Acne Vulgaris on the Face
Conditions
Keywords
Acne vulgaris
Brief 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.
Interventions
DRUGAT-004
Participants receiving AT-004 topical application
DRUGPlacebo
Participants receiving matching placebo topical application
Sponsors
Arctic Therapeutics
Blueskin AS
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Treatment-Emergent Adverse Events | 12 weeks | 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. |
| Laboratory safety parameters | 12 weeks | Safety labs parameters not being outside of normal ranges and/or not clinically significant as assessed by the PI. |
| Incidence of inflammatory and non-inflammatory lesions | 12 weeks | Incidence of inflammatory and non-inflammatory lesions at baseline and week 8. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Evaluation of efficacy in terms of Investigator Global Assessment (IGA) | 12 weeks | 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. |
| Health-related quality of life after AT-004 administered topically in individuals with acne vulgaris | 12 weeks | 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" |
Countries
Denmark
Outcome results
None listed