Can a new gel outsmart stubborn acne?
NCT ID NCT07774364
First seen Aug 19, 2026 · Last updated Aug 20, 2026 · Updated 1 time
Summary
This phase 2 trial is testing whether a topical gel called AT-004 can safely reduce acne lesions on the face. Adults aged 18 to 45 with mild-to-severe facial acne will apply the gel or a placebo daily for several weeks. Researchers will track changes in lesion counts and skin condition, as well as any side effects, to see if the treatment shows promise.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- AT-004 1% topical gel
- What this could lead to
- If successful, this could lead to a new topical treatment option for moderate-to-severe facial acne, potentially reducing lesion counts and improving skin appearance.
- What could go wrong
- This is an early-phase trial with a small number of participants, so results may not hold up in larger studies. The treatment may cause skin irritation or other side effects, and its effectiveness is not yet proven.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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63 people
The number who actually took part.
- Started
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Feb 2026
- Finished
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Jul 2026
- Lead sponsor
-
A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 45 years
- Sex
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Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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 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: 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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Herlev Sanos Clinic
Herlev, Denmark
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Sanos Gandrup Clinic
Gandrup, Denmark
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Sanos Vejle Clinic
Vejle, Denmark
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