Donepezil hydrochloride for Acne vulgaris

Inclusion criteria

• {"criterion_text":"- The individual is between 18 years and 45 years old\n- 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)\n- At least [=>10 inflammatory lesions and =>15 noninflammatory lesions]) in face area at screening /baseline\n- The individual is judged to be in sufficient medical health to be able to participate in the trial.\n- The individual has provided informed consent for participation in trial\n- 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.\n- 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.\n- The individual is willing and is able to comply with all of the time commitments and procedural requirements of the protocol\n- 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

• {"criterion_text":"- 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.\n- Use of OTC topical products containing hyaluronic acid, retinol, salicylic acid, Benzoyl peroxide (BPO) in the past week prior to baseline\n- Prior acne procedure (including photodynamic therapy, laser, microdermabrasion, peelings, facials) in the past week prior to baseline.\n- New hormonal therapy or dose change to hormonal therapy within 12 weeks prior to baseline\n- The individual has known sensitivity to donepezil.\n- Other concomitant treatments that might interfere with the evaluations\n- The individual is pregnant or breastfeeding\n- History of illicit drug use or abuse within the past six months prior to randomization\n- 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)\n- There is any concern by the investigator regarding the individual’s safety, compliance, or suitability with respect to their participation in the trial.\n- More than 2 cysts or nodules at screening and baseline\n- Acne conglobata, acne fulminans, or secondary acne\n- Other disease that requires use of topical or systemic therapy that might interfere with the assessment of the study endpoints\n- Use of oral retinoids in the past 6 months prior to the baseline visit\n- Use of antibiotics in the past 4 weeks prior baseline visit.\n- Use of topical retinoids in the past 4 weeks prior baseline visit.\n- 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\n- Use of corticosteroids (topical or systemic) in the past 4 weeks prior to baseline"}

Primary endpoints

• {"endpoint_text":"- Nature, incidence and severity of adverse events (AEs), along with changes in laboratory safety parameters, vital signs, physical examination, and body weight.","definition_or_measurement_approach":"Safety will be assessed by recording nature, incidence and severity of AEs and changes in laboratory safety parameters, vital signs, physical examination findings and body weight (standard AE reporting and lab/vital sign assessments)."}
• {"endpoint_text":"- Nature, incidence, and severity of skin reactions at the application site","definition_or_measurement_approach":"Assessment of local skin reactions at the application site by investigator-reported nature, incidence and severity (dermatologic reaction assessments)."}
• {"endpoint_text":"- Proportion of successes according to IGA score at week 8.","definition_or_measurement_approach":"Investigator Global Assessment (IGA) at week 8; proportion achieving predefined 'success' per IGA (IGA scoring defined in protocol)."}
• {"endpoint_text":"- Absolute change in number of inflammatory lesions at week 8.","definition_or_measurement_approach":"Lesion counts: absolute change from baseline in number of inflammatory lesions at week 8 (investigator lesion counts)."}
• {"endpoint_text":"- Absolute change in number of noninflammatory lesions at week 8.","definition_or_measurement_approach":"Lesion counts: absolute change from baseline in number of noninflammatory lesions at week 8 (investigator lesion counts)."}

Secondary endpoints

• {"endpoint_text":"- Proportion of successes according to IGA score at weeks 4 and 12.","definition_or_measurement_approach":"IGA assessments at weeks 4 and 12; proportion classified as success at those timepoints."}
• {"endpoint_text":"- Absolute change in number of inflammatory lesions at wees 4 and 12.","definition_or_measurement_approach":"Absolute change from baseline in inflammatory lesion counts at weeks 4 and 12."}
• {"endpoint_text":"- Absolute change in number of noninflammatory lesions at weeks 4 and 12.","definition_or_measurement_approach":"Absolute change from baseline in noninflammatory lesion counts at weeks 4 and 12."}
• {"endpoint_text":"- Percent change in number of inflammatory lesions at weeks 4, 8 and 12.","definition_or_measurement_approach":"Percent change from baseline in inflammatory lesion counts at weeks 4, 8 and 12."}
• {"endpoint_text":"- Percent change in number of noninflammatory lesions at weeks 4, 8 and 12","definition_or_measurement_approach":"Percent change from baseline in noninflammatory lesion counts at weeks 4, 8 and 12."}
• {"endpoint_text":"- Establish pharmacokinetics of AT-004 in a subset of 5 participants.","definition_or_measurement_approach":"Pharmacokinetic sampling and analysis in a subset of 5 participants to characterize PK parameters of topical AT-004."}
• {"endpoint_text":"- Change in Dermatology Life Quality Index (DLQI) score from baseline to weeks 4, 8 and 12.","definition_or_measurement_approach":"DLQI questionnaire administered at baseline and weeks 4, 8 and 12; change from baseline measured."}
• {"endpoint_text":"- Reduction in DLQI of >4 points from baseline to week 8 and 12 among subjects with baseline DLQI >4","definition_or_measurement_approach":"Proportion of subjects with baseline DLQI >4 achieving a reduction >4 points at weeks 8 and 12."}

Denmark

Earliest CTIS Part Ii Submission Date

03-11-2025

Latest Decision Or Authorization Date

07-11-2025

Processing Time Days

4

Number Of Sites

3

Number Of Participants

60

Primary sponsor

Full Name

Arctic Therapeutics hf.

Organisation Type

Pharmaceutical company

Country Of Registered Address

Iceland

Contract research organisations

Name

Blueskin A/S

Responsibilities

sponsorDuties codes: 1,11,12,2,3,5,6,7,8

Third parties

• {"country":"Iceland","full_name":"Pharmarctica ehf.","duties_or_roles":"sponsorDuties codes: 14","organisation_type":"Pharmaceutical company"}
• {"country":"Denmark","full_name":"Blueskin A/S","duties_or_roles":"sponsorDuties codes: 1,11,12,2,3,5,6,7,8","organisation_type":"SME"}
• {"country":"United States","full_name":"Canfield Scientific Inc.","duties_or_roles":"Central imaging reader (sponsorDuties code: 15)","organisation_type":"Pharmaceutical company"}
• {"country":"Denmark","full_name":"Ozack ApS","duties_or_roles":"sponsorDuties codes: 12","organisation_type":"Pharmaceutical company"}
• {"country":"Denmark","full_name":"Nordic Bioscience A/S","duties_or_roles":"Central lab (sponsorDuties code: 15); sponsorDuties code: 4","organisation_type":"Pharmaceutical company"}