Actinic keratosis Skin and Connective Tissue Diseases
Conditions
Interventions
All participants will receive Adex Gel, and will be asked to apply the gel three times daily for 12 weeks. Participants will attend 4 study visits at baseline, 4, 8 and 12 weeks.
Sponsors
Dermal Laboratories Ltd
Eligibility
Sex/Gender
All
Age
18 Years to 110 Years
Inclusion criteria
Inclusion criteria: A patient must meet all the following conditions to be included in the study: 1. Patient must voluntarily sign and date an informed consent form, approved by a Research Ethics Committee (REC), prior to the initiation of any screening or study specific procedures 2. Adult patient aged =18 years 3. Fitzpatrick Skin Phototype I, II, or III (Light to medium skin types characterised by a tendency to burn or sunburn, with limited to moderate tanning ability) as confirmed by the Investigator 4. Has multiple (>1) visible, discrete, AK lesions clinically typical of Olsen grade I or II on any skin areas above the neck 5. Has an AKASI score of between =0.8 to =6.8 6. Willing to avoid prolonged direct sun exposure, tanning booths, sunlamps, or other UV light sources on the treatment area during the study period 7. Willing to refrain from taking vitamin B3 supplements or oral niacinamide/nicotinamide supplements during the study period 8. Willing and able to understand and comply with all study requirements 9. Willing to avoid the use of new facial personal care products (e.g., make-up, soaps, toners or moisturisers) or change any currently used brands during the study period 10. Patient must be free from any other clinically significant dermatological conditions (other than AK) that may interfere with the study evaluations 11. Patient must be sufficiently proficient in the English language to understand and comply with study
Exclusion criteria
Exclusion criteria: A patient will not be permitted to enter the study if any of the following apply: 1. Has a pre-existing facial or scalp dermatologic condition, including those that may be inactive or dormant (e.g., acute skin inflammation, atopic dermatitis, eczema, rosacea, psoriasis, severe acne, seborrheic dermatitis, peri-oral dermatitis, post inflammatory hyperpigmentation or other hyperpigmentation, history of erosive pustular dermatosis) that could interfere with the study evaluations, lesion counts, confound results, or impact patient safety, as assessed and confirmed by the investigator 2. Has very thick, hyperkeratotic, hypertrophic, atypical, or rapidly changing AK lesions (Olsen grade III) 3. Has used topical treatments for AK in the treatment area (e.g., 5-fluorouracil, imiquimod, diclofenac, tirbanibulin, salicylic acid, corticosteroids or retinoids) within 30 days prior to screening 4. Has used chemical peel, dermabrasion, laser therapy, PUVA (psoralen plus ultraviolet A) therapy or UVB (Ultraviolet B) therapy within 6 months prior to screening 5. Has used immunomodulators, systemic chemotherapeutics or immunosuppressive therapies, interferon, oral/injectable corticosteroids, oral retinoids, or cytotoxic drugs within 30 days prior to screening 6. Has diagnosed basal cell carcinoma, squamous cell carcinoma or melanoma 7. Has a history of malignancy not in remission for =5 years 8. Has symptoms of clinically significant illness that may influence their participation 9. Has facial hair, abnormal skin pigmentation or body art on the face that may interfere with accurate assessment of AK 10. Has any condition (e.g. xeroderma pigmentosum (XP), albinism, or Bloom’s syndrome) that, in the opinion of the investigator, may influence treatment evaluation or other assessments 11. Has participated in a clinical trial/investigation involving an investigational product (investigational medicinal product/medical device) within 30 days prior to screening 12. Has known hypersensitivity, intolerance, or allergy to Adex Gel or any of its components 13. Is an employee of the investigative site, Sponsor or Clinical Research Organisation (CRO), or a first degree relative of such employees 14. Has an inability to communicate adequately (e.g., language barriers, or neurodevelopmental disorders) in the opinion of the investigator 15. Any other condition that, in the opinion of the investigator, renders the participant unfit for study participation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The severity of actinic keratosis measured using the Actinic Keratosis Area and Severity Index (AKASI) at baseline, 4, 8 and 12 weeks | — |
Countries
England, United Kingdom
Contacts
Public ContactErika Houston
Outcome results
None listed