Efficacy of Combining Topical Antibiotic/Steroid/Moisturizer Therapy Compared to Active Comparator in Atopic Dermatitis.

September 22, 2017 updated by: Dr Carol Hlela, Red Cross War Memorial Childrens Hospital

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.

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 Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

78

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • South Africa
    • Eastern Cape
      • Mthatha, Eastern Cape, South Africa, 5099
        • Nelson Mandela Academic Hospital
        • Contact:
        • Contact:
    • KwaZulu Natal
      • Durban, KwaZulu Natal, South Africa, 4013
        • King Edward Hospital
        • Contact:
    • Western Cape
      • Cape Town, Western Cape, South Africa, 7700
        • Red Cross War Memorial Children's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years to 10 years (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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)

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Group R
Polyethylene glycol hexadecyl ether & betamethasone valerate cream 0.1% . ( 4 applications per day for 14 days treatment to taper fortnightly)
Other: Polyethylene glycol hexadecyl ether & Betamethasone valerate cream 0.1%
Polyethylene glycol hexadecyl ether -Moisturizer. Betamethasone valerate cream 0.1% -Topical steroid
Other Names:
  • Cetomacrogol 400g, Reg No PL 00240/0014.
  • Lenovate cream, 15g, Reg No. 27/13.4.1/0493
EXPERIMENTAL: Group A
Fusidic acid & Polyethylene glycol hexadecyl ether,& betamethasone valerate cream 0.1%). ( 4 applications per day for 14 days treatment to taper fortnightly)
Other: Fusidic acid, polyethylene glycol hexadecyl ether & Betamethasone valerate cream 0.1%
Polyethylene glycol hexadecyl ether -Moisturizer. Betamethasone valerate cream 0.1% -Topical steroid Fusidic Acid - Topical Antibiotic
Other Names:
  • 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
20 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Infants Dermatitis' Quality of Life (IDQOL) index
Time Frame: 20 weeks
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
20 weeks
Frequency of AD relapse episodes
Time Frame: 20 Weeks
Comparison of the frequency of AD relapse episodes in group (A) patients compared to the frequency of relapse episodes in control group (R) patients.
20 Weeks
Time to AD Relapse
Time Frame: 20 weeks
Comparison of the time to AD relapse episodes in group (A) patients compared to the time to relapse episodes in control group (R) patients.
20 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Red Cross War Memorial Childrens Hospital

Investigators

  • Principal Investigator: Dr Carol Hlela, MBCHB, Red Cross Children's War Memorial Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

November 1, 2017

Primary Completion (ANTICIPATED)

July 30, 2018

Study Completion (ANTICIPATED)

August 30, 2018

Study Registration Dates

First Submitted

February 10, 2017

First Submitted That Met QC Criteria

February 13, 2017

First Posted (ACTUAL)

February 14, 2017

Study Record Updates

Last Update Posted (ACTUAL)

September 25, 2017

Last Update Submitted That Met QC Criteria

September 22, 2017

Last Verified

September 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RedCrossWMCH

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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