Safety and Efficacy of AT-004 in Patients with Acne Vulgaris

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Arctic Therapeutics hf.

Participant type

Patients

Age range

18-64 years

Gender

Male and Female

Therapeutic area

Diseases [C] - Skin and Connective Tissue Diseases [C17]

Trial duration

13 Jan 2026 → ongoing

Decision date (initial)

2025-11-07

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy, Safety

To evaluate safety and tolerability of AT-004 administered topically in adults with acne vulgaris
To evaluate efficacy in terms of Investigator Global Assessment (IGA) at week 8.
To evaluate efficacy in terms of the number of inflammatory and non-inflammatory lesions at week 8.

Secondary objectives 4

1. To evaluate efficacy in terms of Investigator Global Assessment (IGA) at week 4 and 12.
2. To evaluate efficacy in terms of the number of inflammatory and non-inflammatory lesions at weeks 4 and 12.
3. To evaluate the health-related quality of life of AT-004 administered topically in individuals with acne vulgaris
4. Characterize pharmacokinetic parameters of AT-004 when administered topically to adults with acne vulgaris

Conditions and MedDRA coding

Acne vulgaris

Regulatory references

Scientific advice from competent authorities

Food And Drug Administration

Plan to share IPD

No

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 9

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 informed consent for participation in trial
6. 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.
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 18

1. 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.
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 corticosteroids (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.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 5

1. Nature, incidence and severity of adverse events (AEs), along with changes in laboratory safety parameters, vital signs, physical examination, and body weight.
2. Nature, incidence, and severity of skin reactions at the application site
3. Proportion of successes according to IGA score at week 8.
4. Absolute change in number of inflammatory lesions at week 8.
5. Absolute change in number of noninflammatory lesions at week 8.

Secondary endpoints 8

1. Proportion of successes according to IGA score at weeks 4 and 12.
2. Absolute change in number of inflammatory lesions at wees 4 and 12.
3. Absolute change in number of noninflammatory lesions at weeks 4 and 12.
4. Percent change in number of inflammatory lesions at weeks 4, 8 and 12.
5. Percent change in number of noninflammatory lesions at weeks 4, 8 and 12
6. Establish pharmacokinetics of AT-004 in a subset of 5 participants.
7. Change in Dermatology Life Quality Index (DLQI) score from baseline to weeks 4, 8 and 12.
8. Reduction in DLQI of >4 points from baseline to week 8 and 12 among subjects with baseline DLQI >4

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Placebo 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Arctic Therapeutics hf.

Sponsor organisation

Arctic Therapeutics hf.

Address

Bjargargata 1

City

Reykjavik

Postcode

102

Country

Iceland

Scientific contact point

Organisation

Arctic Therapeutics hf.

Contact name

Public contact point

Public contact point

Organisation

Arctic Therapeutics hf.

Contact name

Public contact point

Third parties 5

Locations

1 EU/EEA country · 3 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 7 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

2 submissions — initial application plus substantial / non-substantial modifications