Double blinded, randomized, placebo-controlled trial to determine the safety and efficacy of topical AT-004 therapy in participants with acne vulgaris, including assessment of reduction in the number of acne lesions and IGA. A PK sub-study will be performed in a subset of participants. Participants with moderate to severe acne vulgaris, aged 18 to 45 years, who are likely to meet inclusion and none of the exclusion criteria will be invited for a screening visit. The study include a screening period, treatment phase with the baseline visit at day 1 and a follow -up visits at week 4, 8 and week 12. All participants will be followed by a follow-up call within 4 weeks from last visit. A total number of 60 participants will be enrolled.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
63
Participants receiving AT-004 topical application
Participants receiving matching placebo topical application
Sanos Gandrup Clinic
Gandrup, Denmark
Herlev Sanos Clinic
Herlev, Denmark
Sanos Vejle Clinic
Vejle, Denmark
Incidence of Treatment-Emergent Adverse Events
Incidence of Treatment-Emergent Adverse Events in response to AT-004 administered topically in subjects with Acne vulgaris. Assessment of the amount of mild and severe adverse events related to the treatment.
Time frame: 12 weeks
Laboratory safety parameters
Safety labs parameters not being outside of normal ranges and/or not clinically significant as assessed by the PI.
Time frame: 12 weeks
Incidence of inflammatory and non-inflammatory lesions
Incidence of inflammatory and non-inflammatory lesions at baseline and week 8.
Time frame: 12 weeks
Evaluation of efficacy in terms of Investigator Global Assessment (IGA)
Absolute change in number of inflammatory and non-inflammatory lesions at weeks 4 and 12 terms of Investigator Global Assessment (IGA). With a score from 0 - 4. Higher score means a severe outcome.
Time frame: 12 weeks
Health-related quality of life after AT-004 administered topically in individuals with acne vulgaris
Change in Dermatology Life Quality Index (DLQI) score from baseline to weeks 4, 8 and 12. This is a 4 Point Likert scale, ranging from "Very much" to "Not at all"
Time frame: 12 weeks
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