Authorised Therapeutic exploratory (Phase II) Acne vulgaris

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

EU CTIS ID: 2025-521510-25-00

What this study is testing

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.

  • Therapeutic exploratory (Phase II)

A plain-language read of the study's public EU CTIS listing. The study team confirms the details.

Who can take part

You may be able to join 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)
  • 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.

You likely can't join if

  • 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.
  • 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
See the full eligibility criteria
Who can 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.
  • 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
What rules you out
  • 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.
  • 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.
  • 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.
  • 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

The study team makes the final eligibility decision.

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling all sexes, 18-64 years. The study team makes the final eligibility decision.

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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.