ClinicalTrials.gg
CompletedNCT07774364Updated Aug 19, 2026

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

A Phase 2 interventional study of AT-004 and Placebo in Acne Vulgaris on the Face, sponsored by Arctic Therapeutics. Completed at 3 sites in Denmark. Open to participants aged 18 Years to 45 Years. Per ClinicalTrials.gov, last updated 2026-08-19.

Sponsored by Arctic Therapeutics · Phase 2, Interventional, and Treatment

From the registry’s dates

  • Registered 6 months after the study started (first participant enrolled Feb 2026, registered Aug 2026).
Phase
Phase 2
Study type
Interventional
Enrollment
63
Allocation
Randomized
Ages
18 Years to 45 Years
Sex
All
01

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.

02

Conditions studied

  • Acne Vulgaris on the Face

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Keywords

  • Acne vulgaris
03

In context

Acne Vulgaris

790 studies on the registry are indexed under Acne Vulgaris; 93 are open to participants now.

This study's enrollment of 63 is close to the median of 70 across 672 interventional studies indexed under Acne Vulgaris.

Browse Acne Vulgaris studies →

Lead sponsor

Arctic Therapeutics is the lead sponsor of 3 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. The individual is between 18 years and 45 years old.
  2. 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)
  3. At least [=>10 inflammatory lesions and =>15 noninflammatory lesions]) in face area at screening/baseline.
  4. The individual is judged to be in sufficient medical health to be able to participate in the trial.
  5. The individual has provided for participation in trial.
  6. Female participant of child birth potential must use of at least an acceptably effective method of (See contraception guide in Appendix 13.1.2) from enrolment up to at least 3 months after the study end. status is defined as being amenorrheic for at least 1 year prior to screening. Sexually active men with a female partner of must agree to use condom from enrolment up to at least 3 months after the study end.
  7. 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.
  8. The individual is willing and is able to comply with all of the time commitments and procedural requirements of the protocol.
  9. The individual will agree to have picture taken of their acne at baseline and follow up at 4 weeks, 8 weeks, and 12 weeks.

Exclusion criteria

Exclusion Criteria:

  1. The individual has 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.
  2. More than 2 cysts or nodules at screening and baseline.
  3. Acne conglobata, acne fulminans, or secondary acne.
  4. Other disease that requires use of topical or systemic therapy that might interfere with the assessment of the study endpoints.
  5. Use of oral retinoids in the past 6 months prior to the baseline visit.
  6. Use of antibiotics in the past 4 weeks prior baseline visit.
  7. Use of topical retinoids in the past 4 weeks prior baseline visit.
  8. 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.
  9. Use of (topical or systemic) in the past 4 weeks prior to baseline.
  10. Use of OTC topical products containing hyaluronic acid, retinol, salicylic acid, Benzoyl peroxide (BPO) in the past week prior to baseline.
  11. Prior acne procedure (including photodynamic therapy, laser, microdermabrasion, peelings, facials) in the past week prior to baseline.
  12. New hormonal therapy or dose change to hormonal therapy within 12 weeks prior to baseline.
  13. The individual has known sensitivity to donepezil.
  14. Other concomitant treatments that might interfere with the evaluations.
  15. The individual is pregnant or breastfeeding.
  16. History of illicit drug use or abuse within the past six months prior to randomization.
  17. 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)
  18. There is any concern by the investigator regarding the individual's safety, compliance, or suitability with respect to their participation in the trial.
Terms in these criteria, in plain language(6)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

Postmenopausal

Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
63 participants (actual)

Study arms

  • Experimental
    AT-004 treatment

    Participants randomized to receive AT-004 according to protocol

    Drug: AT-004

  • Placebo comparator
    Placebo

    Participants randomized to receive matching placebo according to the protocol

    Drug: Placebo

Interventions

  • DrugAT-004

    Participants receiving AT-004 topical application

  • DrugPlacebo

    Participants receiving matching placebo topical application

06

What researchers measure

Primary outcomes

  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.

    Time frame: 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.

    Time frame: 12 weeks

  3. Incidence of inflammatory and non-inflammatory lesions

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

    Time frame: 12 weeks

Secondary outcomes

  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.

    Time frame: 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"

    Time frame: 12 weeks

07

Study locations

3 sites
  • Sanos Gandrup Clinic
    Gandrup, Denmark
  • Herlev Sanos Clinic
    Herlev, Denmark
  • Sanos Vejle Clinic
    Vejle, Denmark
08

References and documents

Related links

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Feb 2026 to primary completion in Jul 2026, 5 months.

Of 29 industry-sponsored phase 2 interventional studies under Acne Vulgaris, half reached primary completion within 9 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 15. This study's 5 months is below that.

Counting every sponsor, half of 37 studies reached it within 9 months; a quarter within 6 and three quarters within 15.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 2, 2026
First posted
Aug 19, 2026
StartActual
Feb 2, 2026
Primary completionActual
Jul 15, 2026
CompletionActual
Jul 29, 2026
Last update
Aug 19, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 19, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07774364
Collaborators
Blueskin AS
Responsible party
Sponsor
First posted
Aug 19, 2026
Start date
Feb 2, 2026
Primary completion
Jul 15, 2026
Completion
Jul 29, 2026
Last update
Aug 19, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.

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