Status:
COMPLETED
LTX-109 as Treatment for Hidradenitis Suppurativa
Lead Sponsor:
Pharma Holdings AS
Collaborating Sponsors:
University Hospital of North Norway
Conditions:
Hidradenitis Suppurativa
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
An Open label Phase II//proof of concept-study to demonstrate if percutaneous application of LTX-109 in a gel vehicle is a safe treatment of Hidradenitis suppurativa and to identify clinical response ...
Detailed Description
It is unclear whether bacterial colonization in hidradenitis suppurativa/acne inversa (HS) comprises a primary cause, triggering factor or secondary phenomenon of the disease pathogenesis. Studies imp...
Eligibility Criteria
Inclusion
- Patients with active hidradenitis in the stage I-II according to Hurley's classification.
- Patients are referred to a dermatology out-patient clinic or patients already in an established treatment program, where there is indication for new or different treatment, or surgical intervention.
- Patients must have typical affection of the disease of either axillae, groins, and/or perigenital/perianal area
- Signed informed consent and expected cooperation of the patients for the treatment and follow up must be obtained and documented according to international guidelines, and national/local regulations.
- For women in fertile age: Concents to use highly effective contraception until the end of the study
Exclusion
- Patients in need of emergency medical or surgical treatment of hidradenitis
- Subjects must not have used the following HS treatments within the specified timeframe prior to Baseline Visit:
- Systemic therapy for HS, including but not limited to corticosteroids, antibiotics, dapsone or retinoids within 4 weeks
- Targeted biologic treatments (refer to within 5 half-lives \[if known\]) or within 12 weeks, whichever is longer.
- Topical treatments with antibiotics, including but not limited to clindamycin within 4 weeks
- Patients with hidradenitis affecting larger areas (\>5 palm units)
- Patient does not agree to be registered in the national quality register for HS
- Pregnant or lactating women
- Any reason why, in the opinion of the investigator, the patient should not participate
Key Trial Info
Start Date :
March 5 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2021
Estimated Enrollment :
11 Patients enrolled
Trial Details
Trial ID
NCT04756336
Start Date
March 5 2021
End Date
July 1 2021
Last Update
August 30 2021
Active Locations (1)
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1
University Hospital of North Norway
Tromsø, Norway, 9038