NL-OMON50746
Completed
Phase 2
A randomized, subject and investigator blinded, placebo-controlled, multicenter study in parallel groups to assess the efficacy and safety of LYS006 in patients with moderate to severe inflammatory acne - CLYS006X2201
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Acne
- Sponsor
- ovartis
- Enrollment
- 8
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •The patients eligible for inclusion in this study must fulfill all of the
- •following criteria:
- •1\. Written informed consent must be obtained before any assessment is performed.
- •2\. Male and female subjects aged 18 to 45 years of age inclusive, and otherwise
- •in good health as determined by medical history, physical examination, and
- •vital signs. Electrocardiograms and laboratory tests should be consistent with
- •normal values at screening.
- •3\. Body weight between 50 and 120 kg, both inclusive, at screening.
- •4\. Patients with papulo\-pustular acne vulgaris (inflammatory acne):
- •\- presenting at baseline with :
Exclusion Criteria
- •The patients fulfilling any of the following criteria are not eligible for
- •inclusion in this study:
- •1\. Previous treatment with investigational drugs at the time of screening, or
- •within 4 weeks or 5 half\-lives of baseline, whichever is longer; or more as
- •required by local regulations.
- •2\. Previous treatment with any topical anti\-acne therapy:
- •\* prescription treatment within 2 weeks prior to baseline
- •\* OTC within 1 week prior to baseline
- •The use of medicated anti\-acne creams, medicated cleansers or medicated soaps
- •is prohibited.
Outcomes
Primary Outcomes
Not specified
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