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Trial registered on ANZCTR


Registration number
ACTRN12618000998246p
Ethics application status
Submitted, not yet approved
Date submitted
11/06/2018
Date registered
14/06/2018
Date last updated
21/06/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
An open label exploratory study of SVT-XCLEAR for mild-to-moderate atopic dermatitis in children and adults
Scientific title
An open label exploratory study of SVT-XCLEAR for mild-to-moderate atopic dermatitis in children and adults
Secondary ID [1] 295126 0
None
Universal Trial Number (UTN)
U1111-1215-3844
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Atopic Dermatitis 308225 0
Staphylococcus infection 308282 0
Condition category
Condition code
Skin 307255 307255 0 0
Dermatological conditions
Infection 307321 307321 0 0
Studies of infection and infectious agents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A combination of three bacterial strains (SVT9, SVT23 and SVT26) at a concentration of 2.5 billion CFU/mL per bacterial strain in a carrier of sterile saline solution.

The study medication is topically applied (sprayed) to a specified active dermatitis lesion at a dose of 2 x 0.2 mL (0.4 mL per dose; 3 billion CFU/0.4 mL) twice per day (morning and evening) after showering, leaving at least 6 hours between applications. The moistened skin is to dry naturally and not rubbed. The spray cap provides a precise 0.2 mL dose per spray.
The duration of administration is for 21 days.

Monitoring participant adherence in applying the 2 sprays twice per day will be done via the participant recording each time they apply the spray in a paper diary that will be provided. Diaries will be provided at baseline, Day 7 and Day 14 providing 3 diaries in total and the investigator will collect the diaries at each visit.
Intervention code [1] 301500 0
Treatment: Drugs
Comparator / control treatment
The study involves a single group only. The participant will treat one active dermatological lesion with the treatment medication and a contralateral lesion i.e. crease in opposite elbow or knee will be used as a control lesion in which the participant can only apply their normal daily moisturiser to it. They will not be allowed to apply any topical medications to their control contralateral lesion.
Control group
Active

Outcomes
Primary outcome [1] 306243 0
1. Target lesion local objective SCORing Atopic Dermatitis (SCORAD) that will assess the clinical signs and symptoms of the target lesion and control lesion and to monitor changes in disease severity.
Timepoint [1] 306243 0
Baseline, Day 7, Day 14 and Day 21
Primary outcome [2] 306244 0
Sampling and quantification of Staphylococcus aureus colonisation on the target and contralateral lesions. Sampling will be conducted via the swab method and identification and quantification will be done at Sullivan & Nicolaides Pathology.
Timepoint [2] 306244 0
Baseline and Day 21
Secondary outcome [1] 347971 0
A composite secondary outcome is the cutaneous tolerability of treatment that will be assessed by the investigator at each visit. Tolerability will be based on signs of erythema, induration or papulation, oozing or crusting, excoriation, lichenification and pruritus in the target lesion. All signs classified according to intensity (0=none, 1=mild, 2=moderate and 3=severe)
Timepoint [1] 347971 0
Day 7, Day 14 and Day 21

Eligibility
Key inclusion criteria
Male and female participants aged 6 years and older diagnosed (as per Rajka-Hanifin criteria) with AD of mild-to-moderate severity at baseline (Investigator Global Assessment of 2 or 3) who exhibit at least two AD lesions of a dimension greater than or equal to 20 cm2. The locations of AD lesions need to allow for accurate sampling. The lesional skin is defined as an active lesion of AD: an erythematous plaque with or without oozing, vesiculation, crusting, excoriations, or erosions but with no overt sign of infection, located within the antecubital or popliteal fossae, or other region typical of AD. Women of child bearing age must have a negative pregnancy test at baseline. Participants and guardians will need to be capable of providing informed consent and comply with the study instructions.
Minimum age
6 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Severe fungal infection or other skin disease that could affect AD diagnosis; uncontrolled or serious disease, or any condition that could interfere with data interpretation or put the participant at significant risk; recent use of other investigational drugs or procedures; participants who cannot adhere to refraining from using topical steroids, antibiotics or antiseptics on the two treated lesions only (treatment and control) for the study duration (topical medications can be used elsewhere on the body if required); participants who cannot adhere to refraining from consuming oral steroids or antibiotics. Also those who cannot abstain from the intake of probiotic supplements and foods from induction (Day 0) into the study and for the duration of the study will be excluded

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Participants will act as their own control in which two lesions will be chosen by the investigator and one lesion will designated the 'active treatment' lesion and the other designated the 'control' lesion. The participants are not permitted to apply any topical medications such as steroids and antibiotics to either of the two lesions, and only SVT-XCLEAR can be applied to the active treatment lesion and only the participants daily moisturiser can be applied to the control lesion if required..
Phase
Phase 0
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 11120 0
University of Sunshine Coast Health Clinics - Sippy Downs
Recruitment postcode(s) [1] 22935 0
4558 - Maroochydore
Recruitment postcode(s) [2] 22936 0
4556 - Sippy Downs

Funding & Sponsors
Funding source category [1] 299718 0
Commercial sector/Industry
Name [1] 299718 0
Servatus Limited
Address [1] 299718 0
University of the Sunshine Coast
Innovation Centre
90 Sippy Downs Dr
Sippy Downs. QLD 4556
Country [1] 299718 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Servatus Limited
Address
University of the Sunshine Coast
Innovation Centre
90 Sippy Downs Dr
Sippy Downs, QLD 4556
Country
Australia
Secondary sponsor category [1] 299092 0
None
Name [1] 299092 0
Address [1] 299092 0
Country [1] 299092 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 300606 0
Bellberry Limited
Ethics committee address [1] 300606 0
129 Glen Osmond Road
Eastwood
South Australia, 5063
Ethics committee country [1] 300606 0
Australia
Date submitted for ethics approval [1] 300606 0
08/06/2018
Approval date [1] 300606 0
Ethics approval number [1] 300606 0

Summary
Brief summary
Study Design: Single centre, open-label, single arm exploratory study

Study drugs: A combination of three bacterial strains (SVT9, SVT23 and SVT26) at a concentration of 2.5 billion CFU/mL per bacterial strain in a carrier of sterile saline solution.

Dose and duration: The study medication is topically applied (sprayed) to a specified active dermatitis lesion at a dose of 2 x 0.2 mL (0.4 mL per dose; 3 billion CFU/0.4 mL) twice per day (morning and evening) after showering, leaving at least 6 hours between applications. The moistened skin is to dry naturally and not rubbed. The spray cap provides a precise 0.2 mL dose per spray. The duration of administration is for 21 days.

Objectives of the Study: Feasibility of methods and procedures, recruitment potential, increase clinical experience of study medication; evaluate surrogate marker data in a small patient cohort to assess if it will be therapeutically effective and safe for further larger studies.

Study Endpoints: Primary outcome measures will include assessment of treatment efficacy using 1. Target lesion local objective SCORing Atopic Dermatitis (SCORAD) that will assess the clinical signs and symptoms of the target lesion and control lesion and to monitor changes in disease severity; 2. Sampling and quantification of S. aureus colonisation on the target and contralateral lesion.

Secondary outcome measures: 1. Cutaneous tolerability of treatment based on signs of redness, dryness, crusting, weeping, peeling, thickening and itching of the target lesion. All signs classified according to intensity (0 = none, 1 = mild, 2 = moderate and 3 = severe).
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 84198 0
Dr Susan Thackwray
Address 84198 0
University of Sunshine Coast
Clinical Trials Centre
90 Sippy Downs Dr
Sippy Downs, QLD 4556
Country 84198 0
Australia
Phone 84198 0
+61 7 5456 5265
Fax 84198 0
Email 84198 0
sthackwr@usc.edu.au
Contact person for public queries
Name 84199 0
Dr Samantha Coulson
Address 84199 0
University of the Sunshine Coast
Innovations Centre
90 Sippy Downs Dr
Sippy Downs, QLD 4556
Country 84199 0
Australia
Phone 84199 0
+61 7 5430 2216
Fax 84199 0
Email 84199 0
samantha.coulson@servatus.com.au
Contact person for scientific queries
Name 84200 0
Dr Samantha Coulson
Address 84200 0
Servatus Ltd
Innovations Centre, University of the Sunshine Coast
90 Sippy DOwns Dr
Sippy Downs, QLD 4556
Country 84200 0
Australia
Phone 84200 0
+61 7 5430 2216
Fax 84200 0
Email 84200 0
samantha.coulson@servatus.com.au

No information has been provided regarding IPD availability
Summary results
No Results