Copenhagen Actinic Keratosis Study
- Conditions
- Actinic KeratosisMedDRA version: 20.0Level: PTClassification code 10000614Term: Actinic keratosisSystem Organ Class: 10040785 - Skin and subcutaneous tissue disordersTherapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
- Registration Number
- EUCTR2021-000934-32-DK
- Lead Sponsor
- Coegin Pharma AB
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 60
1.Participants must be= 18 years of age
2. Fluent in Danish
3. Actinic Keratosis (AK) diagnosed by Central assessors (based on uploaded photo)
4. Present an area of 25cm2 with 4 to 8 AK lesions located in face, neck or chest
5. AK lesions in target area severity grade 1 or 2 as defined by the Olsen clinical Criteria for AK
6. Able to and willing to follow trial procedures including application of AVX001 and using the Study App.
7. Have a suitable smartphone to complete the trial tasks (Android operating system: Android 8.0 or higher; iPhone with iOS 12.4 or higher
8. Female Subjects must either be of non-childbearing potential (either be surgically sterile (hysterectomy or tubal ligation) or post-menopausal) or must be using a highly effective method of contraception. Contraception must be maintained for the duration of the study.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 30
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 30
1. AK lesions classified as Olsen grade 3 in target area
2. Atypical AK lesions in the target area, including suspected SCC or BCC
3. Under suspicion of ,or current skin cancer diagnosis in the target area.
subjects who had BCC, SCC or melanoma and have completed curative therapy at least 12 months prior to screening and are in remission can be considered to participate in the trial by investigator’s discretion
4. Any dermatological condition in the target area that can be exacerbated by treatment or affect trial assessments, including but not limited to psoriasis vulgaris AD, rosacea, urticaria, scabies, and herpes simplex
5. Received immunosuppressive/immunomodulating drugs including but not limited to methotrexate, cyclosporine, azathioprine, oral retinoids, 6 months prior to baseline visit.
6. Received systemic corticosteroids including but not limited to betamethasone, prednisone, dexamethasone, metilprednisolone (except if via inhale or intranasal delivery) 6 months prior to baseline visit.
7. Received lesion or field directed therapy within 2 cm of the target area for trial treatment one month prior to baseline visit, including
topical drugs, including but not limited to topical fluorouracil, imiquimod, ingenol mebutate and diclofenac.
destructive therapies, including but not limited to surgery, cryotherapy, dermabrasion, and photodynamic therapy
field ablation treatments, including but not limited to chemical peels, laser resurfacing
8. Recipient of organ transplant including but not limited to bone marrow, kidney, liver, heart
9. Any unstable neurological or psychiatric disorder based on the investigator's opinion which has the potential to affect the safety of the subject, influence on trial objectives or impede the subject’s ability to complete the trial.
10. History of chronic alcohol or drug abuse within 12 months prior to screening or any condition associated with poor compliance at the investigator’s discretion
11. Received treatment with any non-approved drug substance within the last 4 weeks prior to baseline visit.
12. Known allergy or intolerance to fish, shellfish or fish oil
13. Concurrent participation in any other clinical trial or participation in any clinical trial treatments 4 weeks prior to enrollment.
14. Subject is pregnant or lactating
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method