
- 2 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fucicort® Lipid creamThe active ingredient of Fucicort® Lipid cream are Fusidic acid and betamethasone. The pack size of Fucicort® Lipid cream is 15g. | Drug | Fucicort® Lipid cream |
| Fucidin® creamThe active ingredient of Fucidin® cream is Fusidic acid. The pack size of Fucidin® cream is 15g. | Drug | Fucidin cream +betamethasone cream |
| Fucicort® Lipid cream vehicleThe active ingredient of Fucicort® Lipid cream vehicle is the identical cream of Fucicort® Lipid cream but without the active ingredient. The pack size of Fucicort® Lipid cream vehicle is 15g. | Drug | Vehicle cream |
| betamethasone (Lianbang Beisong®) creamThe active ingredient of betamethasone (Lianbang Beisong®) cream is Betamethasone hydrate. The pack size of betamethasone (Lianbang Beisong®) cream is 15g. | Drug | Fucidin cream +betamethasone cream |
Primary outcome
The percentage change in modified Eczema Area and Severity Index (m-EASI) on trunk and extremities at Day 15
Time frame: from baseline to Day 15
The percentage change in modified Eczema Area and Severity Index (m-EASI) on trunk and extremities from baseline to Day 15. The m-EASI is a composite score evaluating the severity of 4 clinical signs (erythema, oedema/induration/papulation, excoriation, and lichenification) and the extent of the disease on each of 3 body regions (upper limbs, trunk, and lower limbs) by use of standard scales. The maximum total score is 64.8, with higher values indicating more severe and/or more extensive condition.
4 secondary outcomes
Investigator's Global Assessment (IGA) at Day 15
Time frame: at Day 15
Controlled disease according to IGA
Time frame: at Day 15
Proportion of patients with successful bacteriological response
Time frame: at Day 15
Adverse event (AE)/serious adverse event (SAE) frequency
Time frame: baseline to Day 15 and 14±2 days follow up or until the final outcome is determined
Results and safety
The study was stopped early (reason given: Due to business strategic reasons, LEO Pharma has decided to close down the FCF-38 trial.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Study Director study director
LEO Pharma
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Fucicort® Lipid cream, Fucidin® cream and betamethasone (Lianbang Beisong®) cream in people with Infected Atopic Dermatitis/Eczema, run by LEO Pharma at 15 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 24 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Due to business strategic reasons, LEO Pharma has decided to close down the FCF-38 trial.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The percentage change in modified Eczema Area and Severity Index (m-EASI) on trunk and extremities at Day 15 (time frame: from baseline to Day 15). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Feb 2025.