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Trial registered on ANZCTR


Registration number
ACTRN12619001734156p
Ethics application status
Not yet submitted
Date submitted
28/11/2019
Date registered
9/12/2019
Date last updated
9/12/2019
Date data sharing statement initially provided
9/12/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Topical Hidracare Solution in Participants with Mild to Moderate Hidradenitis Suppurativa
Scientific title
An Open-Label Study to Evaluate the Safety and Efficacy of Topical Hidracare Solution in Participants with Mild to Moderate Hidradenitis Suppurativa (as defined by Hurley Stage I or II) Over an 8-Week Treatment Period.
Secondary ID [1] 299848 0
Protocol number: AERHS-001
Sponsor Aerotech Australia Pty Ltd
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hidradenitis suppurativa 315242 0
Condition category
Condition code
Skin 313549 313549 0 0
Dermatological conditions

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Hidracare powder is an unregistered product, consisting of two well-known mineral salts (magnesium chloride and magnesium sulfate) and two antioxidant, anti-inflammatory compounds (dimethyl sulfone (MSM) and alpha lipoic acid (ALA)) in a base of sodium bicarbonate, with xanthum gum added as a thickener. The composition of the active ingredients is:
Magnesium sulfate heptahydrate (51.02% w/w)
Magnesium chloride hexahydrate (26.18% w/w)
Dimethyl sulfone (15.71% w/w)
Alpha lipoic acid (0.52% w/w)

A few drops of Hidracare solution is to be applied topically twice a day to hidradenitis suppurativa lesions over 8 weeks. The areas treated should be moist, not wet.

Adherence to the investigational product will be determined by participant diary entries and the number of used and unused Hidracare powder sachets returned. As the amount of Hidracare topical solution used will vary depending on the number of lesions and how freely the solution is applied by each individual, any unused solution returned will suitable to determine compliance.
Intervention code [1] 316105 0
Treatment: Drugs
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 322001 0
Safety measured by incidence of treatment emergent Adverse Events (AEs) and Serious Adverse Events (SAEs).

Possible application site reactions, such as increased redness, dryness, burning, pain or irritation.

Daily participant diary entries, and validated questionnaires and clinical assessments at study visits will be used to assess safety outcomes during the study.

Questionnaires and assessments to be used are:
- Hospital Anxiety and Depression Scale (HADS)
- Visual Analogue Scale (VAS)
- Dermatology Life Quality Index (DLQI)
- Modified Sartorius Score
-HS Physician Global Assessment




Timepoint [1] 322001 0
Post commencement of intervention and up to 2 weeks after last treatment.
Primary outcome [2] 322003 0
Percentage of participants with improvement in Physician Global Assessment (PGA).
Timepoint [2] 322003 0
Post commencement of intervention at days 28, 56 and 70.
Secondary outcome [1] 376974 0
Change from baseline in participant’s modified Sartorius Score.
Timepoint [1] 376974 0
Post commencement of intervention at days 28, 56 and 70.
Secondary outcome [2] 376976 0
Change from baseline in participant’s total abscess and inflammatory nodule count, known as AN count (this is a composite outcome).
Timepoint [2] 376976 0
Post commencement of intervention at days 28, 56 and 70.
Secondary outcome [3] 376977 0
Percentage of participants achieving clinical response as measured by HS Clinical Response.
Timepoint [3] 376977 0
Post commencement of intervention at days 28, 56 and 70.
Secondary outcome [4] 376978 0
Proportion of participants who experience an improvement in the Dermatology Life Quality Index from baseline.
Timepoint [4] 376978 0
Post commencement of intervention at days 28, 56 and 70.
Secondary outcome [5] 376979 0
Mean change from baseline in the Visual Analogue Scale pain scores.
Timepoint [5] 376979 0
Post commencement of intervention at days 28, 56 and 70.
Secondary outcome [6] 376980 0
Percentage of participants who experience an improvement from baseline in their Hospital Anxiety and Depression Scale.
Timepoint [6] 376980 0
Post commencement of intervention at days 28, 56 and 70.

Eligibility
Key inclusion criteria
1. Males and females 18 years or older.
2. Diagnosis by dermatologist of hidradenitis suppurativa, as defined by Hurley Stage I or II.
3. A minimum of one lesion in at least one distinct anatomical location.
4. Participant must read and understand the informed consent form, and must have signed it prior to any study-related procedures being performed.
5. Willingness and ability to comply with all scheduled study visits and study procedures.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. The use of any HS treatment (excluding study product) during the study and during the 4 weeks prior to study entry. Participants may remain on other medications provided they have been on a stable dose for at least 4 weeks prior to study entry and that the dose remains stable throughout the study.
2. Participants are not to use any topical products on the HS area/s, such as washes, deodorant or make-up during the study or during the 2 weeks prior to screening/baseline visit.
3. Participant does not agree to refrain from draining fluid from the affected HS area/s for the duration of the study.
4. Women who are pregnant or lactating. All women of childbearing potential must complete a urine pregnancy test at Screening (Visit 1) and the result must be negative to be eligible for enrolment.
5. Female participants of childbearing potential who are sexually active and are not willing to use a highly effective method of contraception. Female participants should refrain from getting pregnant for the duration of the study.
6. Any participant who does not agree to apply the product to the affected HS area/s twice daily for the duration of the treatment period.
7. Participants who have any disease or condition that is likely to interfere with the evaluation of the study product, such as skin cancers or any other co-morbidity deemed by the investigator to be not suitable for this study.
8. Participant has a known allergy to any of the ingredients used in Hidracare.
9. Participation in any investigational study within 8 weeks of screening visit.

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
Single group
Other design features
Phase
Phase 0
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis
Descriptive statistics will be used to summarise continuous variables in tabular format, while categorical variables will be summaries using count and percent of study group. All tabulated data will be summarised by study visit and include change from baseline, as appropriate.

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)
VIC
Recruitment hospital [1] 15179 0
Sinclair Dermatology - East Melbourne
Recruitment postcode(s) [1] 28489 0
3002 - East Melbourne

Funding & Sponsors
Funding source category [1] 304305 0
Commercial sector/Industry
Name [1] 304305 0
Aerotech Australia Pty Ltd
Address [1] 304305 0
PO Box 36313 Winnellie Northern Territory 0821
Australia
Country [1] 304305 0
Australia
Funding source category [2] 304416 0
Government body
Name [2] 304416 0
Department of Trade, Business and Innovation Northern Territory Government of Australia
Address [2] 304416 0
PO Box 9800, Alice Springs Northern Territory 0871
Australia
Country [2] 304416 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Aerotech Australia Pty Ltd
Address
PO Box 36313 Winnellie Northern Territory 0821
Australia
Country
Australia
Secondary sponsor category [1] 304550 0
None
Name [1] 304550 0
Address [1] 304550 0
Country [1] 304550 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 304758 0
Bellberry Limited
Ethics committee address [1] 304758 0
Bellberry Limited
123 Glen Osmond Road, Eastwood, South Australia, 5063
Australia
Ethics committee country [1] 304758 0
Australia
Date submitted for ethics approval [1] 304758 0
11/12/2019
Approval date [1] 304758 0
Ethics approval number [1] 304758 0

Summary
Brief summary
Hidracare, a topical solution, is a proposed treatment for mild to moderate hidradenitis suppurativa (HS), and this proof of concept study is designed to assess the safety and efficacy of Hidracare.

It is expected this topical solution will be beneficial in reducing the number of lesions in participants with mild HS. As Hidracare is not yet approved for marketing or evaluated through human clinical trials, no clinical experience of this specific investigational product is available. However, a literature review provides data demonstrating the safety and efficacy of the four active ingredients in Hidracare (magnesium sulfate heptahydrate, magnesium chloride hexahydrate, alpha lipoic acid and dimethyl sulfone).

This is an open-label study in which a total of up to 20 participants will be enrolled in the study and will receive active treatment, applied to all HS lesions twice daily for 8-weeks.









Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 98110 0
Prof Rodney Sinclair
Address 98110 0
Sinclair Dermatology
Level 2, 2 Wellington Parade
East Melbourne VIC 3002
Australia
Country 98110 0
Australia
Phone 98110 0
+61 3 96542426
Fax 98110 0
Email 98110 0
Rodney.sinclair@sinclairdermatology.com.au
Contact person for public queries
Name 98111 0
Dr Helena Dickenson
Address 98111 0
Regulatory Concepts Pty Ltd
Unit 9, 7 Anella Ave
Castle Hill NSW 2154
Australia
Country 98111 0
Australia
Phone 98111 0
+61 2 9846 1911
Fax 98111 0
Email 98111 0
helenad@regcon.com.au
Contact person for scientific queries
Name 98112 0
Dr Helena Dickenson
Address 98112 0
Regulatory Concepts Pty Ltd
Unit 9, 7 Anella Ave
Castle Hill NSW 2154
Australia
Country 98112 0
Australia
Phone 98112 0
+61 2 9846 1911
Fax 98112 0
Email 98112 0
helenad@regcon.com.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
What supporting documents are/will be available?
No other documents available
Summary results
No Results