Bispebjerg Hospital | Dermatologisk Afdeling
Status and phase
Conditions
Treatments
Study type
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About
Actinic keratosis (AK), also known as solar keratosis, is a common skin condition characterised by abnormal growth of skin cells caused by long-term sun exposure. AK is considered to be a precancerous lesion, and is therefore commonly treated to reduce the risk of malignant transformation into skin cancer.
The trial is a randomised, double-blind, vehicle-controlled, dose-comparison trial in which adult subjects with AK grade 1 or 2 will be treated with AVX001 silicone-based gel in doses of 1% or 3% or with a gel vehicle for a 4-week field-directed treatment period. Subjects will be followed up for 8 weeks after the treatment period. The primary objective is to evaluate the local tolerability of daily applications of AVX001 gel in doses of 1% or 3% and compare with vehicle.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
Signed and dated informed consent
≥ 18 years of age
Fluent in Danish
Clinical AK diagnosis confirmed by PI.
Present an area of 25cm2 with 4 to 8 AK lesions located in face, neck or chest AK lesions in target area severity grade 1 or 2 as defined by the Olsen clinical Criteria for AK
Able to and willing to follow trial procedures including application of AVX001 and using the Study App.
Have a suitable smartphone to complete the trial tasks (Android operating system: Android 8.1 or higher; iPhone with iOS 12.4 or higher)
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.
Such methods include:
Exclusion criteria
AK lesions classified as Olsen grade 3 in target area
Atypical AK lesions in the target area, including suspected SCC or BCC
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
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
Received immunosuppressive/immunomodulating drugs including but not limited to methotrexate, cyclosporine, azathioprine, oral retinoids, 6 months prior to baseline visit.
Received systemic corticosteroids including but not limited to betamethasone, prednisone, dexamethasone, methylprednisolone (except if via inhale or intranasal delivery) 6 months prior to baseline visit.
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
Recipient of organ transplant including but not limited to bone marrow, kidney, liver, heart
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.
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
Received treatment with any non-approved drug substance within the last 4 weeks prior to baseline visit.
Known allergy or intolerance to fish, shellfish or fish oil
Concurrent participation in any other clinical trial or participation in any clinical trial treatments 4 weeks prior to enrolment.
Subject is pregnant or lactating
Primary purpose
Allocation
Interventional model
Masking
60 participants in 3 patient groups, including a placebo group
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Data sourced from clinicaltrials.gov
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