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Safety and Efficacy of Topical AT-004 1% in Participants With Acne Vulgaris (AV)

NCT07774364 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 63

Last updated 2026-08-19

No results posted yet for this study

Summary

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.

Conditions

  • Acne Vulgaris on the Face

Interventions

DRUG

AT-004

Participants receiving AT-004 topical application

DRUG

Placebo

Participants receiving matching placebo topical application

Sponsors & Collaborators

  • Blueskin AS

    collaborator INDUSTRY

  • Arctic Therapeutics

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-02-02
Primary Completion
2026-07-15
Completion
2026-07-29

Countries

  • Denmark

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07774364 on ClinicalTrials.gov