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A phase 2 randomized, double blind, placebo-controlled study to evaluate the safety and efficacy of topical AT-004 1% in the participants with acne vulgaris.

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2025-521510-25-00
Acronym
AT-004_2024
Enrollment
60
Registered
2025-11-07
Start date
2026-01-13
Completion date
Unknown
Last updated
2025-12-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acne vulgaris

Brief summary

Nature, incidence and severity of adverse events (AEs), along with changes in laboratory safety parameters, vital signs, physical examination, and body weight., Nature, incidence, and severity of skin reactions at the application site, Proportion of successes according to IGA score at week 8., Absolute change in number of inflammatory lesions at week 8., Absolute change in number of noninflammatory lesions at week 8.

Detailed description

Proportion of successes according to IGA score at weeks 4 and 12., Absolute change in number of inflammatory lesions at wees 4 and 12., Absolute change in number of noninflammatory lesions at weeks 4 and 12., Percent change in number of inflammatory lesions at weeks 4, 8 and 12., Percent change in number of noninflammatory lesions at weeks 4, 8 and 12, Establish pharmacokinetics of AT-004 in a subset of 5 participants., Change in Dermatology Life Quality Index (DLQI) score from baseline to weeks 4, 8 and 12., Reduction in DLQI of >4 points from baseline to week 8 and 12 among subjects with baseline DLQI >4

Interventions

DRUGMatched Placebo for IMP

Sponsors

Arctic Therapeutics hf.
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to 64 Years

Design outcomes

Primary

MeasureTime frame
Nature, incidence and severity of adverse events (AEs), along with changes in laboratory safety parameters, vital signs, physical examination, and body weight., Nature, incidence, and severity of skin reactions at the application site, Proportion of successes according to IGA score at week 8., Absolute change in number of inflammatory lesions at week 8., Absolute change in number of noninflammatory lesions at week 8.

Secondary

MeasureTime frame
Proportion of successes according to IGA score at weeks 4 and 12., Absolute change in number of inflammatory lesions at wees 4 and 12., Absolute change in number of noninflammatory lesions at weeks 4 and 12., Percent change in number of inflammatory lesions at weeks 4, 8 and 12., Percent change in number of noninflammatory lesions at weeks 4, 8 and 12, Establish pharmacokinetics of AT-004 in a subset of 5 participants., Change in Dermatology Life Quality Index (DLQI) score from baseline to weeks 4, 8 and 12., Reduction in DLQI of >4 points from baseline to week 8 and 12 among subjects with baseline DLQI >4

Countries

Denmark

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026