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Trial registered on ANZCTR


Registration number
ACTRN12624000276550
Ethics application status
Approved
Date submitted
24/01/2024
Date registered
18/03/2024
Date last updated
5/10/2024
Date data sharing statement initially provided
18/03/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Topical use of Eucalypt sap resin for damaged skin
Scientific title
Safety and efficacy of Eucalypt sap resin for inflammatory skin conditions and wound care in adults – An exploratory case series
Secondary ID [1] 311406 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Inflammatory skin conditions 332677 0
Wound care 332847 0
Condition category
Condition code
Injuries and Accidents 329383 329383 0 0
Other injuries and accidents
Alternative and Complementary Medicine 329384 329384 0 0
Herbal remedies
Skin 329385 329385 0 0
Other skin conditions

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Arm A - Eucalypt extract (C5-2024) in inert gel formulation

The treatment will be individualised as appropriate for each case and documented as individual case studies. The gel will be applied topically to affected skin area at a dose of 1mL per cm2. For all wound presentations, the product will be applied by a wound care nurse in a medical clinic, in accordance with standard wound management guidelines appropriate for the type of wound, i.e. application and re-dressing every 7 days or as required. For all other conditions, the product will be applied by the participant themselves in their home environment. Adherence and overall usage of test product will be checked by monitoring of remaining gel amounts.
Intervention code [1] 327842 0
Treatment: Drugs
Comparator / control treatment
Arm B - Eucalypt extract (E5-2024) in inert gel formulation

The treatment will be individualised as appropriate for each case and documented as individual case studies. The gel will be applied topically to affected skin area at a dose of 1mL per cm2. For all wound presentations, the product will be applied by a wound care nurse in a medical clinic, in accordance with standard wound management guidelines appropriate for the type of wound, i.e. application and re-dressing every 7 days or as required. For all other conditions, the product will be applied by the participant themselves in their home environment. Adherence and overall usage of test product will be checked by monitoring of remaining gel amounts.
Control group
Active

Outcomes
Primary outcome [1] 337205 0
Evaluation of reported adverse events
Timepoint [1] 337205 0
Assessment timepoints will be evaluated periodically throughout, with intervals dependent on individual skin presentation. This may be daily until healed for acute conditions such as sunburn or every week for longer term management of skin inflammation conditions such as acne. As this is a case series data collection study, this will be variable between conditions.
Primary outcome [2] 337206 0
Time to heal of damaged and inflamed skin conditions
Timepoint [2] 337206 0
Assessment timepoints will be evaluated periodically throughout, with intervals dependent on individual skin presentation. This may be daily until healed for acute conditions such as sunburn or every week for longer term management of skin inflammation conditions such as acne or chronic wounds. As this is a case series data collection study, this will be variable between conditions.
Primary outcome [3] 337389 0
Infection development at treatment sites in wounds
Timepoint [3] 337389 0
At designated review timepoints specific to wound type and standard wound management guidelines, For example, acute wounds may be assessed daily and chronic wounds may be assessed weekly over a 2-month period.
Secondary outcome [1] 431068 0
Potential effectiveness of topical application for anti-microbial prevention and treatment
Timepoint [1] 431068 0
Assessment timepoints will be evaluated periodically throughout, with intervals dependent on individual skin presentation. This may be daily until healed for acute conditions such as sunburn or every week for longer term management of skin inflammation conditions such as acne. As this is a case series data collection study, this will be variable between conditions.
Secondary outcome [2] 431069 0
Clinical improvement of wound parameters
Timepoint [2] 431069 0
Assessment timepoints will be evaluated periodically throughout, with intervals dependent on individual wound type and severity. As this is a case series data collection study, this will be variable between individuals, i.e. acute wounds may be assessed within 3 days and chronic wounds may be assessed weekly over a 2 month period.
Secondary outcome [3] 431070 0
Patient subjective assessment of effectiveness
Timepoint [3] 431070 0
This will only be assessed once participant has completed the study. The timeframe is variable depending on skin condition.

Eligibility
Key inclusion criteria
Adult males and females
Presence of inflammatory skin condition or wound
Minimum age
18 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Pregnant, planning pregnancy or breastfeeding
- Any clinically relevant abnormal findings which, in the opinion of the Investigators may put the participant at risk of adverse events due to participation in clinical trial.
- Use of any topical or oral anti-microbial, anti-fungal, anti-acne, or steroid medicated treatments in the previous 3 days

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
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/04/2024
Actual
24/04/2024
Date of last participant enrolment
Anticipated
1/11/2025
Actual
Date of last data collection
Anticipated
15/12/2025
Actual
Sample size
Target
60
Accrual to date
6
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD

Funding & Sponsors
Funding source category [1] 315665 0
Commercial sector/Industry
Name [1] 315665 0
Integria Healthcare (Australia) Pty Ltd.
Country [1] 315665 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Integria Healthcare (Australia) Pty Ltd.
Address
Building 5, Freeway Office Park, 2728 Logan rd, Eight Mile Plains, QLD, 4113
Country
Australia
Secondary sponsor category [1] 317767 0
None
Name [1] 317767 0
Address [1] 317767 0
Country [1] 317767 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 314544 0
National Institute of Integrative Medicine NIIM Human Research Ethics Committee
Ethics committee address [1] 314544 0
Ethics committee country [1] 314544 0
Australia
Date submitted for ethics approval [1] 314544 0
05/09/2023
Approval date [1] 314544 0
09/11/2023
Ethics approval number [1] 314544 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 131962 0
Dr Elizabeth Steels
Address 131962 0
Building 5, Freeway Office Park, 2728, Logan Rd, Eight Mile Plains QLD 4113
Country 131962 0
Australia
Phone 131962 0
+61 428983280
Fax 131962 0
Email 131962 0
elizabeth.steels@integria.com
Contact person for public queries
Name 131963 0
Elizabeth Steels
Address 131963 0
Building 5, Freeway Office Park, 2728, Logan Rd, Eight Mile Plains QLD 4113
Country 131963 0
Australia
Phone 131963 0
+61 428983280
Fax 131963 0
Email 131963 0
elizabeth.steels@integria.com
Contact person for scientific queries
Name 131964 0
Elizabeth Steels
Address 131964 0
Building 5, Freeway Office Park, 2728, Logan Rd, Eight Mile Plains QLD 4113
Country 131964 0
Australia
Phone 131964 0
+61 428983280
Fax 131964 0
Email 131964 0
elizabeth.steels@integria.com

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
This study is commercial in confidence


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.