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Acne Vulgaris on the FacePhase 2NCT07774364

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

A Phase 2 study testing AT-004 in people with Acne Vulgaris on the Face, run by Arctic Therapeutics at 3 sites in Denmark.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 45 years
Conditions the study is for
Acne Vulgaris on the Face
What is being tested?
AT-004
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
63 participants
Where
3 sitesDenmark
Study dates
2 Feb 2026to 29 Jul 2026
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 45 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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)
  • At least [=>10 inflammatory lesions and =>15 noninflammatory lesions]) in face area at screening/baseline.
  • The individual is judged to be in sufficient medical health to be able to participate in the trial.
  • The individual has provided informed consent for participation in trial.
  • Female participant of child birth potential must use of at least an acceptably effective method of contraception (See contraception guide in Appendix 13.1.2) from enrolment up to at least 3 months after the study end. Postmenopausal status is defined as being amenorrheic for at least 1 year prior to screening. Sexually active men with a female partner of childbearing potential must agree to use condom from enrolment up to at least 3 months after the study end.
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  • Male participants must agree to maintain either a clean-shaven appearance or a neatly trimmed beard that does not interfere with study assessments from the screening to the end of treatment.
  • The individual is willing and is able to comply with all of the time commitments and procedural requirements of the protocol.
  • The individual will agree to have picture taken of their acne at baseline and follow up at 4 weeks, 8 weeks, and 12 weeks.

Who cannot join

  • The individual has clinically significant illness, mental or physical, that, in the opinion of the investigator, might confound the results of the trial, pose additional risk to the individual by their participation, or prevent/impede them from completing the trial.
  • More than 2 cysts or nodules at screening and baseline.
  • Acne conglobata, acne fulminans, or secondary acne.
  • Other disease that requires use of topical or systemic therapy that might interfere with the assessment of the study endpoints.
  • Use of oral retinoids in the past 6 months prior to the baseline visit.
  • Use of antibiotics in the past 4 weeks prior baseline visit.
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  • Use of topical retinoids in the past 4 weeks prior baseline visit.
  • Use of other topical acne treatments (such as benzoyl peroxide, topical antibiotics, clascoterone, salicylic acid, azelaic acid) in the past 2 weeks prior to baseline.
  • Use of corticosteroids (topical or systemic) in the past 4 weeks prior to baseline.
  • Use of OTC topical products containing hyaluronic acid, retinol, salicylic acid, Benzoyl peroxide (BPO) in the past week prior to baseline.
  • Prior acne procedure (including photodynamic therapy, laser, microdermabrasion, peelings, facials) in the past week prior to baseline.
  • New hormonal therapy or dose change to hormonal therapy within 12 weeks prior to baseline.
  • The individual has known sensitivity to donepezil.
  • Other concomitant treatments that might interfere with the evaluations.
  • The individual is pregnant or breastfeeding.
  • History of illicit drug use or abuse within the past six months prior to randomization.
  • The individual consumes excessive amounts of alcoholic beverages. (Excessive consumption defined as more than 21 units per week for men and 14 units per week for women)
  • There is any concern by the investigator regarding the individual's safety, compliance, or suitability with respect to their participation in the trial.

Trial locations and contacts

3 sites in 1 country.

Denmark3 sites

  • Sanos Gandrup Clinic

    Gandrup

  • Herlev Sanos Clinic

    Herlev

  • Sanos Vejle Clinic

    Vejle

Other trials in Denmark

About this study

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.

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.

Being tested
AT-004, Placebo
Keywords
Acne vulgaris
Medical subject headings
Acne Vulgaris

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AT-004Drug

    Participants receiving AT-004 topical application

  • PlaceboDrug

    Participants receiving matching placebo topical application

Study groups in NCT07774364
Study groupRoleWhat they receive
AT-004 treatmentExperimentalParticipants randomized to receive AT-004 according to protocol
Receives: Drug: AT-004
PlaceboPlacebo comparatorParticipants randomized to receive matching placebo according to the protocol
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 12 weeks

  2. Laboratory safety parameters

    Safety labs parameters not being outside of normal ranges and/or not clinically significant as assessed by the PI.

    Measured: 12 weeks

  3. Incidence of inflammatory and non-inflammatory lesions

    Incidence of inflammatory and non-inflammatory lesions at baseline and week 8.

    Measured: 12 weeks

Secondary outcomes (2)

  1. 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.

    Measured: 12 weeks

  2. 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"

    Measured: 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Aug 2026
  2. Study start2 Feb 2026
  3. Primary completion15 Jul 2026
  4. Study completion29 Jul 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
63 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07774364
Sponsor's protocol ID
AT-004_2024
Other IDs
2025-521510-25, 2025
Status last verified
Aug 2026
First submitted
2 Aug 2026
Last updated
19 Aug 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing AT-004 in people with Acne Vulgaris on the Face, run by Arctic Therapeutics at 3 sites in Denmark.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of Treatment-Emergent Adverse Events (time frame: 12 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07774364.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2026.

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