Severe Atopic DermatitisNCT03052348
Efficacy of Combining Topical Antibiotic/Steroid/Moisturizer Therapy Compared to Active Comparator in Atopic Dermatitis.
A study testing Polyethylene glycol hexadecyl ether & Betamethasone valerate cream 0.1% and Fusidic acid, polyethylene glycol hexadecyl ether & Betamethasone valerate cream 0.1% in people with Severe Atopic Dermatitis, run by Red Cross War Memorial Childrens Hospital at 3 sites in South Africa.
Trial summary
Atopic dermatitis (AD) is a chronic, relapsing inflammatory skin disease that occurs most commonly during early infancy and childhood. It is frequently associated with abnormalities in skin barrier function, allergen sensitization and recurrent skin infections. Read more about this study
- Who is it for?
- Ages 2 to 10 years
- Conditions the study is for
- Severe Atopic Dermatitis
- What is being tested?
- Polyethylene glycol hexadecyl ether & Betamethasone valerate cream 0.1% and Fusidic acid, polyethylene glycol hexadecyl ether & Betamethasone valerate cream 0.1%
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- 3 sitesSouth Africa
- Study dates
- 1 Nov 2017to 30 Aug 2018
- Phase
- Interventional
- 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 10 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Participants must have a parent/legally authorized representative, who is able to give informed consent and willing and able to comply with all the required study procedures. Assent is required from children who in the investigator's judgement, are capable of understanding the nature of the study.
- Participants must have have AD as defined by the UK Working Party Criteria
- Participants can be female or male, older than 2 years but younger than 10 years (up to their 10th birthday)
- Participants must not be on systemic antibiotics treatment at recruitment
- Participants must have a baseline SCORAD score of 50 or above (severe AD)
- Participants must be eligible for second line treatment agents for AD (systemic or photo therapy)
Who cannot join
- Participants must not be systemic agents (e.g. immunosuppressive) for AD
- Participants must not be younger than 2 years or over 10 years in age.
- Participants must not be using g bleach baths as a staphylococcus eradication measure at the time of enrollment,
- Participants must not have mild-moderate AD (SCORAD< 50)
- Participants must not be immune-compromised with AD
- Participants must not be on photo therapy for AD
- Participants must not be using wet wrap therapy for AD
Trial locations and contacts
3 sites in 1 country.
South Africa3 sites
Red Cross War Memorial Children's Hospital
Cape Town, Western Cape, 7700
King Edward Hospital
Durban, KwaZulu-Natal, 4013
Ncoza Dlova, MBCHB, 0312604530, Dlovan@ukzn.ac.za
Nelson Mandela Academic Hospital
Mthatha, Eastern Cape, 5099
Avumile Mankahla, MBCHB, 0836547566, Mankahla@gmail.com
Noluvuyo Qikani, MBCHB, 0833821188, lmvuyo@gmail.com
About this study
Official title: A Multicentre Study Evaluating the Efficacy of Combining Topical Antibiotic/Steroid/Moisturizer Therapy Compared to Standard of Care in the Treatment of Severe Atopic Dermatitis, a Phase II Randomized, Clinical Trial
Atopic dermatitis (AD) is a chronic, relapsing inflammatory skin disease that occurs most commonly during early infancy and childhood. It is frequently associated with abnormalities in skin barrier function, allergen sensitization and recurrent skin infections. AD is a major public health problem worldwide, with prevalence in children of 10-20% and 2-5% of the general population. The skin of AD patients is susceptible to colonization and infection with Staphylococcus aureus (SA )which contribute significantly to the severity of the clinical manifestations of eczema, triggering a vicious cycle.
Fusidic Acid (FA) cream is a topical antibiotic widely used in the treatment of skin and soft tissue infections and infected atopic dermatitis. However in recent years, the emergence of drug-resistant organisms, e.g. Methicillin- resistant Staphylococcus aureus (MRSA) has led to scrutiny of antibiotic use. Prolonged use of topical FA has been linked with emergence of FA-resistant Staphylococcus aureus (FRSA) . Fusidic acid is a natural antibiotic, extracted from cultures of Fusidium coccineum, which has a powerful antibacterial action. Topical use of Fusidic acid is fully in line with therapeutic strategies that recommend the use of an antibiotic with the narrowest activity spectrum to minimize the risk of resistance. In AD with infected lesions, combined treatment with antibiotic and steroid demonstrates greater efficacy over the use of steroid.
Read more
Trial Design: A three-center, double blind, randomized ,phase II , parallel group, efficacy trial.
Type of Intervention: A triple compounded cream containing a topical antibiotic , topical steroid and moisturizer.
Type of control: Active control containing a double compounded cream comprising a topical steroid and moisturizer .
Study population and Setting: A sample of 78 subjects will be recruited from Red Cross Children's Hospital , Nelson Mandela Academic Hospital and King Edward Hospital Estimated duration of trial: 12 months. Duration of participation: Each subject will participate in the trial for a maximum of 140 days.
Primary endpoint: reduction in SCORAD scores; frequency of clinical flares for AD and improvement in the quality of life at 140 days.
The benefit of this trial is that it provides a simple and effective approach to the management of atopic eczema.
- Conditions
- Severe Atopic Dermatitis
- Being tested
- Polyethylene glycol hexadecyl ether & Betamethasone valerate cream 0.1%, Fusidic acid, polyethylene glycol hexadecyl ether & Betamethasone valerate cream 0.1%
- Keywords
- Topical Antibiotics, Fusidic Acid, Atopic Dermatitis, Eczema
- Medical subject headings
- Dermatitis, Atopic, Eczema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Polyethylene glycol hexadecyl ether & Betamethasone valerate cream 0.1%Other
Also called Cetomacrogol 400g, Reg No PL 00240/0014., Lenovate cream, 15g, Reg No. 27/13.4.1/0493
Polyethylene glycol hexadecyl ether -Moisturizer. Betamethasone valerate cream 0.1% -Topical steroid
Fusidic acid, polyethylene glycol hexadecyl ether & Betamethasone valerate cream 0.1%Other
Also called Cetomacrogol 400g, Reg No PL 00240/0014., Lenovate cream, 15g, Reg No. 27/13.4.1/0493, Fusidic Acid (Fucidin cream), 15 g, Reg No. Q/20.1.6/128
Polyethylene glycol hexadecyl ether -Moisturizer. Betamethasone valerate cream 0.1% -Topical steroid Fusidic Acid - Topical Antibiotic
| Study group | Role | What they receive |
|---|---|---|
| Group R | Active comparator | Polyethylene glycol hexadecyl ether \& betamethasone valerate cream 0.1% . ( 4 applications per day for 14 days treatment to taper fortnightly) Receives: Other: Polyethylene glycol hexadecyl ether & Betamethasone valerate cream 0.1% |
| Group A | Experimental | Fusidic acid \& Polyethylene glycol hexadecyl ether,\& betamethasone valerate cream 0.1%). ( 4 applications per day for 14 days treatment to taper fortnightly) Receives: Other: Fusidic acid, polyethylene glycol hexadecyl ether & Betamethasone valerate cream 0.1% |
What is being measured
The primary outcome is the main question the study is designed to answer.
SCORAD scores
Reduction of SCORAD scores in the treatment group (A) of patients comparing with scores in the control group (R), at the end of the study with reference to baseline
Measured: 20 weeks
Secondary outcomes (3)
Infants Dermatitis' Quality of Life (IDQOL) index
Improvement in the Infants Dermatitis' Quality of Life (IDQOL) index in group (A) patients compared to that of the control group (R) at the end of the study compared to baseline
Measured: 20 weeks
Frequency of AD relapse episodes
Comparison of the frequency of AD relapse episodes in group (A) patients compared to the frequency of relapse episodes in control group (R) patients.
Measured: 20 Weeks
Time to AD Relapse
Comparison of the time to AD relapse episodes in group (A) patients compared to the time to relapse episodes in control group (R) patients.
Measured: 20 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2017
- Study start1 Nov 2017 (estimated)
- Primary completion30 Jul 2018 (estimated)
- Study completion30 Aug 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Severe Atopic DermatitisStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Fusidic acid, polyethylene glycol hexadecyl ether \& Betamethasone valerate cream 0.1%
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 78 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Red Cross War Memorial Childrens Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Carol Hlela, Red Cross War Memorial Childrens Hospital
- Investigators
- Dr Carol Hlela, MBCHB, Principal investigator, Red Cross Children's War Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03052348
- Sponsor's protocol ID
- RedCrossWMCH
- Status last verified
- Sep 2017
- First submitted
- 10 Feb 2017
- Last updated
- 25 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Sidbury R, Tom WL, Bergman JN, Cooper KD, Silverman RA, Berger TG, Chamlin SL, Cohen DE, Cordoro KM, Davis DM, Feldman SR, Hanifin JM, Krol A, Margolis DJ, Paller AS, Schwarzenberger K, Simpson EL, Williams HC, Elmets CA, Block J, Harrod CG, Smith Begolka W, Eichenfield LF. Guidelines of care for the management of atopic dermatitis: Section 4. Prevention of disease flares and use of adjunctive therapies and approaches. J Am Acad Dermatol. 2014 Dec;71(6):1218-33. doi: 10.1016/j.jaad.2014.08.038. Epub 2014 Sep 26.
PubMed 25264237Cardona ID, Cho SH, Leung DY. Role of bacterial superantigens in atopic dermatitis : implications for future therapeutic strategies. Am J Clin Dermatol. 2006;7(5):273-9. doi: 10.2165/00128071-200607050-00001.
PubMed 17007538Huang JT, Abrams M, Tlougan B, Rademaker A, Paller AS. Treatment of Staphylococcus aureus colonization in atopic dermatitis decreases disease severity. Pediatrics. 2009 May;123(5):e808-14. doi: 10.1542/peds.2008-2217.
PubMed 19403473Langan SM, Thomas KS, Williams HC. What is meant by a "flare" in atopic dermatitis? A systematic review and proposal. Arch Dermatol. 2006 Sep;142(9):1190-6. doi: 10.1001/archderm.142.9.1190.
PubMed 16983006Totte JE, van der Feltz WT, Hennekam M, van Belkum A, van Zuuren EJ, Pasmans SG. Prevalence and odds of Staphylococcus aureus carriage in atopic dermatitis: a systematic review and meta-analysis. Br J Dermatol. 2016 Oct;175(4):687-95. doi: 10.1111/bjd.14566. Epub 2016 Jul 5.
PubMed 26994362Nakamura Y, Oscherwitz J, Cease KB, Chan SM, Munoz-Planillo R, Hasegawa M, Villaruz AE, Cheung GY, McGavin MJ, Travers JB, Otto M, Inohara N, Nunez G. Staphylococcus delta-toxin induces allergic skin disease by activating mast cells. Nature. 2013 Nov 21;503(7476):397-401. doi: 10.1038/nature12655. Epub 2013 Oct 30.
PubMed 24172897
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicentre Study Evaluating the Efficacy of Combining Topical Antibiotic/Steroid/Moisturizer Therapy Compared to Standard of Care in the Treatment of Severe Atopic Dermatitis, a Phase II Randomized, Clinical Trial
- ClinicalTrials.gov ID
- NCT03052348
- Acronym / sponsor ID
- RedCrossWMCH
- Conditions
- Severe Atopic Dermatitis
- Keywords
- Topical Antibiotics, Fusidic Acid, Atopic Dermatitis, Eczema
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 78 participants (estimated)
- Lead sponsor
- Red Cross War Memorial Childrens HospitalUniversity, hospital or other
- Study start
- 1 Nov 2017 (estimated)
- Primary completion
- 30 Jul 2018 (estimated)
- Study completion
- 30 Aug 2018 (estimated)
- First posted
- 14 Feb 2017 (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.
Atopic dermatitis (AD) is a chronic, relapsing inflammatory skin disease that occurs most commonly during early infancy and childhood. It is frequently associated with abnormalities in skin barrier function, allergen sensitization and recurrent skin infections. AD is a major public health problem worldwide, with prevalence in children of 10-20% and 2-5% of the general population. The skin of AD patients is susceptible to colonization and infection with Staphylococcus aureus (SA )which contribute significantly to the severity of the clinical manifestations of eczema, triggering a vicious cycle.
Fusidic Acid (FA) cream is a topical antibiotic widely used in the treatment of skin and soft tissue infections and infected atopic dermatitis. However in recent years, the emergence of drug-resistant organisms, e.g. Methicillin- resistant Staphylococcus aureus (MRSA) has led to scrutiny of antibiotic use. Prolonged use of topical FA has been linked with emergence of FA-resistant Staphylococcus aureus (FRSA) . Fusidic acid is a natural antibiotic, extracted from cultures of Fusidium coccineum, which has a powerful antibacterial action. Topical use of Fusidic acid is fully in line with therapeutic strategies that recommend the use of an antibiotic with the narrowest activity spectrum to minimize the risk of resistance. In AD with infected lesions, combined treatment with antibiotic and steroid demonstrates greater efficacy over the use of steroid.
Trial Design: A three-center, double blind, randomized ,phase II , parallel group, efficacy trial.
Type of Intervention: A triple compounded cream containing a topical antibiotic , topical steroid and moisturizer.
Type of control: Active control containing a double compounded cream comprising a topical steroid and moisturizer .
Study population and Setting: A sample of 78 subjects will be recruited from Red Cross Children's Hospital , Nelson Mandela Academic Hospital and King Edward Hospital Estimated duration of trial: 12 months. Duration of participation: Each subject will participate in the trial for a maximum of 140 days.
Primary endpoint: reduction in SCORAD scores; frequency of clinical flares for AD and improvement in the quality of life at 140 days.
The benefit of this trial is that it provides a simple and effective approach to the management of atopic eczema.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Fusidic acid, polyethylene glycol hexadecyl ether \& Betamethasone valerate cream 0.1%
| Arm | Type | Receives |
|---|---|---|
| Group R | Active comparator | Other: Polyethylene glycol hexadecyl ether & Betamethasone valerate cream 0.1%Polyethylene glycol hexadecyl ether \& betamethasone valerate cream 0.1% . ( 4 applications per day for 14 days treatment to taper fortnightly) |
| Group A | Experimental | Other: Fusidic acid, polyethylene glycol hexadecyl ether & Betamethasone valerate cream 0.1%Fusidic acid \& Polyethylene glycol hexadecyl ether,\& betamethasone valerate cream 0.1%). ( 4 applications per day for 14 days treatment to taper fortnightly) |
Who may qualify
- Ages
- 2 to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Participants must have a parent/legally authorized representative, who is able to give informed consent and willing and able to comply with all the required study procedures. Assent is required from children who in the investigator's judgement, are capable of understanding the nature of the study.
- Participants must have have AD as defined by the UK Working Party Criteria
- Participants can be female or male, older than 2 years but younger than 10 years (up to their 10th birthday)
- Participants must not be on systemic antibiotics treatment at recruitment
- Participants must have a baseline SCORAD score of 50 or above (severe AD)
Key exclusion criteria (7 listed)
- Participants must not be systemic agents (e.g. immunosuppressive) for AD
- Participants must not be younger than 2 years or over 10 years in age.
- Participants must not be using g bleach baths as a staphylococcus eradication measure at the time of enrollment,
- Participants must not have mild-moderate AD (SCORAD< 50)
- Participants must not be immune-compromised with AD
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 |
|---|---|---|
| Polyethylene glycol hexadecyl ether & Betamethasone valerate cream 0.1%Also: Cetomacrogol 400g, Reg No PL 00240/0014., Lenovate cream, 15g, Reg No. 27/13.4.1/0493Polyethylene glycol hexadecyl ether -Moisturizer. Betamethasone valerate cream 0.1% -Topical steroid | Other | Group R |
| Fusidic acid, polyethylene glycol hexadecyl ether & Betamethasone valerate cream 0.1%Also: Cetomacrogol 400g, Reg No PL 00240/0014., Lenovate cream, 15g, Reg No. 27/13.4.1/0493, Fusidic Acid (Fucidin cream), 15 g, Reg No. Q/20.1.6/128Polyethylene glycol hexadecyl ether -Moisturizer. Betamethasone valerate cream 0.1% -Topical steroid Fusidic Acid - Topical Antibiotic | Other | Group A |
Primary outcome
SCORAD scores
Time frame: 20 weeks
Reduction of SCORAD scores in the treatment group (A) of patients comparing with scores in the control group (R), at the end of the study with reference to baseline
3 secondary outcomes
Infants Dermatitis' Quality of Life (IDQOL) index
Time frame: 20 weeks
Frequency of AD relapse episodes
Time frame: 20 Weeks
Time to AD Relapse
Time frame: 20 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2017.
- Background: PubMed 25264237Sidbury R, Tom WL, Bergman JN, Cooper KD, Silverman RA, Berger TG, Chamlin SL, Cohen DE, Cordoro KM, Davis DM, Feldman SR, Hanifin JM, Krol A, Margolis DJ, Paller AS, Schwarzenberger K, Simpson EL, Williams HC, Elmets CA, Block J, Harrod CG, Smith Begolka W, Eichenfield LF. Guidelines of care for the management of atopic dermatitis: Section 4. Prevention of disease flares and use of adjunctive therapies and approaches. J Am Acad Dermatol. 2014 Dec;71(6):1218-33. doi: 10.1016/j.jaad.2014.08.038. Epub 2014 Sep 26.
- Background: PubMed 17007538Cardona ID, Cho SH, Leung DY. Role of bacterial superantigens in atopic dermatitis : implications for future therapeutic strategies. Am J Clin Dermatol. 2006;7(5):273-9. doi: 10.2165/00128071-200607050-00001.
- Background: PubMed 19403473Huang JT, Abrams M, Tlougan B, Rademaker A, Paller AS. Treatment of Staphylococcus aureus colonization in atopic dermatitis decreases disease severity. Pediatrics. 2009 May;123(5):e808-14. doi: 10.1542/peds.2008-2217.
- Background: PubMed 16983006Langan SM, Thomas KS, Williams HC. What is meant by a "flare" in atopic dermatitis? A systematic review and proposal. Arch Dermatol. 2006 Sep;142(9):1190-6. doi: 10.1001/archderm.142.9.1190.
- Background: PubMed 26994362Totte JE, van der Feltz WT, Hennekam M, van Belkum A, van Zuuren EJ, Pasmans SG. Prevalence and odds of Staphylococcus aureus carriage in atopic dermatitis: a systematic review and meta-analysis. Br J Dermatol. 2016 Oct;175(4):687-95. doi: 10.1111/bjd.14566. Epub 2016 Jul 5.
- Background: PubMed 24172897Nakamura Y, Oscherwitz J, Cease KB, Chan SM, Munoz-Planillo R, Hasegawa M, Villaruz AE, Cheung GY, McGavin MJ, Travers JB, Otto M, Inohara N, Nunez G. Staphylococcus delta-toxin induces allergic skin disease by activating mast cells. Nature. 2013 Nov 21;503(7476):397-401. doi: 10.1038/nature12655. Epub 2013 Oct 30.
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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.
Dr Carol Hlela, MBCHB principal investigator
Red Cross Children's War Memorial Hospital
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Polyethylene glycol hexadecyl ether & Betamethasone valerate cream 0.1% and Fusidic acid, polyethylene glycol hexadecyl ether & Betamethasone valerate cream 0.1% in people with Severe Atopic Dermatitis, run by Red Cross War Memorial Childrens Hospital at 3 sites in South Africa.
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 6 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 25 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in South Africa. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dr Carol Hlela, MBCHB (0741724141, carol.hlela@uct.ac.za), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
SCORAD scores (time frame: 20 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03052348, which also lists 6 linked publications.
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 25 Sep 2017.