Trials Sponsors Conditions Drugs Pricing

Conditions

Acne vulgaris Acne Vulgaris on the Face

Keywords

Acne vulgaris

Outcome Measures

Primary Outcomes (3)

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.
12 weeks
Laboratory safety parameters
Safety labs parameters not being outside of normal ranges and/or not clinically significant as assessed by the PI.
12 weeks
Incidence of inflammatory and non-inflammatory lesions
Incidence of inflammatory and non-inflammatory lesions at baseline and week 8.
12 weeks

Secondary Outcomes (2)

Evaluation of efficacy in terms of Investigator Global Assessment (IGA)
12 weeks
Health-related quality of life after AT-004 administered topically in individuals with acne vulgaris
12 weeks

Study Arms (2)

AT-004 treatment

EXPERIMENTAL

Participants randomized to receive AT-004 according to protocol

Drug: AT-004

Placebo

PLACEBO COMPARATOR

Participants randomized to receive matching placebo according to the protocol

Drug: Placebo

Interventions

AT-004Drug

Participants receiving AT-004 topical application

AT-004 treatment

PlaceboDrug

Participants receiving matching placebo topical application

Placebo

Eligibility Criteria

Age18 Years - 45 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64)

You may qualify if:

The individual is between 18 years and 45 years old.
At Screening visit and Visit 1/Baseline has mild, moderate or severe facial acne (defined as an Investigator Global Assessment \[IGA\] score of 2 or more on the face)

Sponsors & Collaborators

Arctic Therapeutics hf.
Industrylead
Blueskin AS
Industrycollaborator
Arctic Therapeutics

Study Sites (3)

Sanos Gandrup Clinic

Gandrup, Denmark

Herlev Sanos Clinic

Herlev, Denmark

Sanos Vejle Clinic

Vejle, Denmark

MeSH Terms

Conditions

Acne Vulgaris

Condition Hierarchy (Ancestors)

Acneiform EruptionsSkin DiseasesSkin and Connective Tissue DiseasesSebaceous Gland Diseases

Enrollment

63 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 2
Allocation: RANDOMIZED
Masking: QUADRUPLE
Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

August 2, 2026

First Posted

August 19, 2026

Study Start

February 2, 2026

Actual (reported)

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

Primary Completion

Study Completion

First Submitted

First Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (3)

Secondary Outcomes (2)

Study Arms (2)

AT-004 treatment

Placebo

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (3)

Related Links

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source records

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

Primary Completion

Study Completion

First Submitted

First Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (3)

Secondary Outcomes (2)

Study Arms (2)

AT-004 treatment

Placebo

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (3)

Related Links

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source records

Locations