An open label exploratory study of SVT-XCLEAR for mild-to-moderate atopic dermatitis in children and adults
Servatus Limited
30 participants
Jul 16, 2018
Interventional
Conditions
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).
Eligibility
Inclusion Criteria1
- 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.
Exclusion Criteria1
- 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
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Interventions
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.
Locations(1)
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ACTRN12618000998246