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COMPLETED
NCT07774364
PHASE2

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

Sponsor: Arctic Therapeutics

View on ClinicalTrials.gov

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.

Official title: A Phase 2 Randomized, Double Blind, Placebo-controlled Study to Evaluate the Safety and Efficacy of Topical AT-004 1% in Participants With Acne Vulgaris.

Key Details

Gender

All

Age Range

18 Years - 45 Years

Study Type

INTERVENTIONAL

Enrollment

63

Start Date

2026-02-02

Completion Date

2026-07-29

Last Updated

2026-08-19

Healthy Volunteers

No

Interventions

DRUG

AT-004

Participants receiving AT-004 topical application

DRUG

Placebo

Participants receiving matching placebo topical application

Locations (3)

Sanos Gandrup Clinic

Gandrup, Denmark

Herlev Sanos Clinic

Herlev, Denmark

Sanos Vejle Clinic

Vejle, Denmark