Topical Hidracare Solution in Participants with Mild to Moderate Hidradenitis Suppurativa

Phase 1

Completed

• Conditions: Hidradenitis suppurativa; Skin - Dermatological conditions

• Registration Number: ACTRN12619001734156
• Lead Sponsor: Aerotech Australia Pty Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-12-09
• Study Completion: 2022-02-01
• Last Update Posted: 16 May 2022

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 19

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified