None listed
Conditions
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.
Interventions
Hidracare powder (H122-2) 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.
Hidracare powder is combined with bottled water to create Hidracare solution. A few drops of Hidracare solution is to be applied topically twice a day to hidradenitis suppurativa lesions over 8 weeks. The areas treated shoul
Hidracare powder (H122-2) 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. Hidracare powder is combined with bottled water to create Hidracare solution. 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.
Sponsors
Aerotech Australia Pty Ltd
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
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.
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.
Outcome results
None listed